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Colloid Osmotic Pressure During Heart Surgery in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01397526
First Posted: July 19, 2011
Last Update Posted: July 1, 2014
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:
Haukeland University Hospital
Information provided by (Responsible Party):
Marianne Indrebo, Oslo University Hospital
  Purpose
Clinical oedema is seen after open heart surgery with the use of cardiopulmonary bypass and hypothermia in children. The oedema formation is due to increased fluid transport from blood to tissue. This transcapillary fluid transport is dependent on differences in interstitial and plasma colloid osmotic pressure. The purpose of this investigation is to evaluate changes in interstitial colloid osmotic pressure before, under and after the use of cardiopulmonary bypass in children. The study hypothesis is that oedema developed during cardiopulmonary bypass and hypothermia is caused by increased micro vascular protein leakage and reduced colloid osmotic pressure gradient through the capillary membrane.

Condition
Heart Defects, Congenital

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Colloid Osmotic Pressure During Heart Surgery in Children

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: Before, during and after surgery ]

Biospecimen Retention:   Samples Without DNA
Interstitial fluid Serum

Enrollment: 9
Study Start Date: July 2011
Study Completion Date: December 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children scheduled for open heart surgery with the use of Cardiopulmonary Bypass at Oslo University Hospital
Criteria

Inclusion Criteria:

  • The diagnosis of a congenital heart defect
  • scheduled for open heart surgery with the use of cardiopulmonary bypass
  • under 13 year of age
  • informed consent obtained from the parents

Exclusion Criteria:

  • renal failure
  • liver failure
  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): NCT01397526


Locations
Norway
Oslo University Hospital
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
Haukeland University Hospital
Investigators
Study Chair: Gunnar Norgard, Prof. PhD Oslo University Hospital
Study Director: Ansgar Berg, Prof. PhD Haukeland University Hospital
  More Information

Responsible Party: Marianne Indrebo, Cand.med, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01397526     History of Changes
Other Study ID Numbers: 063.09 (REK)
21443(NSD) ( Other Identifier: Norwegian Social Science Data Sevices )
First Submitted: July 18, 2011
First Posted: July 19, 2011
Last Update Posted: July 1, 2014
Last Verified: June 2014

Keywords provided by Marianne Indrebo, Oslo University Hospital:
Congenital heart disease
Cardiopulmonary bypass
Capillary leak
Colloid osmotic pressure
Children

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