Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT00263406
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 51
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation	Drug: Administration of an ACE-inhibitor or not	Phase 2

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.

Study Design

• Study Type: Interventional
• 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
• Study Start Date: Dec 1, 2002
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

Primary Outcome Measures

1. Duration of the pleural drainage in the first two postoperative weeks []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Guy Van Nooten, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website of the University Hospital Ghent

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00263406
• Other Study ID Numbers: 2002/055
• First Posted: Dec 8, 2005
• Last Update Posted: Dec 28, 2007
• Last Verified: Dec 1, 2007

• Additional relevant MeSH terms: Univentricular Heart; Angiotensin-Converting Enzyme Inhibitors

Study Results

No Results Posted as of Dec 28, 2007