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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02881268

Acronym

IMPRIM

Enrollment

Registered

2016-08-26

Start date

2016-01-19

Completion date

2021-01-14

Last updated

2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Hospitalized in Intensive Care Unit

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

Interventions

OTHERblood sample

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Association of immunosuppression biomarkers with occurrence of events reflecting a clinical immunosuppression	Day 14	Study of CMV reactivation and nosocomial infections
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026