Colloid Osmotic Pressure During Heart Surgery in Children

This study has been completed.
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Marianne Indrebo, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01397526
First received: July 18, 2011
Last updated: June 30, 2014
Last verified: June 2014
  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 Oslo University Hospital:

Primary Outcome Measures:
  • Interstitial colloid osmotic pressure [ Time Frame: Before, during and after surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 13 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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)
Study First Received: July 18, 2011
Last Updated: June 30, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Keywords provided by 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

ClinicalTrials.gov processed this record on July 22, 2014