Fluid Balance in Children Undergoing Fontan Surgery

April 8, 2017 updated by: Marianne Indrebo, Oslo University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children with congenital heart defect scheduled for Fontan surgery

Description

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

Exclusion Criteria: No parental consent

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre BCPC
Children undergoing catheterization before Bidirectional CavoPulmonary Connection (BCPC) procedure
Procedure: Pre BCPC
Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection
BCPC surgery
Children undergoing surgical BCPC procedure
Procedure: BCPC surgery
Surgical procedure Bidirectional CavoPulmonary Connection
Pre TCPC
Children undergoing catheterization before Total CavoPulmonary Connection (TCPC )procedure
Procedure: Pre TCPC
Routine catheterization before surgical procedure Total CavoPulmonary Connection
TCPC surgery
Children undergoing surgical TCPC procedure
Procedure: TCPC
Surgical procedure Total CavoPulmonary Connection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Bergen

Investigators

  • Principal Investigator: Marianne Indrebø, MD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 28, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 8, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 063.09b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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