Clinical trial NCT04945889: Sepsis in Geriatric Patients With Suspected Infection.
Official title: La Sepsi Nel Paziente Anziano: Studio Prospettico Sui Pazienti Ricoverati in Ambiente Internistico.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Sepsis
Diagnostic accuracy
Geriatric patients
Older adults
Early Warning Score
qSOFA
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 580
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older patients admitted for any cause, to an acute geriatric ward of a large university teaching hospital in North-western Italy, with at least one NICE risk factor for sepsis, providing written informed consent. Intervention (diagnostic test administration) was performed only in patients with a suspected infection, defined as the prescription of an oral and/or parenteral antibiotic therapy within a timeframe spanning from 24 hours before and 72 hours after the collection of a biological sample to perform a culture test.

Brief summary: Sepsis is a complex clinical syndrome that has been defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection. It is more frequent and severe in older subjects, at least in part because of delayed diagnosis and treatment due to low clinical suspicion and atypical manifestation.

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.


Eligibility criteria: Inclusion Criteria:

* Hospitalization in the Acute Geriatric Unit
* 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:

* Refusal to give written informed consent

Primary outcomes:
measure: Sepsis diagnosis at discharge
timeFrame: 10 days from enrollment in mean (discharge from hospital)
Secondary outcomes:
Other outcomes:
measure: In hospital mortality
timeFrame: 10 days from enrollment in mean (discharge from hospital)
Locations:
city: Turin
country: Italy
facility: S.C. Geriatria U, A.O.U. Città della Salute e della Scienza di Torino
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza
name: Mario Bo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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