Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

NCT00848250 | Completed Results

• 1 other identifier: 071078
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Cardiopulmonary Bypass; ACE inhibitor; Pediatrics

Outcome Measures

Primary Outcomes (2)

• (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 Outcomes (5)

• 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

  24 hours

• Postoperative Renal Function

  Baseline (prior to surgery) to postoperative day 1

Study Arms (2)

ACE inhibitor

EXPERIMENTAL

Patients already on an ACE inhibitor will continue it until the day of surgery

Drug: Angiotensin Converting Enzyme Inhibitor

No ACE inhibitor

EXPERIMENTAL

Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery

Other: No ACE Inhibitor

Interventions

Angiotensin Converting Enzyme Inhibitor DRUG

Patients randomized to this group will continue their current dose of ACE inhibitors until surgery

ACE inhibitor

No ACE Inhibitor OTHER

Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery

No ACE inhibitor

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

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.

Results Point of Contact

• Title: Mias Pretorius
• Organization: Vanderbilt University Medical Center

mias.pretorius@vanderbilt.edu

615-8757402

Study Officials

• Gregory A Fleming, MD

  Vanderbilt University Medical Center, Division of Pediatric Cardiology

  PRINCIPAL INVESTIGATOR

• Mias Pretorius, MBChB, MSCI

  Vanderbilt University Medical Center, Department of Anesthesiology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 20, 2009
• Study Start: September 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 26, 2017
• Results First Posted: July 26, 2017

Record last verified: 2017-06

Locations

US (1)