Measurement of Colloid Osmotic Pressure in Plasma and Interstitial Fluid in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01044641
First received: January 6, 2010
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition
Colloid Osmotic Pressure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Colloid Osmotic Pressure in Plasma and Interstitial Fluid in Children

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Colloid osmotic pressure [ Time Frame: 60 minuttes after wick insertion ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Interstitial fluid and serum


Enrollment: 99
Study Start Date: December 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Secondary care clinic (ENT)

Criteria

Inclusion Criteria:

  • Children from 2 to 10 years

Exclusion Criteria:

  • Medication
  • Ongoing illness
  • Syndromes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044641

Locations
Norway
Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Hans Joergen T Guthe, MD Hanukeland University Hospital
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01044641     History of Changes
Other Study ID Numbers: 065816
Study First Received: January 6, 2010
Last Updated: January 7, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Haukeland University Hospital:
Colloid Osmotic pressure in interstitial fluid
Colloid Osmotic pressure in plasma
Protein fractions in interstitial fluid

ClinicalTrials.gov processed this record on April 17, 2014