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Fluid Balance in Children Undergoing Fontan Surgery

NCT02306057 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2017-04-11

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Pre BCPC

Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection

PROCEDURE

Pre TCPC

Routine catheterization before surgical procedure Total CavoPulmonary Connection

PROCEDURE

BCPC surgery

Surgical procedure Bidirectional CavoPulmonary Connection

PROCEDURE

TCPC

Surgical procedure Total CavoPulmonary Connection

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Marianne Indrebø, MD · Oslo University Hospital

Eligibility

Min Age
1 Month
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-03-31
Completion
2017-04-30

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02306057 on ClinicalTrials.gov