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Sepsis in Geriatric Patients With Suspected Infection.

La Sepsi Nel Paziente Anziano: Studio Prospettico Sui Pazienti Ricoverati in Ambiente Internistico.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04945889
Enrollment
580
Registered
2021-06-30
Start date
2019-04-01
Completion date
2019-10-31
Last updated
2021-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

Sepsis, Diagnostic accuracy, Geriatric patients, Older adults, Early Warning Score, qSOFA

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.

Interventions

DIAGNOSTIC_TESTQuick 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.

DIAGNOSTIC_TESTModified 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.

DIAGNOSTIC_TESTNational 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.

Sponsors

A.O.U. Città della Salute e della Scienza
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sepsis diagnosis at discharge10 days from enrollment in mean (discharge from hospital)Presence in discharge documents of International Classification of Diseases 9th revision, Clinical Modification (ICD-9-CM) codes at discharge of either severe sepsis (995.92) or septic shock (785.52) or as the simultaneous presence in discharge documents of ICD-9-CM codes of infection and at least one acute organ dysfunction (Angus method).

Other

MeasureTime frameDescription
In hospital mortality10 days from enrollment in mean (discharge from hospital)Presence in discharge documents of death during hospital stay for any cause.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026