Colloid Osmotic Pressure During Heart Surgery in Children

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.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases

Age range

1 day–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0027, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Interstitial colloid osmotic pressure

Time frame: Before, during and after surgery

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

Haukeland University Hospital

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jul 19, 2011
Registry last updated: Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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