Fluid Balance in Children Undergoing Fontan Surgery
Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia
1 other identifier
observational
39
1 country
1
Brief Summary
This project will evaluate fluid balance and edema formation in children with congenital heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the child end up with a univentricular heart with one-chamber circulation ( Fontan circulation). This project will evaluate if these children has increased micro vascular leakage before surgery due to their congenital heart defect. The project will also investigate if the edema formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and hypothermia is caused by capillary leakage of plasma protein. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedApril 11, 2017
April 1, 2017
2.3 years
October 31, 2014
April 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Interstitial colloid osmotic pressure
Change in interstitial colloid osmotic pressure
Before and after surgery or catheterization
Study Arms (4)
Pre BCPC
Children undergoing catheterization before Bidirectional CavoPulmonary Connection (BCPC) procedure
BCPC surgery
Children undergoing surgical BCPC procedure
Pre TCPC
Children undergoing catheterization before Total CavoPulmonary Connection (TCPC )procedure
TCPC surgery
Children undergoing surgical TCPC procedure
Interventions
Eligibility Criteria
Children with congenital heart defect scheduled for Fontan surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- University of Bergencollaborator
Study Sites (1)
Oslo University Hospital
Oslo, Norway
Related Publications (1)
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.
PMID: 30371784DERIVED
Biospecimen
Interstitial fluid Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marianne Indrebø, MD
Oslo University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Research fellow
Study Record Dates
First Submitted
October 31, 2014
First Posted
December 3, 2014
Study Start
November 1, 2014
Primary Completion
March 1, 2017
Study Completion
April 1, 2017
Last Updated
April 11, 2017
Record last verified: 2017-04