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

NCT ID: NCT02881268

Last Updated: 2022-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-19

Study Completion Date

2021-01-14

Brief Summary

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

Detailed Description

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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

Conditions

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Patient Hospitalized in Intensive Care Unit

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with sepsis

Patient hospitalized in intensive care unit

blood sample

Intervention Type OTHER

Patient without sepsis

Patient hospitalized in intensive care unit

blood sample

Intervention Type OTHER

Interventions

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blood sample

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Rennes

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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35RC15_9903_IMPRIM

Identifier Type: -

Identifier Source: org_study_id

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