Study Results
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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COMPLETED
39 participants
OBSERVATIONAL
2014-11-30
2017-04-30
Brief Summary
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The study hypothesis are
1. Edema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane.
2. The degree of micro vascular leakage in open-heart surgery is related to duration of CPB and hypothermia.
3. Fontan circulation cause peripheral edema related to elevated central venous pressure and is not caused by increased micro vascular leakage of plasma proteins.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Pre BCPC
Children undergoing catheterization before Bidirectional CavoPulmonary Connection (BCPC) procedure
Pre BCPC
Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection
BCPC surgery
Children undergoing surgical BCPC procedure
BCPC surgery
Surgical procedure Bidirectional CavoPulmonary Connection
Pre TCPC
Children undergoing catheterization before Total CavoPulmonary Connection (TCPC )procedure
Pre TCPC
Routine catheterization before surgical procedure Total CavoPulmonary Connection
TCPC surgery
Children undergoing surgical TCPC procedure
TCPC
Surgical procedure Total CavoPulmonary Connection
Interventions
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Pre BCPC
Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection
Pre TCPC
Routine catheterization before surgical procedure Total CavoPulmonary Connection
BCPC surgery
Surgical procedure Bidirectional CavoPulmonary Connection
TCPC
Surgical procedure Total CavoPulmonary Connection
Eligibility Criteria
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Exclusion Criteria
1 Month
10 Years
ALL
No
Sponsors
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University of Bergen
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Marianne Indrebo
MD Research fellow
Principal Investigators
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Marianne Indrebø, MD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Oslo University Hospital
Oslo, , Norway
Countries
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References
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Indrebo M, Berg A, Holmstrom H, Seem E, Guthe HJT, Wiig H, Norgard G. Fluid accumulation in the staged Fontan procedure: the impact of colloid osmotic pressures. Interact Cardiovasc Thorac Surg. 2019 Apr 1;28(4):510-517. doi: 10.1093/icvts/ivy298.
Other Identifiers
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063.09b
Identifier Type: -
Identifier Source: org_study_id
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