Colloid Osmotic Pressure in Patients With Fontan Circulation | NCT02443662

Studies
Colloid Osmotic Pressure in Patients With Fontan Circulation

NCT02443662

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Apr 18, 2018Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Heart Defects, Congenital

Interventions

Catheterization

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Dec 2017Actual

Completion Date

Jan 2018Actual

First Submitted Date

May 4, 2015

First Submission Date that Met QC Criteria

May 11, 2015

First Posted Date

May 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2018

Last Update Posted Date

Apr 18, 2018Actual

Name	Class
University of Bergen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

12Actual

Name	Type	Description	Arm Group Labels	Other Names
Catheterization	Other	Routine catheterization during follow up.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interstitial colloid osmotic pressure		Ten years after completed Fontan surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fontan circulation after completed Fontan surgery.
Anesthesia during catheterization.

Exclusion Criteria:

No consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marianne Indrebø, MD	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		0027	Norway

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002404	Catheterization

Ancestor Terms

ID	Term
D013812	Therapeutics
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided