Skip to main content
OpenTrials
Completed

NCT Number: NCT04945889

Sepsis in Geriatric Patients With Suspected Infection.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

S.C. Geriatria U, A.O.U. Città della Salute e della Scienza di Torino

Turin, 10128, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quick Sequential Organ Failure Assessment (qSOFA)

Diagnostic Test

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.

Other names: Quick Sepsis-Related Organ Failure Assessment

Modified Early Warning Score (MEWS)

Diagnostic Test

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)

Diagnostic Test

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.

Primary outcomes

  1. Sepsis diagnosis at discharge

    Time frame: 10 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 outcomes

  1. In hospital mortality

    Time frame: 10 days from enrollment in mean (discharge from hospital)

    Presence in discharge documents of death during hospital stay for any cause.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 30, 2021
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.