Oslo University Hospital
Oslo, Norway
NCT Number: NCT02306057
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.
Looking for future studies?
Notify Me1 month–10 year
All sexes
Observational
Oslo, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Diagnosis of Congenital heart defect in need of Fontan procedure -
Exclusion criteria
No parental consent
-
Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection
Routine catheterization before surgical procedure Total CavoPulmonary Connection
Surgical procedure Bidirectional CavoPulmonary Connection
Surgical procedure Total CavoPulmonary Connection
Time frame: Before and after surgery or catheterization
Change in interstitial colloid osmotic pressure
Oslo University Hospital
Other
Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03431480
Cardiovascular Abnormalities, Cardiovascular Diseases
Melbourne, Victoria, Australia
View Trial DetailsNCT02462434
Behavior, Behavioral Symptoms
Ann Arbor, Michigan, United States
View Trial DetailsNCT00027417
Cardiovascular Abnormalities, Cardiovascular Diseases
Seattle, Washington, United States
View Trial DetailsNCT04467671
Cardiovascular Abnormalities, Cardiovascular Diseases
Columbus, Ohio, United States
View Trial Details