Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation

Treatments: Drug: Administration of an ACE-inhibitor or not

Study type: Interventional

Funder types: Other

Identifiers

NCT00263406

2002/055

Details and patient eligibility

About

Randomisation between postoperative administration of an ACE-inhibitor or not.

Full 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.

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)