The SepEd Study
Research type
Research Study
Full title
The SepED Study: Developing a Rapid, Point-of-Care Spectroscopic Blood Test for the Early Diagnosis of Sepsis.
IRAS ID
272471
Contact name
Matthew Baker
Contact email
Sponsor organisation
Legal Counsel to the University of Strathclyde
Duration of Study in the UK
1 years, 7 months, 28 days
Research summary
It is estimated that there are approximately 250,000 new cases of sepsis per year in the UK, resulting in 46,000 deaths annually and approximately 120 deaths occurring each day with incidents increasing between 10-13% each year. The diagnosis of sepsis is challenging due to the unspecific symptoms that are similar to that of other causes, including non-infectious causes. Currently scoring systems are used to identify at risk patients however, they are insufficient at identifying patients at the early stages. The definite diagnosis of sepsis can only be achieved by positive blood culture results that can take up to three days to obtain the results.
Participation in this study will involve a single blood sample collection that will be taken alongside the NHS required samples. Participants will be recruited from the emergency department at the Queen Elizabeth University Hospital and will either have a proven or suspected infection or two or more of the SIRS criteria and require antibiotics. All participants will required full informed and written consent for the blood collection and the collection of relevant demographic data (age, sex, blood test results, diagnosis etc). Excluded participants include those under 18 years, prisoners, pregnant and any patient unable to fully consent.
We propose to use spectroscopy techniques to develop a point-of-care blood sampling test for the quantification of neutrophils, allowing for a faster diagnosis of infections and sepsis within the emergency department. The spectroscopic techniques will be compared to the hospital laboratory results generated by the automated haematology systems. It is expected that this will allow for the earlier initiation of treatment, close monitoring of patient status and to overall improve patient outcomes. Subsequently we aim to use this device to aid in the evaluation of the risk of the patient and determination of normal or abnormal neutrophil count.REC name
Wales REC 6
REC reference
20/WA/0060
Date of REC Opinion
18 Feb 2020
REC opinion
Favourable Opinion