Trial Outcomes & Findings for Angiotensin II in General Anesthesia (NCT NCT03733145)
NCT ID: NCT03733145
Last Updated: 2025-08-24
Results Overview
The median dose required to increase the SBP in these 3 cohorts with essential hypertension (ACE inhibitor, ARB, or those on another class of hypertensive agents) to within 5% of baseline or higher will be calculated.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
up to 1 hour
Results posted on
2025-08-24
Participant Flow
Participant milestones
| Measure |
Participants on ACE Inhibitors
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
11
|
|
Overall Study
COMPLETED
|
7
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
Reasons for withdrawal
| Measure |
Participants on ACE Inhibitors
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Overall Study
screenfail
|
3
|
3
|
2
|
Baseline Characteristics
Angiotensin II in General Anesthesia
Baseline characteristics by cohort
| Measure |
Participants on ACE Inhibitors
n=7 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=9 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.25 years
STANDARD_DEVIATION 6.16 • n=99 Participants
|
67.75 years
STANDARD_DEVIATION 5.87 • n=107 Participants
|
67.22 years
STANDARD_DEVIATION 6.76 • n=206 Participants
|
65.29 years
STANDARD_DEVIATION 7.16 • n=157 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
11 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
24 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
19 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: up to 1 hourPopulation: ACE Inhibitor Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol ARB Arm: 2 patients did not reach the treatment goal in this group and were therefore excluded from primary outcome analysis Other Classes of Antihypertensive Agents Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
The median dose required to increase the SBP in these 3 cohorts with essential hypertension (ACE inhibitor, ARB, or those on another class of hypertensive agents) to within 5% of baseline or higher will be calculated.
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=6 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Dose Required to Increase the Systolic Blood Pressure (SBP)
|
35 ng/kg/min
Interval 35.0 to 45.0
|
43 ng/kg/min
Interval 31.0 to 54.0
|
45 ng/kg/min
Interval 34.0 to 45.0
|
SECONDARY outcome
Timeframe: up to 1 hourPopulation: ACE Inhibitor Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Agents Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Bradykinin 1-8
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Bradykinin 1-8
|
127043 pmol/L
Interval 103938.0 to 180738.0
|
105405 pmol/L
Interval 71387.0 to 122527.0
|
101169 pmol/L
Interval 75851.0 to 130402.0
|
SECONDARY outcome
Timeframe: Up to 1 hourPopulation: ACE Inhibitor Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Agents: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Bradykinin 1-7
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Bradykinin 1-7
|
24457 pmol/L
Interval 19026.0 to 35010.0
|
19335 pmol/L
Interval 11044.0 to 36966.0
|
17438 pmol/L
Interval 11906.0 to 25482.0
|
SECONDARY outcome
Timeframe: Up to 1 hourPopulation: ACE Inhibitor Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Bradykinin 1-5
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Bradykinin 1-5
|
2341 pmol/L
Interval 1483.0 to 4095.0
|
353 pmol/L
Interval 249.0 to 605.0
|
375 pmol/L
Interval 251.0 to 534.0
|
SECONDARY outcome
Timeframe: Up to 1 hourPopulation: ACE Inhibitor Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Agents Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Aldosterone
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Aldosterone
|
293 pmol/L
Interval 223.0 to 362.0
|
293 pmol/L
Interval 223.0 to 362.0
|
230 pmol/L
Interval 168.0 to 308.0
|
SECONDARY outcome
Timeframe: Up to 1 hourPopulation: ACE Inhibitor Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Agents Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Angiotensin I
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Angiotensin I
|
8.7 pmol/L
Interval 0.0 to 37.9
|
1.8 pmol/L
Interval 0.0 to 16.7
|
0 pmol/L
Interval 0.0 to 6.3
|
SECONDARY outcome
Timeframe: up to 1 hourPopulation: ACE Inhibitors Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Agents Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Angiotensin II
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Angiotensin II
|
10.9 pmol/L
Interval 3.7 to 370.1
|
31.2 pmol/L
Interval 5.0 to 758.5
|
10.2 pmol/L
Interval 0.0 to 326.2
|
SECONDARY outcome
Timeframe: Up to 1 hourPopulation: ACE Inhibitors Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Agents: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Angiotensin IV
