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OpenTrials
Completed

NCT Number: NCT02881268

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Rennes

Rennes, 35033, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

blood sample

Other

Primary outcomes

  1. Detection of immunosuppression biomarkers in septic and non-septic patients hospitalized in intensive care unit

    Time frame: Day 14

Secondary outcomes

  1. Association of immunosuppression biomarkers with occurrence of events reflecting a clinical immunosuppression

    Time frame: Day 14

    Study of CMV reactivation and nosocomial infections

  2. Association of immunosuppression biomarkers with patients demographic data

    Time frame: Day 14

    Record of patient age and gender

  3. Association of immunosuppression biomarkers with patients clinical data

    Time frame: Day 14

    Record of severity score, duration of hospitalization, duration of mechanical ventilation, morbidity

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: IMPRIM

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 26, 2016
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.