NCT01757743

Brief Summary

This project will evaluate fluid balance and oedema formation in children with the same congenital heart disease (Atrial Septal Defect) who will either go through heart surgery with the use of Cardio Pulmonary Bypass and hypothermia or through interventional catheterization. The investigators will measure interstitial colloid osmotic pressure, distribution of proteins and cytokines. The study hypothesis is that "Oedema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane".

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 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

December 21, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 31, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

3.9 years

First QC Date

December 21, 2012

Last Update Submit

April 8, 2017

Conditions

Heart Defects,CongenitalHeart Septal Defects, Atrial

Keywords

Heart Septal Defects, AtrialOedema formation

Outcome Measures

Primary Outcomes (1)

  • Interstitial colloid osmotic pressure

    During surgery or interventional closure

Study Arms (2)

Interventional closure

Interventional catheterization closure

Open Heart Surgery

Surgery for Atrial septal defect

Eligibility Criteria

Age6 Months - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with Atrial Septal Defect scheduled for interventional closure with device or surgical repair

You may qualify if:

  • The diagnosis of Atrial Septal Defect scheduled for closure
  • Informed consent

You may not qualify if:

  • Renal failure,
  • liver failure,
  • coexisting cardiac malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Interstitial fluid Serum

MeSH Terms

Conditions

Heart Defects, CongenitalHeart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Septal Defects

Study Officials

  • Marianne M Indrebo, 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 Research fellow

Study Record Dates

First Submitted

December 21, 2012

First Posted

December 31, 2012

Study Start

February 1, 2013

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

NO(1)