Trial Outcomes & Findings for Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study (NCT NCT01393782)
NCT ID: NCT01393782
Last Updated: 2024-04-12
Results Overview
The primary endpoint in the study will be the effect of AII on the standing dose of norepinephrine which is required to maintain a mean arterial pressure (MAP) of 65 mmHg.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
1 hour after initiation of angiotensin II (ATII)
Results posted on
2024-04-12
Participant Flow
Participant milestones
| Measure |
Angiotensin
The angiotensin arm will receive angiotensin II acetate at an initial dose of 20ng/kg/min, titratable during the study (6 hours) for MAP goals as outlined in the protocol.
|
Control
Control patients will receive placebo intravenously equal in duration, color and volume to the intervention arm's angiotensin II.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study
Baseline characteristics by cohort
| Measure |
Angiotensin
n=10 Participants
The angiotensin arm will receive angiotensin II acetate at an initial dose of 20ng/kg/min, titratable during the study (6 hours) for MAP goals as outlined in the protocol.
|
Control
n=10 Participants
Control patients will receive placebo intravenously equal in duration, color and volume to the intervention arm's angiotensin II.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 17.5 • n=99 Participants
|
57.3 years
STANDARD_DEVIATION 12.4 • n=107 Participants
|
62.9 years
STANDARD_DEVIATION 15.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Baseline Sequential Organ Failure Assessment (SOFA) score, Continous
|
14.9 Scores on a scale 0-24 (higher is worse)
STANDARD_DEVIATION 2.8 • n=99 Participants
|
16.9 Scores on a scale 0-24 (higher is worse)
STANDARD_DEVIATION 2.9 • n=107 Participants
|
15.9 Scores on a scale 0-24 (higher is worse)
STANDARD_DEVIATION 3.0 • n=206 Participants
|
|
Acute physiology and chronic health evaluation (APACHE) score, continous
|
27.2 Scores on a scale 0-71 (higher is worse)
STANDARD_DEVIATION 9.7 • n=99 Participants
|
34 Scores on a scale 0-71 (higher is worse)
STANDARD_DEVIATION 6.8 • n=107 Participants
|
30.6 Scores on a scale 0-71 (higher is worse)
STANDARD_DEVIATION 8.9 • n=206 Participants
|
|
Ischemic heart disease
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Congestive heart failure
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Chronic obstructive pulmonary disease
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Diabetes
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Chronic kidney disease
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Hemodialysis
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Liver disease
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Cancer
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Immunocompromised state (as defined by steroid therapy or history of immunocompromise disease)
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Steroids
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Hypertension
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Cerebrovascular accident
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Acute kidney injury
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Baseline Norepinephrine dose
|
19.8 mcg/min
STANDARD_DEVIATION 11.7 • n=99 Participants
|
30.3 mcg/min
STANDARD_DEVIATION 20.4 • n=107 Participants
|
25.1 mcg/min
STANDARD_DEVIATION 17.0 • n=206 Participants
|
|
Baseline Vasopressin dose
|
0.03 units/min
STANDARD_DEVIATION 0.02 • n=99 Participants
|
0.05 units/min
STANDARD_DEVIATION 0.02 • n=107 Participants
|
0.04 units/min
STANDARD_DEVIATION 0.02 • n=206 Participants
|
PRIMARY outcome
Timeframe: 1 hour after initiation of angiotensin II (ATII)The primary endpoint in the study will be the effect of AII on the standing dose of norepinephrine which is required to maintain a mean arterial pressure (MAP) of 65 mmHg.
Outcome measures
| Measure |
Angiotensin
n=10 Participants
The angiotensin arm will receive angiotensin II acetate at an initial dose of 20ng/kg/min, titratable during the study (6 hours) for MAP goals as outlined in the protocol.
|
Control
n=10 Participants
Control patients will receive placebo intravenously equal in duration, color and volume to the intervention arm's angiotensin II.
|
|---|---|---|
|
Standing Dose of Norepinephrine Which is Required to Maintain a Mean Arterial Pressure (MAP) of 65 mmHg - Hour 1
|
7.4 mcg/min
Standard Deviation 12.4
|
27.6 mcg/min
Standard Deviation 29.3
|
PRIMARY outcome
Timeframe: 2 hours after initiation of ATIIThe primary endpoint in the study will be the effect of AII on the standing dose of norepinephrine which is required to maintain a MAP of 65 mmHg.
Outcome measures
| Measure |
Angiotensin
n=10 Participants
The angiotensin arm will receive angiotensin II acetate at an initial dose of 20ng/kg/min, titratable during the study (6 hours) for MAP goals as outlined in the protocol.
|
Control
n=10 Participants
Control patients will receive placebo intravenously equal in duration, color and volume to the intervention arm's angiotensin II.
|
|---|---|---|
|
Standing Dose of Norepinephrine Which is Required to Maintain a MAP of 65 mmHg - Hour 2
|
7.3 mcg/min
Standard Deviation 11.9
|
28.6 mcg/min
Standard Deviation 30.2
|
SECONDARY outcome
Timeframe: 30 days30 day post dose mortality will be assessed. Subjects discharged prior to day 30 will be contacted by telephone for this assessment.
Outcome measures
| Measure |
Angiotensin
n=10 Participants
The angiotensin arm will receive angiotensin II acetate at an initial dose of 20ng/kg/min, titratable during the study (6 hours) for MAP goals as outlined in the protocol.
|
Control
n=10 Participants
Control patients will receive placebo intravenously equal in duration, color and volume to the intervention arm's angiotensin II.
|
|---|---|---|
|
Mortality
|
5 Participants
|
6 Participants
|
Adverse Events
Angiotensin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 5 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Angiotensin
n=10 participants at risk
The angiotensin arm will receive angiotensin II acetate at an initial dose of 20ng/kg/min, titratable during the study (6 hours) for MAP goals as outlined in the protocol.
|
Control
n=10 participants at risk
Control patients will receive placebo intravenously equal in duration, color and volume to the intervention arm's angiotensin II.
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
20.0%
2/10
|
0.00%
0/10
|
Additional Information
Clinical Trials Unit, Department of Anesthesiology and Critical Care Medicine
George Washington University Medical Faculty Associates
Phone: 202-715-4750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place