Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation Clinical Trial
Official title:
Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation
| Verified date | December 2007 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Interventional |
Randomisation between postoperative administration of an ACE-inhibitor or not.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | March 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Month to 18 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Ghent | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Duration of the pleural drainage in the first two postoperative weeks |