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Fluid Balance During Closure of Atrial Septal Defect

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01757743
First Posted: December 31, 2012
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Marianne Indrebo, Oslo University Hospital
  Purpose
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".

Condition
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 Marianne Indrebo, Oslo University Hospital:

Primary Outcome Measures:
  • Interstitial colloid osmotic pressure [ Time Frame: During surgery or interventional closure ]

Biospecimen Retention:   Samples Without DNA
Interstitial fluid Serum

Enrollment: 41
Study Start Date: February 2013
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Interventional closure
Interventional catheterization closure
Open Heart Surgery
Surgery for Atrial septal defect

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with Atrial Septal Defect scheduled for interventional closure with device or surgical repair
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757743


Locations
Norway
Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
University of Bergen
Investigators
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
First Submitted: December 21, 2012
First Posted: December 31, 2012
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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