Back to resultsDisruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma
Primary Purpose
Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood samples
Sponsored by
About this trial
This is an interventional prevention trial for Infection focused on measuring infection in ICU
Eligibility Criteria
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
Sites / Locations
- Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
trauma patients
Arm Description
Blood samples will be collected every 4 hours during 24 h, between day 2 and day 4 after inclusion
Outcomes
Primary Outcome Measures
area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion
Secondary Outcome Measures
Full Information
NCT ID
NCT02307747
First Posted
December 2, 2014
Last Updated
July 27, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02307747
Brief Title
Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma
Official Title
Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 17, 2015 (Actual)
Primary Completion Date
March 28, 2017 (Actual)
Study Completion Date
July 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
infection in ICU
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trauma patients
Arm Type
Experimental
Arm Description
Blood samples will be collected every 4 hours during 24 h, between day 2 and day 4 after inclusion
Intervention Type
Other
Intervention Name(s)
blood samples
Intervention Description
Blood samples will be collected every 4 hours during 24 h
Primary Outcome Measure Information:
Title
area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle Desalbres
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
32731102
Citation
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.
Results Reference
derived
Learn more about this trial
Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma
We'll reach out to this number within 24 hrs