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Colloid Osmotic Pressure During Heart Surgery in Children

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ClinicalTrials.gov Identifier: NCT01397526
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : July 1, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Heart Defects, Congenital

Study Design

Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Colloid Osmotic Pressure During Heart Surgery in Children
Study Start Date : July 2011
Primary Completion Date : May 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Interstitial colloid osmotic pressure [ Time Frame: Before, during and after surgery ]

Biospecimen Retention:   Samples Without DNA
Interstitial fluid Serum

Eligibility Criteria

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 Posted: July 19, 2011    Key Record Dates
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