Early PREdiction of Severe Sepsis (ExPRES-Sepsis) study: Protocol for an observational derivation study to discover potential leucocyte cell surface biomarkers

BMJ Open

Volumn 6, Issue 8, 2016, Pages

  Datta, Deepankar ^a   Conway Morris, Andrew ^b   Antonelli, Jean ^c   Warner, Noel ^d   Brown, Kenneth Alun ^e   Wright, John ^f   Simpson, A John ^g   Rennie, Jillian ^h   Hulme, Gillian ⁱ   Lewis, Sion Marc ^a,e   Mare, Tracey Anne ^e   Cookson, Sharon ⁱ   Weir, Christopher John ^a   Dimmick, Ian ^j   Keenan, Jim ^k   Rossi, Adriano Giorgio ^h   Shankar Hari, Manu ^e   Walsh, Timothy S ^a  

^a UNIVERSITY OF EDINBURGH   (United Kingdom)

^b UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^c UNIVERSITY OF EDINBURGH   (United Kingdom)

^d BD BIOSCIENCES   (United States)

^e ST THOMAS HOSPITAL   (United Kingdom)

^f ROYAL VICTORIA INFIRMARY   (United Kingdom)

^g NEWCASTLE UNIVERSITY   (United Kingdom)

^h UNIVERSITY OF EDINBURGH   (United Kingdom)

ⁱ NEWCASTLE UNIVERSITY   (United Kingdom)

^j Instrumentation and Management Consultant   (United Kingdom)

^k BD Biosciences   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; CELL SURFACE MARKER;

ADOLESCENT; ADULT; AGED; ARTICLE; CELL SURFACE; CLINICAL PROTOCOL; COHORT ANALYSIS; CONFIDENTIALITY; CONTROLLED STUDY; CRITICALLY ILL PATIENT; DISEASE COURSE; EMERGENCY WARD; EXPLORATORY RESEARCH; FLOW CYTOMETRY; HOSPITAL ADMISSION; HUMAN; LEUKOCYTE; MIDDLE AGED; MULTICENTER STUDY; OBSERVATIONAL STUDY; OUTCOME ASSESSMENT; PREDICTIVE VALUE; PROSPECTIVE STUDY; PROTOCOL COMPLIANCE; SEPSIS; VERY ELDERLY; BLOOD; CLINICAL TRIAL; CRITICAL ILLNESS; EMERGENCY HEALTH SERVICE; FEMALE; HOSPITAL EMERGENCY SERVICE; HOSPITALIZATION; IMMUNOLOGICAL PROCEDURES; IMMUNOLOGY; MALE; METABOLISM; METHODOLOGY; SCOTLAND; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BIOMARKERS; CRITICAL ILLNESS; EMERGENCY SERVICE, HOSPITAL; FEMALE; HOSPITALIZATION; HUMANS; IMMUNOLOGIC TESTS; LEUKOCYTES; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; RESEARCH DESIGN; SCOTLAND; SEPSIS; TRIAGE; YOUNG ADULT;

EID: 84982811805     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2016-011335     Document Type: Article

References (34)

1. Cronshaw HL, Daniels R, Bleetman A, et al. Impact of the Surviving Sepsis Campaign on the recognition and management of severe sepsis in the emergency department: Are we failing? Emerg Med J 2011;28:670-5.
2. Shapiro N, Howell MD, Bates DW, et al. The association of sepsis syndrome and organ dysfunction with mortality in emergency department patients with suspected infection. Ann Emerg Med 2006;48:583-90.e1.
3. Wang HE, Shapiro NI, Angus DC, et al. National estimates of severe sepsis in United States emergency departments. Crit Care Med 2007;35:1928-36.
4. Bone RC, Balk RA, Cerra FB, et al. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest 1992;101:1644-55.
5. Levy MM, Fink MP, Marshall JC, et al. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Intensive Care Med 2003;29:530-8.
6. Gray AJ, Ward K, Lees F, et al. The epidemiology of adults with severe sepsis and septic shock in Scottish emergency departments. Emerg Med J 2013;30:397-401.
7. Brun-Buisson C. The epidemiology of the systemic inflammatory response. Intensive Care Med 2000;26(Suppl 1):S64-74.
8. Hotchkiss RS, Monneret G, Payen D. Immunosuppression in sepsis: A novel understanding of the disorder and a new therapeutic approach. Lancet Infect Dis 2013;13:260-8.
9. Biron B, Ayala A, Lomas-Neira J. Biomarkers for sepsis: what is and what might be? Biomark Insights 2015;10(Suppl 4):7-17.
10. Davis BH. Improved diagnostic approaches to infection/sepsis detection. Expert Rev Mol Diagn 2005;5:193-207.
11. Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci 2013;50:23-36.
12. Pierrakos C, Vincent JL. Sepsis biomarkers: A review. Crit Care 2010;14:R15.
13. Samraj RS, Zingarelli B, Wong HR. Role of biomarkers in sepsis care. Shock 2013;40:358-65.
14. Seeley EJ, Matthay MA, Wolters PJ. Inflection points in sepsis biology: from local defense to systemic organ injury. Am J Physiol Lung Cell Mol Physiol 2012;303:L355-63.
15. Sackett DL, Haynes RB. The architecture of diagnostic research. BMJ 2002;324:539-41.
16. Department of Health. Comprehensive Critical Care. 2000. http://webarchive.nationalarchives.gov.uk/20130107105354/http:/www.dh. gov.uk/prod-consum-dh/groups/dh-digitalassets/@dh/@en/documents/digitalasset/dh-4082872.pdf
17. Faculty of Intensive Care Medicine, Intensive Care Society. Guidelines for the Provision of Intensive Care Services. 2015. http://members.ics.ac.uk/AsiCommon/Controls/BSA/Downloader. aspx?iDocumentStorageKey=dcbb4ee2-8ad6-4ff4-9d32-451460f 675a4&iFileTypeCode=PDF&iFileName=Guidelines%20for%20the% 20Provision%20of%20Intensive%20Care%20Services
18. Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-Associated infection and criteria for specific types of infections in the acute care setting. Am J Infect Control 2008;36:309-32.
19. Vincent JL, Moreno R, Takala J, et al. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med 1996;22:707-10.
20. Finfer S, Ranieri VM, Thompson BT, et al. Design, conduct, analysis and reporting of a multi-national placebo-controlled trial of activated protein C for persistent septic shock. Intensive Care Med 2008;34:1935-47.
21. Finfer S, Ranieri VM, Thompson BT, et al. Design, conduct, analysis and reporting of a multi-national placebocontrolled trial of activated protein C for persistent septic shock. [Erratum]. Intensive Care Med 2008;34:2319.
22. Daniels R, Nutbeam T, McNamara G, et al. The sepsis six and the severe sepsis resuscitation bundle: A prospective observational cohort study. Emerg Med J 2011;28:507-12.
23. The Royal College of Emergency Medicine. Sepsis. The U. K. Sepsis Trust: The Royal College of Emergency Medicine, 2014:1-24.
24. Tung JW, Heydari K, Tirouvanziam R, et al. Modern flow cytometry: A practical approach. Clin Lab Med 2007;27: 453-68, v.
25. Groll DL, To T, Bombardier C, et al. The development of a comorbidity index with physical function as the outcome. J Clin Epidemiol 2005;58:595-602.
26. British Medical Association, Resuscitation Council (UK), Royal College of Nursing. Decisions relating to cardiopulmonary resuscitation. 3rd edn. London: Guidelines from the British Medical Association, the Resuscitation Council (UK) and the Royal College of Nursing, 2014.
27. Herzenberg LA, Tung J, Moore WA, et al. Interpreting flow cytometry data: A guide for the perplexed. Nat Immunol 2006;7: 681-5.
28. Altman DG. Practical statistics for medical research. London: Chapman & Hall, 2010.
29. Singer M, Deutschman CS, Seymour CW, et al. The Third International Consensus definitions for sepsis and septic shock (Sepsis-3). JAMA 2016;315:801-10.
30. Vincent J-L, de Mendonca A, Cantraine F. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Crit Care 1998;26:1793-800
31. Bone RC, Fisher CJ, Clemmer TP, et al. Sepsis syndrome: A valid clinical entity. Methylprednisolone Severe Sepsis Study Group. Crit Care Med 1989;17:389-93.
32. Cohen J, Vincent JL, Adhikari NKJ, et al. Sepsis: A roadmap for future research. Lancet Infect Dis 2015;15:581-614.
33. Medical Research Council. MRC Guidelines for Good Clinical Practice in Clinical Trials. 1998. https://www.mrc.ac.uk/documents/pdf/good-clinical-practice-in-clinical-Trials/
34. Bossuyt PM, Reitsma JB, Bruns DE, et al. STARD 2015: An updated list of essential items for reporting diagnostic accuracy studies. BMJ 2015;351:h5527.