Status:
UNKNOWN
Functionality of Endogenous Biological Clock in Sepsis
Lead Sponsor:
University of Athens
Collaborating Sponsors:
Hellenic Sepsis Study Group
Conditions:
Circadian Rhythm Disorders
Sepsis
Eligibility:
All Genders
18+ years
Brief Summary
The aim of the current study is to demonstrate dysregulation of immune system΄s circadian rhythms as a consequence of sepsis, as well as marked malfunction of the central circadian clock in comparison...
Detailed Description
Sepsis is number one cause of death within the critically ill patients ,with mortality that reaches a rate of 70%,while in case of the establishment of septic shock and multi organ failure it can rise...
Eligibility Criteria
Inclusion
- Adults (age ≥18 years)
- Written informed consent
- Male or female gender
- Οne of the following cases:
- Healthy controls without comorbidities OR
- Patients without sepsis or infection , with identical Charlson Comorbidity Index and same mental status with the septic patients OR
- Patients with sepsis
Exclusion
- Failure to obtain written informed consent
- Age \<18 years
- Pregnancy or breastfeeding
- Solid tumor or hematologic malignancy
- Asthma
- Neurodegenerative disease
- Traumatic brain injury
- Confirmed depression
- Autoimmune disorders
- Special categories following unfixed or varying routine schedules (e.g. travels overseas or even short distances, if frequent/jet lag/on-call duties/nightshifts with regard to doctors,security guards,singers)
- Per os or iv corticosteroids daily intake of dose at least
- Corticosteroid oral or intravenous intake of at least 0.4 mg/kg of equivalent prednisone daily over the last 15 days
Key Trial Info
Start Date :
June 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04063332
Start Date
June 3 2019
End Date
June 1 2024
Last Update
December 12 2023
Active Locations (2)
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1
2nd Department of Intensive Care Medicine, Attikon University Hospital
Athens, Attica, Greece, 12462
2
4th Department of Internal Medicine, Attikon University Hospital
Athens, Attica, Greece, 12462