Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Drug: Angiotensin Converting Enzyme Inhibitor; Other: No ACE Inhibitor

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Monroe Carell Jr. Children's Hospital at Vanderbilt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACE inhibitor; Patients already on an ACE inhibitor will continue it until the day of surgery	Drug: Angiotensin Converting Enzyme Inhibitor; Patients randomized to this group will continue their current dose of ACE inhibitors until surgery
Experimental: No ACE inhibitor; Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery	Other: No ACE Inhibitor; Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(PAI-1) Plasminogen Activator Inhibitor -1 Antigen	Baseline (prior to surgery), On CPB for 30 minutes, At completion of CPB, and postoperative day 1 (at 8:00AM)postoperative day 1
t-PA (Tissue-type Plasminogen Activator) Antigen	Baseline (prior to surgery) to postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL-6 (Interleukin-6)		Baseline (pre-surgery) to postoperative day 1
IL-8 (Interleukin-8)		Baseline (pre-surgery) to postoperative day 1
(MAP) Mean Arterial Blood Pressure		Baseline (prior to surgery) to postoperative day 1
Postoperative Bleeding	Chest tube output at 4 and 24 hours after completion of surgery	24 hours
Postoperative Renal Function	Acute kidney injury occurring	Baseline (prior to surgery) to postoperative day 1

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Gregory A Fleming, MD, Vanderbilt University Medical Center, Division of Pediatric Cardiology; Study Director: Mias Pretorius, MBChB, MSCI, Vanderbilt University Medical Center, Department of Anesthesiology

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: February 5, 2009
• First Submitted That Met QC Criteria: February 19, 2009
• First Posted (Estimate): February 20, 2009

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Pediatrics; Cardiopulmonary Bypass; ACE inhibitor
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Angiotensin-Converting Enzyme Inhibitors
• Other Study ID Numbers: 071078