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Angiotensin IV
|
0 pmol/L
Interval 0.0 to 11.0
|
1 pmol/L
Interval 0.0 to 18.7
|
0 pmol/L
Interval 0.0 to 8.2
|
SECONDARY outcome
Timeframe: Up to 1 hourPopulation: ACE Inhibitors Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Agents Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Angiotensin 1-7
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Angiotensin 1-7
|
8.7 pmol/L
Interval 0.0 to 37.9
|
1.8 pmol/L
Interval 0.0 to 16.7
|
0 pmol/L
Interval 0.0 to 6.3
|
SECONDARY outcome
Timeframe: Up to 1 hourPopulation: ACE Inhibitors Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Agents Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Angiotensin 1-5
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Angiotensin 1-5
|
0 pmol/L
Interval 0.0 to 0.0
|
0 pmol/L
Interval 0.0 to 28.8
|
0 pmol/L
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 1 hourPopulation: ACE Inhibitors Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Agents: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Angiotensin 1-9
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Angiotensin 1-9
|
0 pmol/L
Interval 0.0 to 0.0
|
0 pmol/L
Interval 0.0 to 0.0
|
0 pmol/L
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 1 hourPopulation: ACE Inhibitors Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Agents Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Angiotensin 2-10
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Angiotensin 2-10
|
0 pmol/L
Interval 0.0 to 5.8
|
0 pmol/L
Interval 0.0 to 0.0
|
0 pmol/L
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 1 hourPopulation: ACE Inhibitors Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Agents: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Angiotensin 2-7
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Angiotensin 2-7
|
0 pmol/L
Interval 0.0 to 0.0
|
0 pmol/L
Interval 0.0 to 0.0
|
0 pmol/L
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 1 hourPopulation: ACE Inhibitors Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol Other Classes of Antihypertensive Agents: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol
Median serum level of Angiotensin 3-7
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=5 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Angiotensin 3-7
|
0 pmol/L
Interval 0.0 to 2.33
|
0 pmol/L
Interval 0.0 to 0.0
|
0 pmol/L
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Up to 1 hourPopulation: ACE Inhibitors Arm: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol, 2 patients unable to get sample. ARBs Arm: 1 patient unable to get sample. Other Classes of Antihypertensive Agents: 2 patients did not experience hypotension and therefore did not receive the Ang II per protocol, 2 patients unable to get sample.
Median serum level of Angiotensin 1-12
Outcome measures
| Measure |
Participants on ACE Inhibitors
n=3 Participants
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=7 Participants
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=5 Participants
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Median Serum Level of Angiotensin 1-12
|
940 pmol/L
Interval 788.0 to 982.0
|
1011 pmol/L
Interval 846.0 to 1138.0
|
674 pmol/L
Interval 344.0 to 1043.0
|
Adverse Events
Participants on ACE Inhibitors
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Participants on ARBs
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Other Classes of Antihypertensive Agents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants on ACE Inhibitors
n=5 participants at risk
Participants taking ACE inhibitors (angiotensin-converting enzyme inhibitors)will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Participants on ARBs
n=8 participants at risk
Participants taking ARBs (angiotensin-receptor blockers) will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
Other Classes of Antihypertensive Agents
n=7 participants at risk
Participants taking any other class of Antihypertensive Agents will be placed into this group. Intervention: Drug: Angiotensin II.
Angiotensin II: Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
|
|---|---|---|---|
|
Vascular disorders
Leg Swelling
|
20.0%
1/5 • 7 days
|
0.00%
0/8 • 7 days
|
0.00%
0/7 • 7 days
|
|
Eye disorders
Blurred Vision
|
0.00%
0/5 • 7 days
|
12.5%
1/8 • 7 days
|
0.00%
0/7 • 7 days
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/5 • 7 days
|
12.5%
1/8 • 7 days
|
0.00%
0/7 • 7 days
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/5 • 7 days
|
12.5%
1/8 • 7 days
|
0.00%
0/7 • 7 days
|
Additional Information
Rohesh J. Fernando, MD
Atrium Health Wake Forest Baptist
Phone: 336.716.2712
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place