Functionality of Endogenous Biological Clock in Sepsis (NCT04063332) | Clinical Trial Compass
UnknownNot Applicable
Functionality of Endogenous Biological Clock in Sepsis
Greece60 participantsStarted 2019-06-03
Plain-language 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 with patients without sepsis , the presence of which burdens independently the final outcome and , hence, need to be addressed.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The substantial discrepancy in the values of melatonin, cortisol and core body temperature (central CLOCK circadian markers) between septic and non-septic patients.
Timeframe: 7 days
2
The substantial discrepancy in the circadian rhythms' genes expression levels (peripheral clock markers) between septic and non-septic patients ,within their peripheral blood leucocytes .
Timeframe: 7 days
3
The difference in the extent of deviation from normal, with regard to the values of melatonin-cortisol-core body temperature (circadian triad) between septic and non-septic patients.
Timeframe: 7 days
4
The difference in the extent of deviation from normal, with regard to the levels of circadian rhythms' genes expression (immune system's clock) between septic and non-septic patients ,within their peripheral blood leucocytes .