NCT01397526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 1, 2014

Status Verified

June 1, 2014

Enrollment Period

1.8 years

First QC Date

July 18, 2011

Last Update Submit

June 30, 2014

Conditions

Heart Defects, Congenital

Keywords

Congenital heart diseaseCardiopulmonary bypassCapillary leakColloid osmotic pressureChildren

Outcome Measures

Primary Outcomes (1)

  • Interstitial colloid osmotic pressure

    Before, during and after surgery

Eligibility Criteria

Age1 Day - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children scheduled for open heart surgery with the use of Cardiopulmonary Bypass at Oslo University Hospital

You may qualify if:

  • 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

You may not qualify if:

  • renal failure
  • liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0027, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Interstitial fluid Serum

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Gunnar Norgard, Prof. PhD

    Oslo University Hospital

    STUDY CHAIR

  • Ansgar Berg, Prof. PhD

    Haukeland University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cand.med

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 19, 2011

Study Start

July 1, 2011

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

July 1, 2014

Record last verified: 2014-06

Locations

NO(1)