Colloid Osmotic Pressure During Heart Surgery in Children

NCT ID: NCT01397526

Last Updated: 2014-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Defects, Congenital

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marianne Indrebo

Cand.med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gunnar Norgard, Prof. PhD

Role: STUDY_CHAIR

Oslo University Hospital

Ansgar Berg, Prof. PhD

Role: STUDY_DIRECTOR

Haukeland University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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21443(NSD)

Identifier Type: OTHER

Identifier Source: secondary_id

063.09 (REK)

Identifier Type: -

Identifier Source: org_study_id

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