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Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00848250
First Posted: February 20, 2009
Last Update Posted: July 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gregory Fleming, Vanderbilt University Medical Center
Results First Submitted: May 1, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
29 participants were eligible, 8 refused participation

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    ACE Inhibitor   No ACE Inhibitor
STARTED   11   10 
COMPLETED   11   9 
NOT COMPLETED   0   1 
surgery was completed without cardiopulm                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   ACE Inhibitor   No ACE Inhibitor   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   9   20 
Age 
[Units: Months]
Mean (Standard Deviation)
 13.7  (3.5)   20.8  (6.5)   17.2  (5.02) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  36.4%      3  33.3%      7  35.0% 
Male      7  63.6%      6  66.7%      13  65.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   11   9   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   (PAI-1) Plasminogen Activator Inhibitor -1 Antigen   [ 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 ]

2.  Primary:   t-PA (Tissue-type Plasminogen Activator) Antigen   [ Time Frame: Baseline (prior to surgery) to postoperative day 1 ]

3.  Secondary:   IL-6 (Interleukin-6)   [ Time Frame: Baseline (pre-surgery) to postoperative day 1 ]

4.  Secondary:   IL-8 (Interleukin-8)   [ Time Frame: Baseline (pre-surgery) to postoperative day 1 ]

5.  Secondary:   (MAP) Mean Arterial Blood Pressure   [ Time Frame: Baseline (prior to surgery) to postoperative day 1 ]

6.  Secondary:   Postoperative Bleeding   [ Time Frame: 24 hours ]

7.  Secondary:   Postoperative Renal Function   [ Time Frame: Baseline (prior to surgery) to postoperative day 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: mias.pretorius@vanderbilt.edu



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