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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01044641
Other study ID # 065816
Secondary ID
Status Completed
Phase N/A
First received January 6, 2010
Last updated July 3, 2014
Start date December 2009
Est. completion date May 2013

Study information

Verified date July 2014
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 10 Years
Eligibility Inclusion Criteria:

- Children from 2 to 10 years

Exclusion Criteria:

- Medication

- Ongoing illness

- Syndromes

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Haukeland University Hospital Bergen

Sponsors (1)

Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Colloid osmotic pressure 60 minuttes after wick insertion No
See also
  Status Clinical Trial Phase
Completed NCT01044940 - Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma in Healthy and Sick Children N/A
Completed NCT01044979 - Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma N/A