Colloid Osmotic Pressure During Heart Surgery in Children

Heart Defects, Congenital Clinical Trial

Official title:

Colloid Osmotic Pressure During Heart Surgery in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01397526
• Other study ID #: 063.09 (REK)
• Secondary ID: 21443(NSD)
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: June 30, 2014
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 13 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interstitial colloid osmotic pressure		Before, during and after surgery	No