Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit (IMPRIM)

January 17, 2022 updated by: Rennes University Hospital
Open-label, non-randomized, prospective, single center, observational, translational study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • CHU de Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient hospitalized in intensive care unit with or without sepsis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with sepsis
Patient hospitalized in intensive care unit
Other: blood sample
Patient without sepsis
Patient hospitalized in intensive care unit
Other: blood sample

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2016

Primary Completion (Actual)

January 14, 2021

Study Completion (Actual)

January 14, 2021

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 17, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 35RC15_9903_IMPRIM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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