Understanding the role of the body's biological clock in sepsis
Functionality of Endogenous Biological Clock in Sepsis
This study looks at how sepsis affects the body's natural clock and immune system to see if understanding this can help improve treatment for patients with sepsis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Athens Academic / other |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Athens, Attiki and 1 other locations) |
| Trial ID | NCT04063332 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how sepsis disrupts the immune system's circadian rhythms and the central circadian clock. By comparing septic patients to healthy controls and patients without sepsis, the study seeks to identify the extent of this dysregulation and its impact on patient outcomes. The research will analyze the expression of genes related to circadian rhythms and their influence on immune function during sepsis. The findings could provide insights into potential therapeutic approaches to improve sepsis management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older, either healthy controls, patients without sepsis, or patients diagnosed with sepsis.
Not a fit: Patients with certain conditions such as solid tumors, neurodegenerative diseases, or those on corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for sepsis by addressing circadian rhythm disruptions.
How similar studies have performed: While the specific approach of this study may be novel, previous research has indicated the importance of circadian rhythms in immune function, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Athens, Attiki and 1 other locations
- 2nd Department of Intensive Care Medicine, Attikon University Hospital — Athens, Attiki, Greece (Recruiting)
- 4th Department of Internal Medicine, Attikon University Hospital — Athens, Attiki, Greece (Recruiting)
Study contacts
- Principal investigator: Evangelos J Giamarellos-Bourboulis, MD, PhD — University of Athens
- Study coordinator: Evangelos J Giamarellos-Bourboulis, MD, PhD
- Email: egiamarel@med.uoa.gr
- Phone: +302107480662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.