Early PREdiction of Severe Sepsis (ExPRES-Sepsis) study: protocol for an observational derivation study to discover potential leucocyte cell surface biomarkers.
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Authors
Antonelli, Jean
Warner, Noel
Brown, Kenneth Alun
Wright, John
Simpson, A John
Rennie, Jillian
Hulme, Gillian
Lewis, Sion Marc
Mare, Tracey Anne
Cookson, Sharon
Weir, Christopher John
Dimmick, Ian
Keenan, Jim
Rossi, Adriano Giorgio
Shankar-Hari, Manu
Walsh, Timothy S
ExPRES Sepsis Investigators
Publication Date
2016-08-01Journal Title
BMJ Open
ISSN
2044-6055
Publisher
BMJ
Volume
6
Issue
8
Pages
e011335
Language
eng
Type
Article
This Version
VoR
Physical Medium
Electronic
Metadata
Show full item recordCitation
Datta, D., Conway Morris, A., Antonelli, J., Warner, N., Brown, K. A., Wright, J., Simpson, A. J., et al. (2016). Early PREdiction of Severe Sepsis (ExPRES-Sepsis) study: protocol for an observational derivation study to discover potential leucocyte cell surface biomarkers.. BMJ Open, 6 (8), e011335. https://doi.org/10.1136/bmjopen-2016-011335
Abstract
INTRODUCTION: Sepsis is an acute illness resulting from infection and the host immune response. Early identification of individuals at risk of developing life-threatening severe sepsis could enable early triage and treatment, and improve outcomes. Currently available biomarkers have poor predictive value for predicting subsequent clinical course in patients with suspected infection. Circulating leucocytes provide readily accessible tissues that reflect many aspects of the complex immune responses described in sepsis. We hypothesise that measuring cellular markers of immune responses by flow cytometry will enable early identification of infected patients at risk of adverse outcomes. We aim to characterise leucocyte surface markers (biomarkers) and their abnormalities in a population of patients presenting to the hospital emergency department with suspected sepsis, and explore their ability to predict subsequent clinical course. METHODS AND ANALYSIS: We will conduct a prospective, multicentre, clinical, exploratory, cohort observational study. To answer our study question, 3 patient populations will be studied. First, patients with suspected sepsis from the emergency department (n=300). To assess performance characteristics of potential tests, critically ill patients with established sepsis, and age and gender matched patients without suspicion of infection requiring hospital admission (both n=100) will be recruited as comparator populations. In all 3 groups, we plan to assess circulating biomarker profiles using flow cytometry. We will select candidate biomarkers by cross-cohort comparison, and then explore their predictive value for clinical outcomes within the cohort with suspected sepsis. ETHICS AND DISSEMINATION: The study will be carried out based on the principles in the Declaration of Helsinki and the International Conference on Harmonisation Good Clinical Practice. Ethics approval has been granted from the Scotland A Research Ethics Committee (REC) and Oxford C REC. On conclusion of this study, the results will be disseminated via peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT02188992; Pre-results.
Keywords
ExPRES Sepsis Investigators, Leukocytes, Humans, Sepsis, Critical Illness, Immunologic Tests, Hospitalization, Prospective Studies, Research Design, Adolescent, Adult, Aged, Aged, 80 and over, Middle Aged, Emergency Service, Hospital, Triage, Scotland, Female, Male, Young Adult, Biomarkers
Identifiers
External DOI: https://doi.org/10.1136/bmjopen-2016-011335
This record's URL: https://www.repository.cam.ac.uk/handle/1810/278213
Rights
Attribution-NonCommercial 4.0 International
Licence URL: http://creativecommons.org/licenses/by-nc/4.0/
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