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

NCT02881268 | Completed

• 1 other identifier: 35RC15_9903_IMPRIM
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Patient Hospitalized in Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

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

  Day 14

Secondary Outcomes (3)

• Association of immunosuppression biomarkers with occurrence of events reflecting a clinical immunosuppression

  Day 14

• Association of immunosuppression biomarkers with patients demographic data

  Day 14

• Association of immunosuppression biomarkers with patients clinical data

  Day 14

Study Arms (2)

Patient with sepsis

Patient hospitalized in intensive care unit

Other: blood sample

Patient without sepsis

Patient hospitalized in intensive care unit

Other: blood sample

Interventions

blood sample OTHER

Patient with sepsis; Patient without sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient hospitalized in intensive care unit with or without sepsis

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 26, 2016
• Study Start: January 19, 2016
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2021
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)