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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307747
• Other study ID #: 2014-36
• Secondary ID: RCAPHM14_0336
• Status: Completed
• Phase: N/A
• Start date: February 17, 2015
• Est. completion date: July 27, 2023

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 27, 2023
• Est. primary completion date: March 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections

Intervention

Other:
• blood samples
Blood samples will be collected every 4 hours during 24 h

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion		24 hours