Fluid Balance During Closure of Atrial Septal Defect
This study is currently recruiting participants.
Verified February 2013 by Oslo University Hospital
Sponsor:
Oslo University Hospital
Collaborator:
University of Bergen
Information provided by (Responsible Party):
Marianne Indrebo, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01757743
First received: December 21, 2012
Last updated: February 28, 2013
Last verified: February 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 21, 2012 | ||||||||
| Last Updated Date | February 28, 2013 | ||||||||
| Start Date ICMJE | February 2013 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Interstitial colloid osmotic pressure [ Time Frame: During surgery or interventional closure ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01757743 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Fluid Balance During Closure of Atrial Septal Defect | ||||||||
| Official Title ICMJE | Protein Distribution and Colloid Osmotic Pressure in Children With Volume and Pressure Loading Due to Congenital Heart Defects | ||||||||
| 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". |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Interstitial fluid Serum |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Children with Atrial Septal Defect scheduled for interventional closure with device or surgical repair |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | January 2017 | ||||||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 6 Months to 10 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01757743 | ||||||||
| Other Study ID Numbers ICMJE | 063.09 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Marianne Indrebo, Oslo University Hospital | ||||||||
| Study Sponsor ICMJE | Oslo University Hospital | ||||||||
| Collaborators ICMJE | University of Bergen | ||||||||
| Investigators ICMJE |
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| Information Provided By | Oslo University Hospital | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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