Fluid Balance in Children Undergoing Fontan Surgery

Heart Defects, Congenital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306057
• Other study ID #: 063.09b
• Status: Completed
• Phase: N/A
• First received: October 31, 2014
• Last updated: April 8, 2017
• Start date: November 2014
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 10 Years

Eligibility

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

Exclusion Criteria: No parental consent

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Hypoplastic Left Heart Syndrome

Intervention

Procedure:
• Pre BCPC
Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection
• Pre TCPC
Routine catheterization before surgical procedure Total CavoPulmonary Connection
• BCPC surgery
Surgical procedure Bidirectional CavoPulmonary Connection
• TCPC
Surgical procedure Total CavoPulmonary Connection

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interstitial colloid osmotic pressure	Change in interstitial colloid osmotic pressure	Before and after surgery or catheterization