Trial Outcomes & Findings for Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children (NCT NCT00848250)
NCT ID: NCT00848250
Last Updated: 2017-07-26
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1
Results posted on
2017-07-26
Participant Flow
29 participants were eligible, 8 refused participation
Participant milestones
| Measure |
ACE Inhibitor
Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery
|
No ACE Inhibitor
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
ACE Inhibitor
Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery
|
No ACE Inhibitor
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
|---|---|---|
|
Overall Study
surgery was completed without cardiopulm
|
0
|
1
|
Baseline Characteristics
Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
Baseline characteristics by cohort
| Measure |
ACE Inhibitor
n=11 Participants
Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery
|
No ACE Inhibitor
n=9 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.7 months
STANDARD_DEVIATION 3.5 • n=39 Participants
|
20.8 months
STANDARD_DEVIATION 6.5 • n=41 Participants
|
17.2 months
STANDARD_DEVIATION 5.02 • n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=39 Participants
|
9 participants
n=41 Participants
|
20 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1Outcome measures
| Measure |
ACE Inhibitor
n=11 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
No ACE Inhibitor
n=9 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
|---|---|---|
|
(PAI-1) Plasminogen Activator Inhibitor -1 Antigen
Baseline, Pre- Cardiopulmonary bypass (CPD)
|
4.59 ng/ml
Standard Error 2.36
|
3.78 ng/ml
Standard Error 0.58
|
|
(PAI-1) Plasminogen Activator Inhibitor -1 Antigen
at 30 minutes on CPB
|
13.59 ng/ml
Standard Error 2.8
|
17.8 ng/ml
Standard Error 2.49
|
|
(PAI-1) Plasminogen Activator Inhibitor -1 Antigen
Completion of CPB
|
54.74 ng/ml
Standard Error 6.63
|
58.56 ng/ml
Standard Error 0.86
|
|
(PAI-1) Plasminogen Activator Inhibitor -1 Antigen
postoperative day 1 (at 8:00AM)
|
57.13 ng/ml
Standard Error 12.14
|
88.74 ng/ml
Standard Error 14.02
|
PRIMARY outcome
Timeframe: Baseline (prior to surgery) to postoperative day 1Outcome measures
| Measure |
ACE Inhibitor
n=11 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
No ACE Inhibitor
n=9 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
|---|---|---|
|
t-PA (Tissue-type Plasminogen Activator) Antigen
Baseline, Pre- Cardiopulmonary bypass (CPD)
|
10.81 ng/ml
Standard Error 1.0
|
8.31 ng/ml
Standard Error 0.94
|
|
t-PA (Tissue-type Plasminogen Activator) Antigen
On CPB for 30 minutes
|
12.97 ng/ml
Standard Error 5.43
|
20.44 ng/ml
Standard Error 6.38
|
|
t-PA (Tissue-type Plasminogen Activator) Antigen
At completion of CPB
|
16.83 ng/ml
Standard Error 1.84
|
28.03 ng/ml
Standard Error 3.15
|
|
t-PA (Tissue-type Plasminogen Activator) Antigen
postoperative day 1 (at 8:00AM)
|
14.36 ng/ml
Standard Error 3.05
|
20.24 ng/ml
Standard Error 1.82
|
SECONDARY outcome
Timeframe: Baseline (pre-surgery) to postoperative day 1Outcome measures
| Measure |
ACE Inhibitor
n=11 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
No ACE Inhibitor
n=9 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
|---|---|---|
|
IL-6 (Interleukin-6)
Baseline, Pre- Cardiopulmonary bypass (CPD)
|
2.29 pg/ml
Standard Error 1.27
|
3.06 pg/ml
Standard Error 1.76
|
|
IL-6 (Interleukin-6)
on CPB for 30min
|
9.64 pg/ml
Standard Error 3.23
|
13.08 pg/ml
Standard Error 3.49
|
|
IL-6 (Interleukin-6)
At completion of CPB
|
215.84 pg/ml
Standard Error 32.59
|
141.00 pg/ml
Standard Error 91.56
|
|
IL-6 (Interleukin-6)
postoperative day 1 (at 8:00AM)
|
401.69 pg/ml
Standard Error 123.66
|
119.13 pg/ml
Standard Error 33.54
|
SECONDARY outcome
Timeframe: Baseline (pre-surgery) to postoperative day 1Outcome measures
| Measure |
ACE Inhibitor
n=11 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
No ACE Inhibitor
n=9 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
|---|---|---|
|
IL-8 (Interleukin-8)
Baseline (Before going on cardiopulmonary bypass
