Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedStudy Start
First participant enrolled
February 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2023
CompletedJuly 28, 2023
July 1, 2023
2.1 years
December 2, 2014
July 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion
24 hours
Study Arms (1)
trauma patients
EXPERIMENTALBlood samples will be collected every 4 hours during 24 h, between day 2 and day 4 after inclusion
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnant and lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hôpitaux de Marseille
Marseille, 13005, France
Related Publications (1)
Coiffard B, Diallo AB, Culver A, Antonini F, Hammad E, Leone M, Mege JL. Exacerbation of circadian rhythms of core body temperature and sepsis in trauma patients. J Crit Care. 2020 Dec;60:23-26. doi: 10.1016/j.jcrc.2020.07.010. Epub 2020 Jul 16.
PMID: 32731102DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Urielle Desalbres
Assistance Publique Hôpitaux de Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2014
First Posted
December 4, 2014
Study Start
February 17, 2015
Primary Completion
March 28, 2017
Study Completion
July 27, 2023
Last Updated
July 28, 2023
Record last verified: 2023-07