Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Melahat Yalcin Solak

Conditions:

Sepsis

Septic Shock

Eligibility:

All Genders

18+ years

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,...

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 Asse...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

May 15 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06963541

Start Date

May 15 2025

End Date

December 31 2025

Last Update

May 9 2025

Active Locations (1)

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1

Harran University Faculty of Medicine, Department of Anesthesiology and Reanimation

Sanliurfa, Turkey (Türkiye), 630000