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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02306057

Enrollment

Registered

2014-12-03

Start date

2014-11-30

Completion date

2017-04-30

Last updated

2017-04-11

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

Conditions

Heart Defects, Congenital, Hypoplastic Left Heart Syndrome

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.

Interventions

PROCEDUREPre BCPC

Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection

PROCEDUREPre TCPC

Routine catheterization before surgical procedure Total CavoPulmonary Connection

PROCEDUREBCPC surgery

Surgical procedure Bidirectional CavoPulmonary Connection

PROCEDURETCPC

Surgical procedure Total CavoPulmonary Connection

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 10 Years

Healthy volunteers

Inclusion criteria

Diagnosis of Congenital heart defect in need of Fontan procedure -

Exclusion criteria

No parental consent \-

Design outcomes

Primary

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

Countries

Norway

Outcome results

None listed

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