Colloid Osmotic Pressure During Heart Surgery in Children

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01397526

Enrollment

Registered

2011-07-19

Start date

2011-07-31

Completion date

2013-12-31

Last updated

2014-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Defects, Congenital

Keywords

Congenital heart disease, Cardiopulmonary bypass, Capillary leak, Colloid osmotic pressure, Children

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 13 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Interstitial colloid osmotic pressure	Before, during and after surgery

Countries

Norway

Outcome results