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Fluid Balance During Closure of Atrial Septal Defect

Protein Distribution and Colloid Osmotic Pressure in Children With Volume and Pressure Loading Due to Congenital Heart Defects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01757743
Enrollment
41
Registered
2012-12-31
Start date
2013-02-28
Completion date
2017-01-31
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Defects,Congenital, Heart Septal Defects, Atrial

Keywords

Heart Septal Defects, Atrial, Oedema formation

Brief summary

This project will evaluate fluid balance and oedema formation in children with the same congenital heart disease (Atrial Septal Defect) who will either go through heart surgery with the use of Cardio Pulmonary Bypass and hypothermia or through interventional catheterization. The investigators will measure interstitial colloid osmotic pressure, distribution of proteins and cytokines. The study hypothesis is that Oedema developed during heart surgery is caused by reduced colloid osmotic pressure gradient through the capillary membrane.

Interventions

None listed

Sponsors

University of Bergen
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to 10 Years
Healthy volunteers
No

Inclusion criteria

* The diagnosis of Atrial Septal Defect scheduled for closure * Informed consent

Exclusion criteria

* Renal failure, * liver failure, * coexisting cardiac malformations

Design outcomes

Primary

MeasureTime frame
Interstitial colloid osmotic pressureDuring surgery or interventional closure

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026