Skip to main content
OpenTrials
Completed

NCT Number: NCT00848250

Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Angiotensin Converting Enzyme Inhibitor

Drug

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

No ACE Inhibitor

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 20, 2009
Registry last updated
Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.