Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Infection

Treatments: Other: blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02307747

RCAPHM14_0336 (Registry Identifier)

2014-36

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

trauma patients

Experimental group

Description:

Blood samples will be collected every 4 hours during 24 h, between day 2 and day 4 after inclusion

Treatment:

Other: blood samples