Disruption of Circadian Rhythm and Healthcare-related Inf... | NCT02307747

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

NCT02307747

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Jul 28, 2023Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Infection

Interventions

blood samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RCAPHM14_0336	Registry Identifier	APHM

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2015Actual

Primary Completion Date

Mar 28, 2017Actual

Completion Date

Jul 27, 2023Actual

First Submitted Date

Dec 2, 2014

First Submission Date that Met QC Criteria

Dec 3, 2014

First Posted Date

Dec 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2023

Last Update Posted Date

Jul 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
trauma patients	Experimental	Blood samples will be collected every 4 hours during 24 h, between day 2 and day 4 after inclusion	Other: blood samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood samples	Other	Blood samples will be collected every 4 hours during 24 h	trauma patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urielle Desalbres	Assistance Publique Hôpitaux de Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hôpitaux de Marseille		Marseille		13005	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32731102	Derived	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.

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis