Study Results
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Basic Information
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COMPLETED
580 participants
OBSERVATIONAL
2019-04-01
2019-10-31
Brief Summary
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The Sepsis-III consensus proposed the easy to use bedside clinical score quick Sequential Organ Failure Assessment (qSOFA) to identify patients at risk for sepsis and death outside intensive care units. However, some Authors have disputed this recommendation, proposting the use of other more complex bedside tools such as the National and Modified Early Warning Scores (NEWS and MEWS, respectively) for the same purpose.
Published studies on these scores included generally younger, selected subjects, not fully representative of the population at risk for sepsis.
In the present study we aimed to evaluate the incidence of sepsis in older subjects with suspected infection in a geriatric acute ward setting, to determine and compare the accuracies of qSOFA, NEWS and MEWS to identify sepsis and to investigate factors associated with in-hospital mortality.
Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Geriatric inpatients at risk for sepsis
Consecutive patients admitted to an Acute Geriatric Unit for any reason presenting at least one National Institute for Health and Care Excellence (NICE) risk factor for sepsis (age ≥75 years, impaired immune function, long-term corticosteroid therapy, immunosuppressive or antineoplastic drug treatment, surgery or other invasive procedures within 6 weeks, any breach of skin integrity, intravenous drug misuse, indwelling lines or catheters).
In those with suspected infection (i.e. antibiotic prescription and a culture test within 24 hours before-72 hours after), clinical parameters (respiratory rate, blood pressure, heart rate, body temperature, peripheral oxygen saturation, mental status) were assessed at least twice daily throughout hospital stay and used by study investigators to determine the qSOFA, NEWS and MEWS.
Quick Sequential Organ Failure Assessment (qSOFA)
Clinical bedside tool that evaluates three vital parameters, scoring one point each if altered: respiratory rate (RR) ≥22 breaths/minute, systolic blood pressure (SBP) ≤100 mmHg and altered mental status (defined in our study as either Glasgow Coma Scale (GCS) score \<15 or any worsening in the Italian Oriented, Disoriented, Agitated, Sleepy scale). A qSOFA score ≥2 points is considered indicative of sepsis.
Modified Early Warning Score (MEWS)
Clinical bedside tool that evaluates five vital parameters, with multiple scoring according to alteration: respiratory rate (0-3 points), heart rate (0-3 points), systolic blood pressure (0-3 points), body temperature (0-2 points), mental status (0-3 points, evaluated using the Alert, Verbal, Pain, Unresponsive - AVPU scale). A MEWS score ≥5 points is considered indicative of an acute condition at risk of sudden clinical deterioration.
National Early Warning Score (NEWS)
Clinical bedside tool that evaluates seven parameters, with multiple scoring according to alteration: respiratory rate (0-3 points), oxygen saturation (0-3 points), need for any supplemental oxygen (0-2 points), body temperature (0-3 points), heart rate (0-3 points), systolic blood pressure (0-3 points), mental status (0-3 points, evaluated using the Alert, Verbal, Pain, Unresponsive - AVPU scale). A NEWS score ≥7 points is considered indicative of an acute condition at risk of sudden clinical deterioration.
Interventions
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Quick Sequential Organ Failure Assessment (qSOFA)
Clinical bedside tool that evaluates three vital parameters, scoring one point each if altered: respiratory rate (RR) ≥22 breaths/minute, systolic blood pressure (SBP) ≤100 mmHg and altered mental status (defined in our study as either Glasgow Coma Scale (GCS) score \<15 or any worsening in the Italian Oriented, Disoriented, Agitated, Sleepy scale). A qSOFA score ≥2 points is considered indicative of sepsis.
Modified Early Warning Score (MEWS)
Clinical bedside tool that evaluates five vital parameters, with multiple scoring according to alteration: respiratory rate (0-3 points), heart rate (0-3 points), systolic blood pressure (0-3 points), body temperature (0-2 points), mental status (0-3 points, evaluated using the Alert, Verbal, Pain, Unresponsive - AVPU scale). A MEWS score ≥5 points is considered indicative of an acute condition at risk of sudden clinical deterioration.
National Early Warning Score (NEWS)
Clinical bedside tool that evaluates seven parameters, with multiple scoring according to alteration: respiratory rate (0-3 points), oxygen saturation (0-3 points), need for any supplemental oxygen (0-2 points), body temperature (0-3 points), heart rate (0-3 points), systolic blood pressure (0-3 points), mental status (0-3 points, evaluated using the Alert, Verbal, Pain, Unresponsive - AVPU scale). A NEWS score ≥7 points is considered indicative of an acute condition at risk of sudden clinical deterioration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presence of at least one National Institute for Health and Care Excellence (NICE) guidance risk factor for sepsis (i.e. age ≥75 years, impaired immune function - diabetes mellitus, previous splenectomy, hematologic diseases - long-term corticosteroid therapy, immunosuppressive or antineoplastic drug treatment, surgery or other invasive procedures in the previous 6 weeks, any breach of skin integrity - e.g. pressure ulcers - intravenous drug misuse, indwelling lines or catheters)
Exclusion Criteria
65 Years
ALL
No
Sponsors
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A.O.U. Città della Salute e della Scienza
OTHER
Responsible Party
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Mario Bo
Director, S.C. Geriatria U, Molinette Hospital
Principal Investigators
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Mario Bo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
A.O.U. Città della Salute e della Scienza
Locations
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S.C. Geriatria U, A.O.U. Città della Salute e della Scienza di Torino
Turin, , Italy
Countries
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References
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Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
Rowe TA, McKoy JM. Sepsis in Older Adults. Infect Dis Clin North Am. 2017 Dec;31(4):731-742. doi: 10.1016/j.idc.2017.07.010.
Seymour CW, Liu VX, Iwashyna TJ, Brunkhorst FM, Rea TD, Scherag A, Rubenfeld G, Kahn JM, Shankar-Hari M, Singer M, Deutschman CS, Escobar GJ, Angus DC. Assessment of Clinical Criteria for Sepsis: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):762-74. doi: 10.1001/jama.2016.0288.
Song JU, Sin CK, Park HK, Shim SR, Lee J. Performance of the quick Sequential (sepsis-related) Organ Failure Assessment score as a prognostic tool in infected patients outside the intensive care unit: a systematic review and meta-analysis. Crit Care. 2018 Feb 6;22(1):28. doi: 10.1186/s13054-018-1952-x.
Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. doi: 10.1093/qjmed/94.10.521.
Smith GB, Prytherch DR, Meredith P, Schmidt PE, Featherstone PI. The ability of the National Early Warning Score (NEWS) to discriminate patients at risk of early cardiac arrest, unanticipated intensive care unit admission, and death. Resuscitation. 2013 Apr;84(4):465-70. doi: 10.1016/j.resuscitation.2012.12.016. Epub 2013 Jan 4.
Kramer AA, Sebat F, Lissauer M. A review of early warning systems for prompt detection of patients at risk for clinical decline. J Trauma Acute Care Surg. 2019 Jul;87(1S Suppl 1):S67-S73. doi: 10.1097/TA.0000000000002197.
Related Links
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Other Identifiers
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0069708/2019
Identifier Type: -
Identifier Source: org_study_id