N/A
N=21
Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
Congenital Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00848250 ↗Enrolled (actual)
21
Serious AEs
30.0%
Results posted
Jul 2017
Primary outcome: Primary: (PAI-1) Plasminogen Activator Inhibitor -1 Antigen — 4.59; 3.78; 13.59; 17.8 ng/ml — p=0.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Angiotensin Converting Enzyme Inhibitor (Drug); No ACE Inhibitor (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY (PAI-1) Plasminogen Activator Inhibitor -1 Antigen |
4.59; 3.78; 13.59; 17.8; 54.74; 58.56 | 0.03 sig |
| PRIMARY t-PA (Tissue-type Plasminogen Activator) Antigen |
10.81; 8.31; 12.97; 20.44; 16.83; 28.03 | 0.13 |
| SECONDARY IL-6 (Interleukin-6) |
2.29; 3.06; 9.64; 13.08; 215.84; 141.00 | 0.02 sig |
| SECONDARY IL-8 (Interleukin-8) |
11.69; 15.56; 20.76; 36.91; 213.74; 244.86 | 0.67 |
| SECONDARY (MAP) Mean Arterial Blood Pressure |
42.65; 47.82; 53.02; 53.52; 60.35; 59.48 | — |
| SECONDARY Postoperative Bleeding |
38.4; 19.8; 76.3; 43.2 | 0.47 |
| SECONDARY Postoperative Renal Function |
54.5; 33.3 | 0.41 |
Summary
The purpose of this study is to determine whether ACE inhibitors alter the fibrinolytic, inflammatory, and hemodynamic response to cardiopulmonary bypass in infants and children with congenital heart disease.
Eligibility Criteria
Inclusion Criteria
- Infants or children (newborn to 17 years of age) undergoing cardiopulmonary bypass for elective surgical correction of a congenital heart defect.
- Patients must be taking an ACE inhibitor prior to their operation
Exclusion Criteria
- Patients in which discontinuing ACEIs is deemed unsafe by their primary cardiologist
- Any condition rendering the subjects legal guardian unable to understand the nature, scope, and possible consequences of the study.
- Pregnancy as ruled out by standard of care screening procedures.
- Individuals whose weight is less than 3.5 kg at the time of enrollment.
- Inability to comply with the protocol. ie. Children in whom it is deemed unsafe to have the extra blood draws, and children who are thought to be noncompliant with their medications.
Data sourced from ClinicalTrials.gov (NCT00848250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.