Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion
Time Frame: 24 hours
Secondary Outcomes
No secondary outcomes reported