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临床试验/NCT03678298
NCT03678298Unknown不适用

Italian Register for the Study of Complicated Intra-Abdominal Infections (IRCA) Study

World Society of Emergency Surgery1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Mortality rates linked to different sources of infection

研究概览

简要总结

The study will identify the epidemiological and treatment profiles of acute peritonitis in Italy

详细描述

The primary objectives of the study are: (1) the identification of specific risk factors for in-hospital mortality, in order to perfect the clinical management of patients with complicated intra-abdominal infections (cIAIs); (2) the identification of specific risk factors for multi-drug resistant organisms (MDROs) isolation in patients with cIAIs, in order to improve the adequacy of empirical antimicrobial therapy.

The secondary objectives are: (1) the description of the clinical, diagnostic and treatment profiles of patients with cIAIs in Italian surgical departments; (2) the analysis of epidemiology and patterns of antimicrobial susceptibility of the microorganisms isolated in samples in intra-operative samples of peritoneal fluid or purulent exudate/discrete abscesses in patients with cIAIs; (3) the identification of specific risk factors for post-operative complications in patients with cIAIs.

研究设计

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

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All consecutively hospitalized adult patients (older than 18 years of age) undergoing surgery, interventional drainage or conservative treatment, with diagnosis of cIAIs (defined as abdominal infections originating in an organ cavity, extending into the peritoneal space, and forming an abscess or peritonitis)

排除标准

  • Patients younger than 16 years-old, patients with pancreatitis or primary peritonitis

结局指标

主要结局

Mortality rates linked to different sources of infection

时间窗: 12 months

Mortality rates linked to different bacteria causing infection

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
World Society of Emergency Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Massimo Sartelli

Medical Doctor

World Society of Emergency Surgery

研究点 (1)

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