Fluid Balance During Closure of Atrial Septal Defect

Completed

• Conditions: Heart Septal Defects, Atrial; Heart Defects,Congenital

• Registration Number: NCT01757743
• Lead Sponsor: Oslo University Hospital

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".

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2012-12-28
• Study First Posted: 2012-12-31
• Study Start: 2013-02
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-08
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interstitial colloid osmotic pressure	During surgery or interventional closure

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway