NCT02306057

Fluid Balance in Children Undergoing Fontan Surgery

Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 1 Month – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Defects, Congenital
• Hypoplastic Left Heart Syndrome

Interventions

Type	Name	Description
PROCEDURE	Pre BCPC	Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection
PROCEDURE	Pre TCPC	Routine catheterization before surgical procedure Total CavoPulmonary Connection
PROCEDURE	BCPC surgery	Surgical procedure Bidirectional CavoPulmonary Connection
PROCEDURE	TCPC	Surgical procedure Total CavoPulmonary Connection

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-03-01
• Completion: 2017-04-01
• First posted: 2014-12-03
• Last updated: 2017-04-11

Locations

1 site across 1 country: Norway