Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00263406

Enrollment

Registered

2005-12-08

Start date

2002-12-31

Completion date

2007-03-31

Last updated

2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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.

Interventions

DRUGAdministration of an ACE-inhibitor or not

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Duration of the pleural drainage in the first two postoperative weeks	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026