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Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Angiotensin Converting Enzyme Inhibitor
No ACE Inhibitor
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease focused on measuring Cardiopulmonary Bypass, ACE inhibitor, Pediatrics

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ACE inhibitor

No ACE inhibitor

Arm Description

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

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

Outcomes

Primary Outcome Measures

(PAI-1) Plasminogen Activator Inhibitor -1 Antigen
t-PA (Tissue-type Plasminogen Activator) Antigen

Secondary Outcome Measures

IL-6 (Interleukin-6)
IL-8 (Interleukin-8)
(MAP) Mean Arterial Blood Pressure
Postoperative Bleeding
Chest tube output at 4 and 24 hours after completion of surgery
Postoperative Renal Function
Acute kidney injury occurring

Full Information

First Posted
February 5, 2009
Last Updated
June 26, 2017
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00848250
Brief Title
Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children
Official Title
Effects of Angiotensin Converting Enzyme Inhibition During and After Cardiopulmonary Bypass in Infants and Children With Congenital Heart Defects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Cardiopulmonary Bypass, ACE inhibitor, Pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACE inhibitor
Arm Type
Experimental
Arm Description
Patients already on an ACE inhibitor will continue it until the day of surgery
Arm Title
No ACE inhibitor
Arm Type
Experimental
Arm Description
Patients on ACE inhibitors who are randomized to stop their ACE inhibitor 48 hours prior to surgery
Intervention Type
Drug
Intervention Name(s)
Angiotensin Converting Enzyme Inhibitor
Intervention Description
Patients randomized to this group will continue their current dose of ACE inhibitors until surgery
Intervention Type
Other
Intervention Name(s)
No ACE Inhibitor
Intervention Description
Patients randomized to this group will stop their ACE inhibitors 48 hours before surgery
Primary Outcome Measure Information:
Title
(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
Title
t-PA (Tissue-type Plasminogen Activator) Antigen
Time Frame
Baseline (prior to surgery) to postoperative day 1
Secondary Outcome Measure Information:
Title
IL-6 (Interleukin-6)
Time Frame
Baseline (pre-surgery) to postoperative day 1
Title
IL-8 (Interleukin-8)
Time Frame
Baseline (pre-surgery) to postoperative day 1
Title
(MAP) Mean Arterial Blood Pressure
Time Frame
Baseline (prior to surgery) to postoperative day 1
Title
Postoperative Bleeding
Description
Chest tube output at 4 and 24 hours after completion of surgery
Time Frame
24 hours
Title
Postoperative Renal Function
Description
Acute kidney injury occurring
Time Frame
Baseline (prior to surgery) to postoperative day 1

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory A Fleming, MD
Organizational Affiliation
Vanderbilt University Medical Center, Division of Pediatric Cardiology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mias Pretorius, MBChB, MSCI
Organizational Affiliation
Vanderbilt University Medical Center, Department of Anesthesiology
Official's Role
Study Director
Facility Information:
Facility Name
Monroe Carell Jr. Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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Angiotensin Converting Enzyme Inhibitors During Cardiopulmonary Bypass in Infants and Children

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