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OpenTrials
Completed

NCT Number: NCT02306057

Fluid Balance in Children Undergoing Fontan Surgery

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.

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Key information

Age range

1 month–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, Norway

Who can participate

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

-

Treatment and study plan

Pre BCPC

Procedure

Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection

Pre TCPC

Procedure

Routine catheterization before surgical procedure Total CavoPulmonary Connection

BCPC surgery

Procedure

Surgical procedure Bidirectional CavoPulmonary Connection

TCPC

Procedure

Surgical procedure Total CavoPulmonary Connection

Primary outcomes

  1. Interstitial colloid osmotic pressure

    Time frame: Before and after surgery or catheterization

    Change in interstitial colloid osmotic pressure

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • University of Bergen

Registry information

Official study title

Interstitial Colloid Osmotic Pressure in Children With Congenital Heart Defect Preparing for Fontan Surgery Undergoing Preoperative Catheterization and Surgery in General Anesthesia

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2014
Registry last updated
Apr 11, 2017

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.

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