Fluid Balance in Children Undergoing Fontan Surgery

Completed

• Conditions: Hypoplastic Left Heart Syndrome; Heart Defects, Congenital
• Interventions: Procedure: BCPC surgery; Procedure: TCPC; Procedure: Pre BCPC; Procedure: Pre TCPC

• Registration Number: NCT02306057
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-31
• Study Start: 2014-11
• Study First Submitted QC: 2014-11-28
• Study First Posted: 2014-12-03
• Primary Completion: 2017-03
• Status Verified: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-08
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Diagnosis of Congenital heart defect in need of Fontan procedure -

Exclusion Criteria

No parental consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BCPC surgery	BCPC surgery	Children undergoing surgical BCPC procedure
TCPC surgery	TCPC	Children undergoing surgical TCPC procedure
Pre BCPC	Pre BCPC	Children undergoing catheterization before Bidirectional CavoPulmonary Connection (BCPC) procedure
Pre TCPC	Pre TCPC	Children undergoing catheterization before Total CavoPulmonary Connection (TCPC )procedure

Primary Outcome Measures

Name	Time	Method
Interstitial colloid osmotic pressure	Before and after surgery or catheterization	Change in interstitial colloid osmotic pressure

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway