Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma

July 3, 2014 updated by: Haukeland University Hospital

Measurements of Colloid Osmotic Pressure in Interstitial Fluid and Plasma, a Methodological Study

The purpose of this study is to evaluate a method of sampling interstitial fluid from subcutaneous sewn wicks.

Study Overview

Status

Completed

Conditions

Detailed Description

Fluid loss from circulating plasma volume is one of the contributors of oedema formation. Measurement of colloid osmotic pressure (COP) both in plasma and in interstitial fluid can be utilised in planing of fluid therapy in patients with oedema. Different methods of sampling interstitial fluid are well validated in animal models, but not in human. Sampling of interstitial fluid by subcutaneous sewn wicks is a well-known method and can be painful. Local anaesthetics can reduce pain. By comparing interstitial fluid taken from areas with or without application of local anaesthetics, a possible influence in COP values can be detected.

Study Type

Observational

Enrollment (Actual)

50

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

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers over 18 years.

Description

Inclusion Criteria:

  • Adults over 18 years

Exclusion Criteria:

  • Ongoing illness
  • Medication

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 and 90 minuttes after implanting wicks
60 and 90 minuttes after implanting wicks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Investigators

  • Principal Investigator: Hans Joergen T Guthe, MD, Haukeland 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.

General Publications

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)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

January 7, 2010

First Posted (Estimate)

January 8, 2010

Study Record Updates

Last Update Posted (Estimate)

July 4, 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

  • 071223

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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