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临床试验/NCT07174765
NCT07174765进行中(未招募)不适用

Population-Based Analysis of Incidence and Mortality of Septic Shock: The Registry of Administrative Data Automatically Recorded-Septic Shock Project

Hospital de Granollers1 个研究点 分布在 1 个国家目标入组 31,480 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
进行中(未招募)
发起方
入组人数
31,480
试验地点
1
主要终点
Death due to septic shock

研究概览

简要总结

RADAR-Septic Shock is a population-based observational study in Catalonia (Spain) that will identify all hospital discharges with septic shock between 2018 and 2023 using an audited population-based registry. The project will quantify incidence, describe patient characteristics and resource use, and compare risk-adjusted in-hospital mortality across hospitals to support quality improvement. Cases are defined by ICD-10 codes for septic shock (R65.21) and post-procedural septic shock (T81.12XA). In preliminary cohort counts, >31,000 episodes were identified across 2018-2023; in 2023 the incidence was ~78 per 100,000 inhabitants with an overall in-hospital mortality of ~33%, higher in hospital-acquired than community-acquired episodes

详细描述

Septic shock is the most severe manifestation of sepsis and remains a leading cause of death and healthcare utilisation. Outcomes vary by patient mix (age, comorbidities), acquisition setting, infection source, and hospital performance, underscoring the need for robust, population-level surveillance to guide policy and care pathways. RADAR-Septic Shock leverages routinely collected administrative data to provide standardised measures of incidence, resource use, and outcomes across an entire regional health system.

The study aims to quantify the population incidence of septic shock and describe patient demographics, comorbidity burden, infection sources, organ failures, and use of life-support therapies; 2) estimate in-hospital and short-term mortality and length of stay; and 3) benchmark hospitals using risk-adjusted observed-to-expected (O/E) mortality to identify variation and inform improvement strategies.

It is a population-based cohort using the Catalan Minimum Basic Data Set for Acute Care Hospitals (CMBD-HA), an audited, mandatory discharge registry covering all acute-care hospitals in the public system. The analytic period spans January 2018-December 2023.

It will include all hospital discharges containing a primary or secondary diagnosis code for septic shock (ICD-10-CM R65.21) or post-procedural septic shock (T81.12XA). This definition prioritises specificity and uniformity across centres. Episodes will be stratified by acquisition setting (community- vs hospital-acquired).

Extracted variables include: demographics (age, sex); comorbidities and morbidity burden (Adjusted Morbidity Groups [GMA] index); infection source; organ failures; advanced life-support interventions (mechanical ventilation, renal replacement therapy, ECMO); ICU admission; length of stay; and mortality.

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
否

入选标准

  • •Patients with a diagnosis of septic shock admitted to the hospitals of the public hospital network of Catalonia, Spain. Septic shock 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 septic shock

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 septic shock 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 M Badia

Prof

Hospital de Granollers

研究点 (1)

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