- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02307747
Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma
Circadian rhythms, which play crucial roles in physiology, are emerging as important regulators of specific immune functions. Hospitalization in intensive care unit leads to a deep impairment of circadian rhythm. Infection is a frequent event during ICU hospitalization.
The investigators hypothesis is that in trauma patients the lack of circadian rhythm variations is associated with the occurrence of infection. The primary aim of the study is to assess the circadian variations of plasma Bmal1 in the occurrence of healthcare related infection during the 30 days after inclusion. The secondary aims are to assess the plasma expression of circadian genes (Clock, Cry1, Per3, and Rev-erba), the production of cytokines in plasma, and the concentration of cortisol, according to the occurrence of an infection.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Marseille, France, 13005
- Assistance Publique Hopitaux de Marseille
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Trauma patients with an injury severity score > 15, requiring mechanical ventilation for at least 24 h during the first 48 h and an arterial catheter.
Exclusion Criteria:
- Pregnant and lactating women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: trauma patients
Blood samples will be collected every 4 hours during 24 h, between day 2 and day 4 after inclusion
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Blood samples will be collected every 4 hours during 24 h
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion
Time Frame: 24 hours
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24 hours
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Collaborators and Investigators
Investigators
- Study Director: Urielle DESALBRES, Assistance Publique Hopitaux de Marseille
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-36
- RCAPHM14_0336 (Registry Identifier: APHM)
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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