OsteoArticular Sepsis in Intensive Care UnitS

Not yet recruiting

• Conditions: Osteoarticular Infection; Intensive Care Patients

• Registration Number: NCT06627842
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

This is an ambispective observational study of patients admitted to critical care with a diagnosis of osteoarticular infection on material device (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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-04
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Study Start: 2024-12
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patient at least 18 years old.
• No opposition from the patient (or surrogate in case of death)
• Stay in critical care (intensive care or continuing care) between 2018 and 2021 of at least 48 hours, with the principal or associated diagnosis of an osteoarticular

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Exclusion Criteria

• Patient under legal protection.
• Pregnant or breast-feeding patient.
• Patient deprived of liberty.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The profile, trajectories of care during the stay (before or after surgery) and prognosis of patients admitted to critical care with an osteoarticular infection on material device over a period of 2 years following admission to critical care.	2 years

Secondary Outcome Measures

Name	Time	Method
Composite endpoint reflecting poor clinical outcome	2 years	* Mortality, measured in critical care, at 30 days, 1 year and 2 years; * Therapeutic failure at 2 years, defined as mechanical or septic failure.; * Functional failure at 2 years, defined as failure to resume walking and usual activities, to return home, or to regain autonomy.
Mortality at 2 years	2 years
Description of pathogens found in intraoperative samples, and their resistance spectrum	2 years