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

Patient Hospitalized in Intensive Care Unit Clinical Trial

— IMPRIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02881268
• Other study ID #: 35RC15_9903_IMPRIM
• Status: Completed
• Start date: January 19, 2016
• Est. completion date: January 14, 2021

Study information

• Verified date: January 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 14, 2021
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Patient Hospitalized in Intensive Care Unit

Intervention

Other:
• blood sample

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of immunosuppression biomarkers in septic and non-septic patients hospitalized in intensive care unit		Day 14
Secondary	Association of immunosuppression biomarkers with occurrence of events reflecting a clinical immunosuppression	Study of CMV reactivation and nosocomial infections	Day 14
Secondary	Association of immunosuppression biomarkers with patients demographic data	Record of patient age and gender	Day 14
Secondary	Association of immunosuppression biomarkers with patients clinical data	Record of severity score, duration of hospitalization, duration of mechanical ventilation, morbidity	Day 14