Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
This study has been completed.
Sponsor:
University Hospital, Ghent
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00263406
First received: December 4, 2005
Last updated: December 19, 2007
Last verified: December 2007
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 4, 2005 | ||||
| Last Updated Date | December 19, 2007 | ||||
| Start Date ICMJE | December 2002 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Duration of the pleural drainage in the first two postoperative weeks | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00263406 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation | ||||
| Official Title ICMJE | Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation | ||||
| Brief Summary | Randomisation between postoperative administration of an ACE-inhibitor or not. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation | ||||
| Intervention ICMJE | Drug: Administration of an ACE-inhibitor or not | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 1 Month to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00263406 | ||||
| Other Study ID Numbers ICMJE | 2002/055 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Hospital, Ghent | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Ghent | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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