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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02306057
Other study ID # 063.09b
Secondary ID
Status Completed
Phase N/A
First received October 31, 2014
Last updated April 8, 2017
Start date November 2014
Est. completion date April 2017

Study information

Verified date April 2017
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date April 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 1 Month to 10 Years
Eligibility Inclusion Criteria: Diagnosis of Congenital heart defect in need of Fontan procedure -

Exclusion Criteria: No parental consent

Study Design


Intervention

Procedure:
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

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (2)

Lead Sponsor Collaborator
Oslo University Hospital University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Interstitial colloid osmotic pressure Change in interstitial colloid osmotic pressure Before and after surgery or catheterization
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