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NCT02443662 Clinical Trial

Colloid Osmotic Pressure in Patients With Fontan Circulation

Heart Defects, Congenital Clinical Trial

Official title:
Interstitial Colloid Osmotic Pressure in Children With Fontan Circulation After Fontan Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02443662
Other study ID # 063.09f
Secondary ID
Status Completed
Phase
First received May 4, 2015
Last updated April 17, 2018
Start date September 2015
Est. completion date January 2018

Study information
Verified date April 2018
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date January 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria:

- Fontan circulation after completed Fontan surgery.

- Anesthesia during catheterization.

Exclusion Criteria:

- No consent

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Catheterization
Routine catheterization during follow up.

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 Ten years after completed Fontan surgery
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