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临床试验/NCT04945889
NCT04945889已完成不适用

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

A.O.U. Città della Salute e della Scienza1 个研究点 分布在 1 个国家目标入组 580 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
580
试验地点
1
主要终点
Sepsis diagnosis at discharge

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Refusal to give written informed consent

结局指标

主要结局

Sepsis diagnosis at discharge

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
A.O.U. Città della Salute e della Scienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Bo

Director, S.C. Geriatria U, Molinette Hospital

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

研究点 (1)

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