SepsisNCT06963541
IL-40 and IL-41 Levels in Sepsis, Septic Shock, and Healthy Individuals
An observational study of Sepsis and Septic Shock, run by Melahat Yalcin Solak at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Septic Shock, Inflammation
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patient Group:
- 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 informed consent
Who cannot join
- Patient Group:
- History of chronic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- Active cancer or current use of immunosuppressive 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:
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Harran University Faculty of Medicine, Department of Anesthesiology and Reanimation
Sanliurfa, 630000
Evren BÜYÜKFIRAT, Medical Doctor, +905065849686, evrenbf@gmail.com
About this study
Official title: Comparison of IL-40 and IL-41 Levels in Patients With Sepsis and Septic Shock to Healthy Individuals
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.
Read the detailed description
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.
- Conditions
- Sepsis, Septic Shock, Inflammation, Biomarkers
- Being tested
- No intervention; Observational study
- Keywords
- IL-40, IL-41, Cytokines, Critical Illness, Septic Shock, Sepsis
- Medical subject headings
- Sepsis, Shock, Septic, Inflammation, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention; Observational studyOther
No interventions are associated with either group. This is an observational study without experimental procedures.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis or Septic Shock Group | 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. Receives: Other: No intervention; Observational study | |
| Healthy Control Group | 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. Receives: Other: No intervention; Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At time of enrollment (single time point)
Secondary outcomes (1)
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.
Measured: At time of enrollment (single time point)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start15 May 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Melahat Yalcin Solak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melahat Yalcin Solak, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963541
- Sponsor's protocol ID
- HRÜ.27.01.25
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical considerations, limited sample size, and absence of a formal data-sharing infrastructure.
Publications
Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
PubMed 34599691Cai S, Li X, Zhang C, Jiang Y, Liu Y, He Z, Ma S, Yao Y, Wong CK, Wu G, Gao X. Inhibition of Interleukin-40 prevents multi-organ damage during sepsis by blocking NETosis. Crit Care. 2025 Jan 16;29(1):29. doi: 10.1186/s13054-025-05257-2.
PubMed 39819454
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of IL-40 and IL-41 Levels in Patients With Sepsis and Septic Shock to Healthy Individuals
- ClinicalTrials.gov ID
- NCT06963541
- Acronym / sponsor ID
- HRÜ.27.01.25
- Conditions
- Sepsis, Septic Shock, Inflammation, Biomarkers
- Keywords
- IL-40, IL-41, Cytokines, Critical Illness, Septic Shock, Sepsis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Melahat Yalcin SolakUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis or Septic Shock Group | – | Other: No intervention; Observational studyThis 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. |
| Healthy Control Group | – | Other: No intervention; Observational studyHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Patient Group:
- 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
- Determined to be in good general health based on physical examination and medical history
Key exclusion criteria (11 listed)
- Patient Group:
- History of chronic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus)
- Active cancer or current use of immunosuppressive therapy
- Pregnant or breastfeeding
- Presence of other serious conditions that may interfere with diagnosis or treatment (e.g., liver failure, chronic kidney disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention; Observational studyNo interventions are associated with either group. This is an observational study without experimental procedures. | Other | Healthy Control Group, Sepsis or Septic Shock Group |
Primary outcome
Comparison of Serum IL-40 Levels Between Patients With Sepsis or Septic Shock and Healthy Controls
Time frame: At time of enrollment (single time point)
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.
Comparison of Serum IL-41 Levels Between Patients With Sepsis or Septic Shock and Healthy Controls
Time frame: At time of enrollment (single time point)
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.
1 secondary outcome
Correlation Between IL-40 and IL-41 Levels in All Participants
Time frame: At time of enrollment (single time point)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Background: PubMed 34599691Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.
- Background: PubMed 39819454Cai S, Li X, Zhang C, Jiang Y, Liu Y, He Z, Ma S, Yao Y, Wong CK, Wu G, Gao X. Inhibition of Interleukin-40 prevents multi-organ damage during sepsis by blocking NETosis. Crit Care. 2025 Jan 16;29(1):29. doi: 10.1186/s13054-025-05257-2.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical considerations, limited sample size, and absence of a formal data-sharing infrastructure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Melahat Yalcin Solak at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MELAHAT YALÇIN SOLAK, Medical Doctor (+905326479195, melosyalcin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Serum IL-40 Levels Between Patients With Sepsis or Septic Shock and Healthy Controls (time frame: At time of enrollment (single time point)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06963541, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.