Fluid Balance During Closure of Atrial Septal Defect

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Oslo University Hospital
University of Bergen
Information provided by (Responsible Party):
Marianne Indrebo, Oslo University Hospital
ClinicalTrials.gov Identifier:
First received: December 21, 2012
Last updated: March 31, 2016
Last verified: March 2016
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".

Heart Defects,Congenital
Heart Septal Defects, Atrial

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Protein Distribution and Colloid Osmotic Pressure in Children With Volume and Pressure Loading Due to Congenital Heart Defects

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Interstitial colloid osmotic pressure [ Time Frame: During surgery or interventional closure ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Interstitial fluid Serum

Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Interventional closure
Interventional catheterization closure
Open Heart Surgery
Surgery for Atrial septal defect


Ages Eligible for Study:   6 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with Atrial Septal Defect scheduled for interventional closure with device or surgical repair

Inclusion Criteria:

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

Exclusion Criteria:

  • Renal failure,
  • liver failure,
  • coexisting cardiac malformations
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757743

Contact: Marianne M Indrebø, MD m.m.indrebo@medisin.uio.no
Contact: Gunnar Norgård, MD, PhD gunnar.norgard@ous-hf.no

Oslo University Hospital Recruiting
Oslo, Norway
Contact: Marianne M Indrebø, MD       maindr@ous-hf.no   
Principal Investigator: Marianne M Indrebø, MD         
Sponsors and Collaborators
Oslo University Hospital
University of Bergen
Principal Investigator: Marianne M Indrebo, MD Oslo University Hospital
  More Information

Responsible Party: Marianne Indrebo, MD Research fellow, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01757743     History of Changes
Other Study ID Numbers: 063.09 
Study First Received: December 21, 2012
Last Updated: March 31, 2016
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by Oslo University Hospital:
Heart Septal Defects, Atrial
Oedema formation

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Heart Septal Defects
Heart Septal Defects, Atrial
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on May 24, 2016