Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

• 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: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Gregory Fleming, Vanderbilt University Medical Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Congenital Heart Disease	Drug: Angiotensin Converting Enzyme Inhibitor; Other: No ACE Inhibitor	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects
• Study Start Date: September 2008
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: up to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Tennessee

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

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

More Information

• Responsible Party: Gregory Fleming, Assistant Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT00848250
• Other Study ID Numbers: 071078
• First Posted: February 20, 2009
• Results First Posted: July 26, 2017
• Last Update Posted: July 26, 2017
• Last Verified: June 2017

Keywords provided by Gregory Fleming, Vanderbilt University Medical Center:

Cardiopulmonary Bypass; ACE inhibitor; Pediatrics

Additional relevant MeSH terms:

Heart Diseases; Heart Defects, Congenital; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors; Protease Inhibitors; Molecular Mechanisms of Pharmacological Action