跳至主要内容
临床试验/CTRI/2019/05/019125
CTRI/2019/05/019125已完成不适用

Prevalence of sepsis in critically ill patients in India: A single-day, prospective, observational, multicentre, nation-wide point-prevalence study

The George Institute for Global Health11 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,000
试验地点
11
主要终点
The primary objective of this project is to examine sepsis epidemiology and characterize the antibiotic use and antimicrobial resistance in Indian ICUs.

研究概览

简要总结

A single-day, prospective, observational, multicentre, nation-wide point-prevalence study of sepsis in Indian Intensive Care Units. Data will be collected over a designated 24-hour study day, starting 08:00 am on the study day till 08:00 am on the following day.  For ICUs participating in this study, a questionnaire to collect hospital- and ICU-level data will be administered along with individual patient data.Data analysis will be guided by a statistical analysis plan, which will be developed before the database is locked. Data analysis will be undertaken at the George Institute for Global Health by statisticians using a statistical software package. To address the primary objectives descriptive statistics will be used including univariate comparisons.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • •All adult patients (18 years or older) present in the ICU at the start of the study day or admitted during the 24-hour study period will be included in the study sample.

排除标准

  • 未提供

结局指标

主要结局

The primary objective of this project is to examine sepsis epidemiology and characterize the antibiotic use and antimicrobial resistance in Indian ICUs.

时间窗: 24 hours

次要结局

  • To describe ICU level processes of care(NA)
  • To describe sepsis patient clinical characteristics, antimicrobial use, treatments received, and 30 day outcomes
  • To undertake a gender specific analysis to determine if prevalence, characteristics and outcomes of male and female patients with sepsis differ(NA)
  • To describe the antibiotic usage and antimicrobial resistance in Indian ICUs(NA)
  • To describe hospital level antibiotic stewardship practices(NA)

研究者

申办方类型
Research institution

研究点 (11)

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