Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-25 @ 4:02 PM
Study NCT ID:
NCT02306057
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2014-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluid Balance in Children Undergoing Fontan Surgery
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: