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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014