Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2007-03-31

Brief Summary

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Randomisation between postoperative administration of an ACE-inhibitor or not.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Administration of an ACE-inhibitor or not

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Guy Van Nooten, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2002/055

Identifier Type: -

Identifier Source: org_study_id