|
11.69 pg/mL
Standard Error 2.07
|
15.56 pg/mL
Standard Error 3.61
|
|
IL-8 (Interleukin-8)
at 30 minutes on CPB
|
20.76 pg/mL
Standard Error 4.57
|
36.91 pg/mL
Standard Error 16.92
|
|
IL-8 (Interleukin-8)
Admission to ICU following surgery
|
213.74 pg/mL
Standard Error 39.39
|
244.86 pg/mL
Standard Error 121.13
|
|
IL-8 (Interleukin-8)
postoperative day 1 (at 8:00AM)
|
201.05 pg/mL
Standard Error 66.91
|
127.03 pg/mL
Standard Error 42.48
|
SECONDARY outcome
Timeframe: Baseline (prior to surgery) to postoperative day 1Outcome measures
| Measure |
ACE Inhibitor
n=11 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
No ACE Inhibitor
n=9 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
|---|---|---|
|
(MAP) Mean Arterial Blood Pressure
Baseline, Pre- Cardiopulmonary bypass (CPD)
|
42.65 mmHg
Standard Error 1.68
|
47.82 mmHg
Standard Error 3.6
|
|
(MAP) Mean Arterial Blood Pressure
at 30 minutes on CPB
|
53.02 mmHg
Standard Error 3.16
|
53.52 mmHg
Standard Error 2.93
|
|
(MAP) Mean Arterial Blood Pressure
At completion of CPB
|
60.35 mmHg
Standard Error 4.23
|
59.48 mmHg
Standard Error 3.81
|
|
(MAP) Mean Arterial Blood Pressure
postoperative day 1 (at 8:00AM)
|
60.63 mmHg
Standard Error 4.23
|
64.16 mmHg
Standard Error 3.33
|
SECONDARY outcome
Timeframe: 24 hoursChest tube output at 4 and 24 hours after completion of surgery
Outcome measures
| Measure |
ACE Inhibitor
n=11 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
No ACE Inhibitor
n=9 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
|---|---|---|
|
Postoperative Bleeding
Chest tube output in 24 hrs
|
76.3 mL/kg
Standard Error 20.7
|
43.2 mL/kg
Standard Error 6.2
|
|
Postoperative Bleeding
Chest tube output in 4 hrs
|
38.4 mL/kg
Standard Error 13.8
|
19.8 mL/kg
Standard Error 2.9
|
SECONDARY outcome
Timeframe: Baseline (prior to surgery) to postoperative day 1Acute kidney injury occurring
Outcome measures
| Measure |
ACE Inhibitor
n=11 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
No ACE Inhibitor
n=9 Participants
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
|---|---|---|
|
Postoperative Renal Function
|
54.5 Percentage of subject with AKI
|
33.3 Percentage of subject with AKI
|
Adverse Events
ACE Inhibitor
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
No ACE Inhibitor
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACE Inhibitor
n=11 participants at risk
Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery
|
No ACE Inhibitor
n=9 participants at risk
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
|---|---|---|
|
Cardiac disorders
ECMO
|
9.1%
1/11 • Number of events 1 • From the start of surgery until hospital discharge, approximately 7 days
|
0.00%
0/9 • From the start of surgery until hospital discharge, approximately 7 days
|
|
Surgical and medical procedures
Surgical re-exploration
|
27.3%
3/11 • Number of events 3 • From the start of surgery until hospital discharge, approximately 7 days
|
22.2%
2/9 • Number of events 2 • From the start of surgery until hospital discharge, approximately 7 days
|
Other adverse events
| Measure |
ACE Inhibitor
n=11 participants at risk
Patients already on an ACE inhibitor will continue it until the day of surgery
Angiotensin Converting Enzyme Inhibitor: Patients randomized to this group will continue their current dose of ACE inhibitors until surgery
|
No ACE Inhibitor
n=9 participants at risk
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
No ACE Inhibitor: Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
|
|---|---|---|
|
Cardiac disorders
Permanent pacemaker
|
9.1%
1/11 • Number of events 1 • From the start of surgery until hospital discharge, approximately 7 days
|
0.00%
0/9 • From the start of surgery until hospital discharge, approximately 7 days
|
|
Cardiac disorders
Pleural effusion
|
27.3%
3/11 • Number of events 3 • From the start of surgery until hospital discharge, approximately 7 days
|
0.00%
0/9 • From the start of surgery until hospital discharge, approximately 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place