Sepsis in Geriatric Patients With Suspected Infection.

Study Overview
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Brief Summary
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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.

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

Conditions
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Sepsis

Intervention / Treatment
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* Diagnostic Test: Quick Sequential Organ Failure Assessment (qSOFA)
* Diagnostic Test: Modified Early Warning Score (MEWS)
* Diagnostic Test: National Early Warning Score (NEWS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Geriatric inpatients at risk for sepsis<br>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. | Diagnostic Test: Quick Sequential Organ Failure Assessment (qSOFA)<br>* 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.<br>* Other names: Quick Sepsis-Related Organ Failure Assessment;Diagnostic Test: Modified Early Warning Score (MEWS)<br>* 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.<br>Diagnostic Test: National Early Warning Score (NEWS)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis diagnosis at discharge | 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). | 10 days from enrollment in mean (discharge from hospital) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Diagnostic accuracy, Geriatric patients, Older adults, Early Warning Score, qSOFA