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Sponsored by: |
University Hospital, Ghent |
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Information provided by: | University Hospital, Ghent |
ClinicalTrials.gov Identifier: | NCT00263406 |
Randomisation between postoperative administration of an ACE-inhibitor or not.
Condition | Intervention | Phase |
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Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation |
Drug: Administration of an ACE-inhibitor or not |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation |
Estimated Enrollment: | 40 |
Study Start Date: | December 2002 |
Study Completion Date: | March 2007 |
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.
Ages Eligible for Study: | 1 Month to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2002/055 |
Study First Received: | December 4, 2005 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00263406 |
Health Authority: | Belgium: Institutional Review Board |