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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01044979
Other study ID # 071223
Secondary ID
Status Completed
Phase N/A
First received December 17, 2009
Last updated July 3, 2014
Start date December 2009
Est. completion date September 2010

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 evaluate a method of sampling interstitial fluid from subcutaneous sewn wicks.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Adults over 18 years

Exclusion Criteria:

- Ongoing illness

- Medication

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 and 90 minuttes after implanting wicks 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 NCT01044641 - Measurement of Colloid Osmotic Pressure in Plasma and Interstitial Fluid in Children N/A