NCT02443662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

May 4, 2015

Last Update Submit

April 17, 2018

Conditions

Heart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

  • Interstitial colloid osmotic pressure

    Ten years after completed Fontan surgery

Interventions

CatheterizationOTHER

Routine catheterization during follow up.

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children who will have a cathererization during their routine check up 10 years after completion of Fontan surgery.

You may qualify if:

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

You may not qualify if:

  • No consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0027, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Interstitial fluid. Serum

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Catheterization

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Marianne Indrebø, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 14, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

April 18, 2018

Record last verified: 2018-04

Locations

NO(1)