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CompletedNCT01757743Updated Apr 11, 2017

Fluid Balance During Closure of Atrial Septal Defect

An observational study in Heart Defects,Congenital and Heart Septal Defects, Atrial, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 6 Months to 10 Years. Per ClinicalTrials.gov, last updated 2017-04-11.

Sponsored by Oslo University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
41
Ages
6 Months to 10 Years
Sex
All
01

Study 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".

02

Conditions studied

  • Heart Defects,Congenital
  • Heart Septal Defects, Atrial

Keywords

  • Heart Septal Defects, Atrial
  • Oedema formation
03

In context

Heart Septal Defects

82 studies on the registry are indexed under Heart Septal Defects; 9 are open to participants now.

This study's enrollment of 41 is below the median of 75 across 24 observational studies indexed under Heart Septal Defects.

Browse Heart Septal Defects studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children with Atrial Septal Defect scheduled for interventional closure with device or surgical repair

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Renal failure,
  • liver failure,
  • coexisting cardiac malformations
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
41 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Interventional closure

    Interventional catheterization closure

  • Open Heart Surgery

    Surgery for Atrial septal defect

06

What researchers measure

Primary outcomes

  1. Interstitial colloid osmotic pressure

    Time frame: During surgery or interventional closure

07

Study locations

1 site
  • Oslo University Hospital
    Oslo, Norway
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01757743
Lead sponsor
Oslo University Hospital
Collaborators
University of Bergen
Responsible party
Marianne Indrebo (MD Research fellow, Oslo University Hospital) — Principal investigator
First posted
Dec 31, 2012
Start date
Feb 2013
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Apr 11, 2017

Study contacts

Marianne M Indrebo, MD
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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