An observational study in Sepsis, Septic Shock and Inflammation, sponsored by Melahat Yalcin Solak. Not yet recruiting at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by Melahat Yalcin Solak · Observational
This study aims to investigate the blood levels of two recently identified immune-related proteins, Interleukin-40 (IL-40) and Interleukin-41 (IL-41), in patients with sepsis and its more severe form, septic shock. Sepsis is a serious condition caused by an abnormal immune response to infection, which can lead to organ dysfunction. Septic shock represents an advanced stage of sepsis, characterized by significantly higher mortality risk.
IL-40 and IL-41 are newly discovered molecules that are thought to play important roles in the immune system. In this study, the blood concentrations of IL-40 and IL-41 in patients diagnosed with sepsis or septic shock will be measured and compared with those in healthy individuals. The findings may contribute to understanding whether these proteins can be used as biomarkers in the diagnosis or monitoring of treatment in sepsis-related conditions.
Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to infection and is evaluated by an increase of two or more points in the Sequential Organ Failure Assessment (SOFA) score. Septic shock is characterized by hypotension that persists despite adequate fluid resuscitation (mean arterial pressure ≤65 mmHg) and a serum lactate level greater than 2 mmol/L. Septic shock represents a more severe clinical condition, with mortality rates reaching up to 60%.
Interleukin-40 (IL-40) is a recently discovered pro-inflammatory cytokine encoded by the chromosome 17 open reading frame 99 (C17orf99) gene. It is primarily produced by bone marrow, fetal liver, and activated peripheral B cells. IL-40 plays an essential role in immunoglobulin A production, humoral immune regulation, and B cell development. It has also been implicated in the pathogenesis of inflammatory diseases such as rheumatoid arthritis.
Interleukin-41 (IL-41), also known as meteorin-like protein (Metrnl), was identified in 2004 and is encoded by the meteorin-like (METRNL) gene located on chromosome 17q25.3. IL-41 is an anti-inflammatory cytokine expressed in tissues such as the intestines, skin, respiratory tract, and central nervous system. It is secreted primarily by alternatively activated macrophages and M2-like macrophages and has roles in both innate and adaptive immune responses.
The roles of IL-40 and IL-41 in sepsis and septic shock have not yet been fully elucidated. Understanding the involvement of these novel cytokines in inflammatory processes may provide new insights into the diagnosis and treatment of critical conditions such as sepsis and septic shock. The aim of this study is to compare IL-40 and IL-41 levels in patients diagnosed with sepsis or septic shock to those of healthy individuals.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 80 is below the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →This is the only study on the registry with Melahat Yalcin Solak as lead sponsor.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The study population will consist of two cohorts: (1) patients diagnosed with sepsis or septic shock based on Sepsis-3 criteria, and (2) healthy adult volunteers. Patients will be recruited from intensive care units and emergency departments, prior to the initiation of antibiotic therapy. Healthy controls will be selected based on clinical evaluation and medical history, confirming the absence of acute or chronic illness. All participants will be aged 18 years or older.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical diagnosis of sepsis or septic shock, based on validated diagnostic criteria (e.g., Sepsis-3)
Age 18 years or older
Ability and willingness to provide a blood sample prior to initiation of antibiotic treatment
Healthy Control Group:
Determined to be in good general health based on physical examination and medical history
Age 18 years or older
Willingness to provide written
Exclusion Criteria:
History of chronic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
Active cancer or current use of therapy
Pregnant or breastfeeding
Presence of other serious conditions that may interfere with diagnosis or treatment (e.g., liver failure, chronic kidney disease)
Healthy Control Group:
Recent infection within the past month or use of antibiotics in the last 6 weeks
History of chronic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
Underwent surgery within the past 6 months
Conditions that may affect blood parameters, such as recent blood donation or intense physical activity
Pregnant or breastfeeding
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort will include patients diagnosed with sepsis or septic shock based on the Sepsis-3 criteria. A one-time blood sample will be collected from each participant to analyze serum IL-40 and IL-41 levels. No intervention will be administered.
Other: No intervention; Observational study
Healthy volunteers with no history of chronic disease or recent infection. A single blood sample will be collected to measure baseline IL-40 and IL-41 levels.
Other: No intervention; Observational study
No interventions are associated with either group. This is an observational study without experimental procedures.
Comparison of Serum IL-40 Levels Between Patients With Sepsis or Septic Shock and Healthy Controls
IL-40 concentration will be measured in serum samples from both groups using an ELISA-based method. The mean IL-40 levels will be compared between sepsis/septic shock patients and healthy individuals.
Time frame: At time of enrollment (single time point)
Comparison of Serum IL-41 Levels Between Patients With Sepsis or Septic Shock and Healthy Controls
IL-41 concentration will be measured in serum samples from both groups using an ELISA-based method. The mean IL-41 levels will be compared between sepsis/septic shock patients and healthy individuals.
Time frame: At time of enrollment (single time point)
Correlation Between IL-40 and IL-41 Levels in All Participants
The study will assess the correlation between serum IL-40 and IL-41 levels among all participants, including both patient and control groups.
Time frame: At time of enrollment (single time point)
Plan to share: No — Individual participant data will not be shared due to ethical considerations, limited sample size, and absence of a formal data-sharing infrastructure.
Start is estimated for May 2025; primary completion for Nov 2025, 6 months later.
Of 189 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 6 months is below that.
Counting every sponsor, half of 202 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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