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Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00263406
First Posted: December 8, 2005
Last Update Posted: December 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Ghent
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00263406     History of Changes
Other Study ID Numbers: 2002/055
First Submitted: December 4, 2005
First Posted: December 8, 2005
Last Update Posted: December 28, 2007
Last Verified: December 2007

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