- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01044641
Measurement of Colloid Osmotic Pressure in Plasma and Interstitial Fluid in Children
July 3, 2014 updated by: Haukeland University Hospital
The purpose of this study is to identify normal values of colloid osmotic pressure in interstitial fluid and plasma in healthy children between 2 and 10 years.
Study Overview
Status
Completed
Conditions
Detailed Description
Measurements of colloid osmotic pressure (COP) by sampling of interstitial fluid from subcutaneous tissue and plasma are well documented in animal models and human adult studies.
COP plays a major role in transcapillary fluid balance and is valuable in fluid therapy planning in critically ill patients.
There are no data regarding interstitial fluid COP values in neither sick nor healthy children.
Sampling of interstitial fluid by the wick method in children who is under general anaesthesia (ear-nose-throat operations) gives the opportunity to identify normal COP values in this age group.
Study Type
Observational
Enrollment (Actual)
99
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bergen, Norway, 5021
- Haukeland University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Secondary care clinic (ENT)
Description
Inclusion Criteria:
- Children from 2 to 10 years
Exclusion Criteria:
- Medication
- Ongoing illness
- Syndromes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Colloid osmotic pressure
Time Frame: 60 minuttes after wick insertion
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60 minuttes after wick insertion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hans Joergen T Guthe, MD, Hanukeland University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
January 6, 2010
First Submitted That Met QC Criteria
January 7, 2010
First Posted (Estimate)
January 8, 2010
Study Record Updates
Last Update Posted (Estimate)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 3, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 065816
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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