Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00263406
First received: December 4, 2005
Last updated: December 19, 2007
Last verified: December 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014