跳至主要内容
临床试验/NCT06627842
NCT06627842暂停不适用

OSTEOARTICULAR SEPSIS ON EQUIPMENT in Intensive Care and Continuing Care Units in France

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年3月31日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
150
试验地点
1
主要终点
The profile, trajectories of care during the stay (before or after surgery) and the prognosis of patients admitted to intensive care for joint prosthesis infection over a 2-year period after admission to intensive care.

研究概览

简要总结

This is an ambispective observational study of patients admitted to intensive care with a diagnosis of joint prosthesis infection (mainly knee and hip prostheses). The main objective of the study is to describe the profile, care trajectories during the stay (before or after surgery) and prognosis of patients admitted to critical care with such an infection. We also aim to compare prognosis between different groups of patients sharing the same profile and care trajectory, and to assess independent risk factors associated with 2-year mortality among the study population. Finally, we will describe the microbiological and resistance profile of severe osteoarticular device infections requiring critical care admission in France.

This is a descriptive and analytical observational study open to all French public and private hospitals.

Patient data will be retrieved prospectively from patient source files. Only 2-year data (vital status, functional data) will be collected specifically for the study, by telephone contact with the patient or his or her support person.

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

  • •Patient at least 18 years old.
  • •Hospitalization in critical care (intensive care unit or continuing care unit) between 2018 and 2022 of at least 48 hours, with prosthetic joint infection (hip, knee or shoulder prosthesis infection) as the main or associated diagnosis.

排除标准

  • •Infection on osteosynthesis material
  • •Infection on spinal equipment
  • •Patient with several infected prostheses
  • •Recurrence of infection on prosthesis with the same microorganism
  • •Patient opposing data collection
  • •Patient under legal protection.
  • •Pregnant or breast-feeding patient.
  • •Patient deprived of liberty.

研究组 & 干预措施

Global cohort

All patients admitted to intensive care during the study period

结局指标

主要结局

The profile, trajectories of care during the stay (before or after surgery) and the prognosis of patients admitted to intensive care for joint prosthesis infection over a 2-year period after admission to intensive care.

时间窗: 2 years

次要结局

  • Composite endpoint reflecting poor clinical outcome(2 years)
  • Mortality at 2 years(2 years)
  • Description of pathogens found in intraoperative samples, and their resistance spectrum(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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