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Completed

NCT Number: NCT02443662

Colloid Osmotic Pressure in Patients With Fontan Circulation

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.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0027, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No consent

Treatment and study plan

Catheterization

Other

Routine catheterization during follow up.

Primary outcomes

  1. Interstitial colloid osmotic pressure

    Time frame: Ten years after completed Fontan surgery

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Bergen

Registry information

Official study title

Interstitial Colloid Osmotic Pressure in Children With Fontan Circulation After Fontan Surgery

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 14, 2015
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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