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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02307747
Enrollment
40
Registered
2014-12-04
Start date
2015-02-17
Completion date
2023-07-27
Last updated
2023-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

infection in ICU

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.

Interventions

OTHERblood samples

Blood samples will be collected every 4 hours during 24 h

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion24 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026