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Fluid Balance During Closure of Atrial Septal Defect

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Oslo University Hospital
Sponsor:
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Marianne Indrebo, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01757743
First received: December 21, 2012
Last updated: June 30, 2014
Last verified: June 2014

December 21, 2012
June 30, 2014
February 2013
January 2015   (final data collection date for primary outcome measure)
Interstitial colloid osmotic pressure [ Time Frame: During surgery or interventional closure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01757743 on ClinicalTrials.gov Archive Site
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Fluid Balance During Closure of Atrial Septal Defect
Protein Distribution and Colloid Osmotic Pressure in Children With Volume and Pressure Loading Due to Congenital Heart Defects

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".

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Interstitial fluid Serum

Probability Sample

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

  • Heart Defects,Congenital
  • Heart Septal Defects, Atrial
Not Provided
  • Interventional closure
    Interventional catheterization closure
  • Open Heart Surgery
    Surgery for Atrial septal defect
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
January 2017
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Renal failure,
  • liver failure,
  • coexisting cardiac malformations
Both
6 Months to 10 Years
No
Contact: Marianne M Indrebø, MD m.m.indrebo@medisin.uio.no
Contact: Gunnar Norgård, MD, PhD gunnar.norgard@ous-hf.no
Norway
 
NCT01757743
063.09
No
Marianne Indrebo, Oslo University Hospital
Oslo University Hospital
University of Bergen
Principal Investigator: Marianne M Indrebo, MD Oslo University Hospital
Oslo University Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP