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NCT01757743 Clinical Trial

Fluid Balance During Closure of Atrial Septal Defect

Heart Septal Defects, Atrial Clinical Trial

Official title:
Protein Distribution and Colloid Osmotic Pressure in Children With Volume and Pressure Loading Due to Congenital Heart Defects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01757743
Other study ID # 063.09
Secondary ID
Status Completed
Phase N/A
First received December 21, 2012
Last updated April 8, 2017
Start date February 2013
Est. completion date January 2017

Study information
Verified date April 2017
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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".

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 6 Months to 10 Years
Eligibility Inclusion Criteria:

- The diagnosis of Atrial Septal Defect scheduled for closure

- Informed consent

Exclusion Criteria:

- Renal failure,

- liver failure,

- coexisting cardiac malformations

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (2)
Lead Sponsor Collaborator
Oslo University Hospital University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Interstitial colloid osmotic pressure During surgery or interventional closure
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