Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation

This study has been completed.

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00263406

Purpose

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

Condition	Intervention	Phase
Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation	Drug: Administration of an ACE-inhibitor or not	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Duration of the pleural drainage in the first two postoperative weeks

Estimated Enrollment:	40
Study Start Date:	December 2002
Study Completion Date:	March 2007

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.

Eligibility

Ages Eligible for Study:	1 Month to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263406

Locations

Belgium
University Hospital Ghent
Ghent, Belgium, 9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Guy Van Nooten, MD, PhD

University Hospital, Ghent

More Information

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

Study ID Numbers:	2002/055
Study First Received:	December 4, 2005
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00263406
Health Authority:	Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on January 16, 2009