IL-40 and IL-41 Levels in Sepsis, Septic Shock, and Healthy Individuals

NCT06963541 | Not Yet Recruiting

• 1 other identifier: HRÜ.27.01.25
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sepsis; Septic Shock; Inflammation; Biomarkers

Keywords

IL-40; IL-41; Cytokines; Critical Illness; Septic Shock; Sepsis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At time of enrollment (single time point)

Secondary Outcomes (1)

• Correlation Between IL-40 and IL-41 Levels in All Participants

  At time of enrollment (single time point)

Study Arms (2)

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.

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.

Other: No intervention; Observational study

Interventions

No intervention; Observational study OTHER

No interventions are associated with either group. This is an observational study without experimental procedures.

Healthy Control Group; Sepsis or Septic Shock Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Melahat Yalcin Solak: lead

Study Sites (1)

Harran University Faculty of Medicine, Department of Anesthesiology and Reanimation

Sanliurfa, 630000, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 34599691 BACKGROUND

• Cai 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.

  PMID: 39819454 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Inflammation; Critical Illness

Interventions

Observation

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

MELAHAT YALÇIN SOLAK, Medical Doctor

CONTACT

+905326479195; melosyalcin@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer doctor

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 9, 2025
• Study Start: May 15, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)