Colloid Osmotic Pressure in Patients With Fontan Circulation

NCT ID: NCT02443662

Last Updated: 2018-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Defects, Congenital

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Catheterization

Routine catheterization during follow up.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No consent
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bergen

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marianne Indrebo

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marianne Indrebø, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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063.09f

Identifier Type: -

Identifier Source: org_study_id

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