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Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation

Primary Purpose

Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Administration of an ACE-inhibitor or not
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All consecutive children with a univentricular heart disease undergoing elective surgery for creation of a Fontan circulation Parents have agreed with the study after informed consent Exclusion Criteria: Urgent / Emergent surgery Preoperative use of an ACE-inhibitor

Sites / Locations

  • University Hospital Ghent

Outcomes

Primary Outcome Measures

Duration of the pleural drainage in the first two postoperative weeks

Secondary Outcome Measures

Full Information

First Posted
December 4, 2005
Last Updated
December 19, 2007
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00263406
Brief Title
Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
Official Title
Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomisation between postoperative administration of an ACE-inhibitor or not.
Detailed Description
Children that are undergoing elective surgery for the creation of a Fontan circulation will be randomised to postoperative administration of an ACE-inhibitor or not. Determination of aldosteron, renine and ADH in serum preoperatively and 1h, 12h and 5 days postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Administration of an ACE-inhibitor or not
Primary Outcome Measure Information:
Title
Duration of the pleural drainage in the first two postoperative weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All consecutive children with a univentricular heart disease undergoing elective surgery for creation of a Fontan circulation Parents have agreed with the study after informed consent Exclusion Criteria: Urgent / Emergent surgery Preoperative use of an ACE-inhibitor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Van Nooten, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent

Learn more about this trial

Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation

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