University Hospital Ghent
Ghent, 9000, Belgium
Completed
NCT Number: NCT00263406
Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
Randomisation between postoperative administration of an ACE-inhibitor or not.
Completed
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Conditions
Age range
1 month–18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Administration of an ACE-inhibitor or not
DrugPrimary outcomes
-
Duration of the pleural drainage in the first two postoperative weeks
Sponsors and collaborators
Lead sponsor
University Hospital, Ghent
Other
Registry information
Important dates
- Study start
- 2002
- Study completion
- 2007
- First posted
- Dec 8, 2005
- Registry last updated
- Dec 28, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.