Comparing creatinine levels in blood and interstitial fluid
Research type
Research Study
Full title
An exploratory study involving healthy volunteers and chronic kidney disease patients to estimate and compare creatinine levels in blood and interstitial fluid
IRAS ID
225598
Contact name
Sandip Mitra
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
1 years, 1 months, 1 days
Research summary
The screening, diagnosis and monitoring of kidney disease is dependent on measurements of creatinine levels from blood sample.This requires a hospital or GP practice attendance and a skilled person to obtain the blood sample which is then transported to a hospital laboratory for analysis. Analysis of creatinine can take several hours to few days depending on the status of urgency and often access to the result is limited by its availability through hospital database or by communication with laboratory staff. This can lead to delay in response to the management of these patients particularly if the kidney function has changed significantly.A minimal invasive and painless method of extraction of interstitial fluid which bathes the tissue cells underneath the skin to estimate toxins e.g creatinine could be an alternative to the conventional blood sample.A tiny drop of tissue fluid could be sufficient to provide an instant measurement of creatinine at bedside or in clinics and could even be used by patients themselves at home to monitor kidney function. Physiologically both the body fluids (blood and skin) should have the same level of creatinine,however the degree of concordance of the levels of creatinine in blood with interstitial fluid has not been examined.
This clinical study aims to analyse a tiny drop (5-10 microlitre) of tissue fluid and a blood sample taken concomitantly for creatinine and other routine analytes measured in blood. The results of this analysis will be compared between blood and tissue fluid. 30 healthy volunteers and 150 patients with chronic kidney disease attending hospital clinics will be invited to undergo the testing which will be carried over 30 mins period during a single visit. The exclusion criteria for the study are inability to consent, age younger than 18 years and any active local skin condition.
REC name
West of Scotland REC 5
REC reference
18/WS/0046
Date of REC Opinion
14 Mar 2018
REC opinion
Favourable Opinion