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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-17

Study Completion Date

2023-07-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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trauma patients

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

Group Type EXPERIMENTAL

blood samples

Intervention Type OTHER

Blood samples will be collected every 4 hours during 24 h

Interventions

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blood samples

Blood samples will be collected every 4 hours during 24 h

Intervention Type OTHER

Eligibility Criteria

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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.