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Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

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ClinicalTrials.gov Identifier: NCT00848250
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Gregory Fleming, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Congenital Heart Disease
Interventions Drug: Angiotensin Converting Enzyme Inhibitor
Other: No ACE Inhibitor
Enrollment 21
Recruitment Details  
Pre-assignment Details 29 participants were eligible, 8 refused participation
Arm/Group Title ACE Inhibitor No ACE Inhibitor
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 11 10
Completed 11 9
Not Completed 0 1
Reason Not Completed
surgery was completed without cardiopulm             0             1
Arm/Group Title ACE Inhibitor No ACE Inhibitor Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 11 9 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 11 participants 9 participants 20 participants
13.7  (3.5) 20.8  (6.5) 17.2  (5.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
Female
4
  36.4%
3
  33.3%
7
  35.0%
Male
7
  63.6%
6
  66.7%
13
  65.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  18.2%
2
  22.2%
4
  20.0%
White
9
  81.8%
7
  77.8%
16
  80.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 9 participants 20 participants
11 9 20
1.Primary Outcome
Title (PAI-1) Plasminogen Activator Inhibitor -1 Antigen
Hide Description [Not Specified]
Time Frame Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACE Inhibitor No ACE Inhibitor
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 9
Mean (Standard Error)
Unit of Measure: ng/ml
Baseline, Pre- Cardiopulmonary bypass (CPD) 4.59  (2.36) 3.78  (0.58)
at 30 minutes on CPB 13.59  (2.8) 17.8  (2.49)
Completion of CPB 54.74  (6.63) 58.56  (0.86)
postoperative day 1 (at 8:00AM) 57.13  (12.14) 88.74  (14.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE Inhibitor, No ACE Inhibitor
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title t-PA (Tissue-type Plasminogen Activator) Antigen
Hide Description [Not Specified]
Time Frame Baseline (prior to surgery) to postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACE Inhibitor No ACE Inhibitor
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 9
Mean (Standard Error)
Unit of Measure: ng/ml
Baseline, Pre- Cardiopulmonary bypass (CPD) 10.81  (1.0) 8.31  (0.94)
On CPB for 30 minutes 12.97  (5.43) 20.44  (6.38)
At completion of CPB 16.83  (1.84) 28.03  (3.15)
postoperative day 1 (at 8:00AM) 14.36  (3.05) 20.24  (1.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE Inhibitor, No ACE Inhibitor
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method ANOVA
Comments Repeated measures
3.Secondary Outcome
Title IL-6 (Interleukin-6)
Hide Description [Not Specified]
Time Frame Baseline (pre-surgery) to postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACE Inhibitor No ACE Inhibitor
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 9
Mean (Standard Error)
Unit of Measure: pg/ml
Baseline, Pre- Cardiopulmonary bypass (CPD) 2.29  (1.27) 3.06  (1.76)
on CPB for 30min 9.64  (3.23) 13.08  (3.49)
At completion of CPB 215.84  (32.59) 141.00  (91.56)
postoperative day 1 (at 8:00AM) 401.69  (123.66) 119.13  (33.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE Inhibitor, No ACE Inhibitor
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANOVA
Comments Repeated measures
4.Secondary Outcome
Title IL-8 (Interleukin-8)
Hide Description [Not Specified]
Time Frame Baseline (pre-surgery) to postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACE Inhibitor No ACE Inhibitor
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 9
Mean (Standard Error)
Unit of Measure: pg/mL
Baseline (Before going on cardiopulmonary bypass 11.69  (2.07) 15.56  (3.61)
at 30 minutes on CPB 20.76  (4.57) 36.91  (16.92)
Admission to ICU following surgery 213.74  (39.39) 244.86  (121.13)
postoperative day 1 (at 8:00AM) 201.05  (66.91) 127.03  (42.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE Inhibitor, No ACE Inhibitor
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method ANOVA
Comments Repeated measures
5.Secondary Outcome
Title (MAP) Mean Arterial Blood Pressure
Hide Description [Not Specified]
Time Frame Baseline (prior to surgery) to postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACE Inhibitor No ACE Inhibitor
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 9
Mean (Standard Error)
Unit of Measure: mmHg
Baseline, Pre- Cardiopulmonary bypass (CPD) 42.65  (1.68) 47.82  (3.6)
at 30 minutes on CPB 53.02  (3.16) 53.52  (2.93)
At completion of CPB 60.35  (4.23) 59.48  (3.81)
postoperative day 1 (at 8:00AM) 60.63  (4.23) 64.16  (3.33)
6.Secondary Outcome
Title Postoperative Bleeding
Hide Description Chest tube output at 4 and 24 hours after completion of surgery
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACE Inhibitor No ACE Inhibitor
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 9
Mean (Standard Error)
Unit of Measure: mL/kg
Chest tube output in 4 hrs 38.4  (13.8) 19.8  (2.9)
Chest tube output in 24 hrs 76.3  (20.7) 43.2  (6.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE Inhibitor, No ACE Inhibitor
Comments P-value is for comparison of chest tube output at 24 hours
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Postoperative Renal Function
Hide Description Acute kidney injury occurring
Time Frame Baseline (prior to surgery) to postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ACE Inhibitor No ACE Inhibitor
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 9
Measure Type: Number
Unit of Measure: Percentage of subject with AKI
54.5 33.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ACE Inhibitor, No ACE Inhibitor
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame From the start of surgery until hospital discharge, approximately 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ACE Inhibitor No ACE Inhibitor
Hide Arm/Group Description

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

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

All-Cause Mortality
ACE Inhibitor No ACE Inhibitor
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)      0/9 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
ACE Inhibitor No ACE Inhibitor
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/11 (36.36%)      2/9 (22.22%)    
Cardiac disorders     
ECMO  [1]  1/11 (9.09%)  1 0/9 (0.00%)  0
Surgical and medical procedures     
Surgical re-exploration   3/11 (27.27%)  3 2/9 (22.22%)  2
Indicates events were collected by systematic assessment
[1]
Extracorporeal membrane oxygenation
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ACE Inhibitor No ACE Inhibitor
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/11 (36.36%)      0/9 (0.00%)    
Cardiac disorders     
Permanent pacemaker  [1]  1/11 (9.09%)  1 0/9 (0.00%)  0
Pleural effusion  [2]  3/11 (27.27%)  3 0/9 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Did the patient require a permanent pacemaker after surgery?
[2]
Did the patient develop a pleural effusion?
While patients were randomized to preoperative ACE inhibition, the present study was neither blinded nor placebo-controlled. However, the dose and type of ACE inhibitor were similar between the two study groups.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mias Pretorius
Organization: Vanderbilt University Medical Center
Phone: 615-8757402
Responsible Party: Gregory Fleming, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00848250     History of Changes
Other Study ID Numbers: 071078
First Submitted: February 5, 2009
First Posted: February 20, 2009
Results First Submitted: May 1, 2017
Results First Posted: July 26, 2017
Last Update Posted: July 26, 2017