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临床试验/NCT06354452
NCT06354452已完成不适用

Preadmission Use of Statin Therapy and Sepsis-related Mortality in ICU Patients: a Population-based Cohort Study.

Hospital de Granollers1 个研究点 分布在 1 个国家目标入组 59,578 人开始时间: 2018年1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
59,578
试验地点
1
主要终点
Death due to sepsis

研究概览

简要总结

The average age of patients with sepsis has increased in recent years in parallel with the incidence of sepsis. Many of these patients are frail and require various medications for the treatment of their chronic diseases. Common treatments, including e.g. sarcopenic drugs (statins, sulphonylureas, methyglinides), antioxidants that prevent sarcopenia (allopurinol) or immunoregulators (corticosteroids) may influence the survival and functional prognosis of these patients. Knowing which drugs influence sepsis survival and to what degree patients who survive sepsis have functional deterioration and increased comorbidity and which modifiable factors limit this may be essential.

详细描述

The hypothesis of the study is that poor baseline health status, defined by frailty, comorbidities and chronic drug use, determines sepsis survival and long-term functional status of surviving patients. In addition, the study aims to analize the relationship between different groups of drugs, especially sarcopenal drugs, and sepsis survival in patients admitted to hospitals and Intensive Care Units in a region of 8 million inhabitants. Preliminary data suggest that patients with prior corticosteroid use have poorer survival to sepsis, while chronic statin use may be a protective factor.

This will be a retrospective population-based observational analysis of a large cohort of patients with sepsis using a population-based database over a 2-year period.

The data will be obtained from the Catalan Health System (CatSalut) Minimum Basic Data Set (CMBD) registers (compulsory admissions register for all public and private acute care hospitals in Catalonia, Spain. The registry is intended for the evaluation and optimisation of the use of resources, provides support and improves healthcare planning and facilitates the management of purchases and payments. A cohort of approximately 25,000 patients per year is available from the aforementioned databases (2). Data from 2018 and 2019 (pre-pandemic) will be initially included.

Sepsis will be defined using the methodology described by Angus et al, which is currently referenced for population-based studies, consisting of coding a diagnosis of infection with acute organ failure, or sepsis or septic shock.Patients requiring Intensive Care Unit (ICU) admission were identified from the coded procedures of mechanical ventilation, continuous renal replacement techniques (CRRT), tracheostomy, or extracorporeal membrane oxygenation (ECMO).

To analyse outpatient prescriptions, a patient will be considered to have prior treatment with a given medication if, during the 8 months prior to admission for sepsis, a minimum of 6 containers of that drug had been dispensed. The Anatomical, Therapeutic, Chemical (ATC) drug classification of the World Health Organization (WHO) will be used.

研究设计

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

入排标准

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

入选标准

  • Patients with a diagnosis of sepsis admitted to the hospitals of the public hospital network of Catalonia, Spain. Sepsis will be defined using the methodology described by Angus et al., which is currently referenced for population-based studies, consisting of coding a diagnosis of infection with acute organ failure, or sepsis or septic shock.

排除标准

  • 未提供

结局指标

主要结局

Death due to sepsis

时间窗: From date of hospital admission until the date of hospital discharge, assessed up to 12 months

Inhospital death after an episode of sepsis requiring hospital or ICU admission

次要结局

未报告次要终点

研究者

发起方
Hospital de Granollers
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josep Maria Badia

Prof

Hospital de Granollers

研究点 (1)

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