Fluid Balance in Children Undergoing Fontan Surgery

University of Oslo (UIO)

Status: Completed

Conditions: Heart Defects, Congenital; Hypoplastic Left Heart Syndrome

Treatments: Procedure: Pre TCPC; Procedure: Pre BCPC; Procedure: BCPC surgery; Procedure: TCPC

Study type: Observational

Funder types: Other

Identifiers

NCT02306057

063.09b

Details and patient eligibility

About

This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the child end up with a univentricular heart with one-chamber circulation ( Fontan circulation). This project will evaluate if these children has increased micro vascular leakage before surgery due to their congenital heart defect. The project will also investigate if the edema formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and hypothermia is caused by capillary leakage of plasma protein.

The study hypothesis are

1. Edema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane.
2. The degree of micro vascular leakage in open-heart surgery is related to duration of CPB and hypothermia.
3. Fontan circulation cause peripheral edema related to elevated central venous pressure and is not caused by increased micro vascular leakage of plasma proteins.

Enrollment: 39 patients

Sex: All

Ages: 1 month to 10 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Diagnosis of Congenital heart defect in need of Fontan procedure -

Exclusion Criteria: No parental consent

Trial design

39 participants in 4 patient groups

Pre BCPC

Description:

Children undergoing catheterization before Bidirectional CavoPulmonary Connection (BCPC) procedure

Treatment:

Procedure: Pre BCPC

BCPC surgery

Description:

Children undergoing surgical BCPC procedure

Treatment:

Procedure: BCPC surgery

Pre TCPC

Description:

Children undergoing catheterization before Total CavoPulmonary Connection (TCPC )procedure

Treatment:

Procedure: Pre TCPC

TCPC surgery

Description:

Children undergoing surgical TCPC procedure

Treatment:

Procedure: TCPC