Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit

Completed

• Conditions: Patient Hospitalized in Intensive Care Unit

• Registration Number: NCT02881268
• Lead Sponsor: Rennes University Hospital

Brief Summary

Open-label, non-randomized, prospective, single center, observational, translational study

Detailed Description

The aim of this trial is to study immunosuppression biomarkers in patients hospitalized in intensive care unit in comparison to non-septic patients.

Prevalence of immunosuppression acquired in intensive care unit will be studied and patients most likely to develop nosocomial infection will be early identified

Study Timeline

• Study Start: 2016-01-19
• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-26
• Primary Completion: 2021-01-14
• Study Completion: 2021-01-14
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Patient older than 18 years old
• Patient hospitalized in intensive care unit for any reason
• Patient with infection started less than 5 days before admission
• Patient with mechanical ventilation or not
• Patient with arterial catheter for an invasive monitoring of blood pressure
• Patient informed about the study protocol and approved to participate.
• Patients hospitalized for a severe bacterial infection (severe sepsis or septic shock)
• Patient hospitalized for a non-infectious disease

Exclusion Criteria

• Pregnancy
• Advanced immunosuppression defined by proved humoral or cellular impairment by continuous administration of steroids at any dose since more than one month before hospitalization, transplantation, radiotherapy or chemotherapy in the preceding year
• Initiation of an immunosuppressive therapy as chemotherapy, cyclophosphamide or high dose corticotherapy (>0.5mg/kg/day)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of immunosuppression biomarkers in septic and non-septic patients hospitalized in intensive care unit	Day 14

Secondary Outcome Measures

Name	Time	Method
Association of immunosuppression biomarkers with patients demographic data	Day 14	Record of patient age and gender
Association of immunosuppression biomarkers with patients clinical data	Day 14	Record of severity score, duration of hospitalization, duration of mechanical ventilation, morbidity
Association of immunosuppression biomarkers with occurrence of events reflecting a clinical immunosuppression	Day 14	Study of CMV reactivation and nosocomial infections

Trial Locations

Locations (1)

CHU de Rennes; 🇫🇷 Rennes, France