Point Of Care Testing For Sepsis: A Diagnostic Accuracy Study
Research type
Research Study
Full title
Point Of Care Testing For Sepsis: A Diagnostic Accuracy Study.
IRAS ID
206236
Contact name
Alison Murphy
Contact email
Sponsor organisation
Belfast Health and Social Care Trust
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Sepsis is the term used to describe serious infections. It is caused by microbes, such as bacteria, and one of the most important things in treating patients with sepsis is to give them effective antibiotics as soon as possible to treat the underlying infection.
Many different microbes can cause sepsis. Currently, the usual way to find out for sure which one to target in any particular patient is to wait for it to grow in a laboratory from a sample of their blood, or other samples. As it takes at least 24-48 hours to grow in the laboratory, doctors choose 'best guess' antibiotics that can treat a lot of different microbes before they know which one would be the most effective. These are not always the best antibiotics for that particular individual, and sometimes patients only get the most effective treatment after a result from the laboratory becomes available.
Randox Ltd has recently developed a new bedside device based on technology that is able to identify bacteria in patients' blood within just one hour. Looking only for characteristic fragments of over 40 different microbes means that doctors’ decisions about which treatment to give patients will not need to wait for over a day for the microbe to grow in a laboratory. This will allow treatments to be better targeted from a much earlier stage.
We will evaluate the new test in at least 15 intensive care units (ICUs) across the UK and on 4501 blood samples from patients. Whenever a blood sample is taken for culture as part of routine care, a sample will also be taken for analysis with the new test. Results will be compared to the laboratory culture each time to permit an assessment of how accurate the new test is.
REC name
Scotland A: Adults with Incapacity only
REC reference
16/SS/0108
Date of REC Opinion
7 Jul 2016
REC opinion
Further Information Favourable Opinion