Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia
Sponsor study identifier
observational
39
1 country
1
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2017
Actual (reported)Study Completion
April 2017
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 31, 2014
Actual (reported)November 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 3, 2014
Actual (reported)March 2017
Actual (reported)April 2017
Actual (reported)Interstitial colloid osmotic pressure
Change in interstitial colloid osmotic pressure
Before and after surgery or catheterization
Children undergoing catheterization before Bidirectional CavoPulmonary Connection (BCPC) procedure
Children undergoing surgical BCPC procedure
Children undergoing catheterization before Total CavoPulmonary Connection (TCPC )procedure
Children undergoing surgical TCPC procedure
Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection
Routine catheterization before surgical procedure Total CavoPulmonary Connection
Children with congenital heart defect scheduled for Fontan surgery
Contact the study team to confirm eligibility.
Oslo University Hospital
Oslo, Norway
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.
Interstitial fluid Serum
Marianne Indrebø, MD
Oslo University Hospital
39 participants (actual enrollment reported by the registry).
First Submitted
October 31, 2014
First Posted
December 3, 2014
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Livet Skal Leves (A Life to Live)
Surgical procedure Bidirectional CavoPulmonary Connection
Surgical procedure Total CavoPulmonary Connection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Primary Completion
March 2017
Actual (reported)Study Completion
April 2017
Actual (reported)Last Updated
April 11, 2017
Record last verified: 2017-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: