NCT00263406CompletedPhase 2
Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
University Hospital, Ghent2 sites in 1 country40 target enrollmentStarted: December 2002Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Duration of the pleural drainage in the first two postoperative weeks
Study Overview
Brief Summary
Randomisation between postoperative administration of an ACE-inhibitor or not.
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
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 18 Years (Child, Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Duration of the pleural drainage in the first two postoperative weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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