Colloid Osmotic Pressure in Patients With Fontan Circulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02443662
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : April 18, 2018
University of Bergen
Information provided by (Responsible Party):
Marianne Indrebo, Oslo University Hospital

Brief Summary:
Children born with univentricular heart will go through step surgery and end up with a Fontan circulation. A circulation with cause problems with body fluid balance.This project will evaluate changes in interstitial colloid osmotic pressure in patients 10 year after completion of a three step Fontan surgery. This project will evaluate whether increased micro vascular leakage and change in interstitial colloid osmotic pressure are present in patients after ten years with a Fontan circulation.

Condition or disease Intervention/treatment
Heart Defects, Congenital Other: Catheterization

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Interstitial Colloid Osmotic Pressure in Children With Fontan Circulation After Fontan Surgery
Study Start Date : September 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: Catheterization
    Routine catheterization during follow up.

Primary Outcome Measures :
  1. Interstitial colloid osmotic pressure [ Time Frame: Ten years after completed Fontan surgery ]

Biospecimen Retention:   Samples Without DNA
Interstitial fluid. Serum

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children who will have a cathererization during their routine check up 10 years after completion of Fontan surgery.

Inclusion Criteria:

  • Fontan circulation after completed Fontan surgery.
  • Anesthesia during catheterization.

Exclusion Criteria:

  • No consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02443662

Oslo University Hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
University of Bergen
Principal Investigator: Marianne Indrebø, MD Oslo University Hospital

Responsible Party: Marianne Indrebo, MD, Oslo University Hospital Identifier: NCT02443662     History of Changes
Other Study ID Numbers: 063.09f
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases