IL-40 and IL-41 Levels in Sepsis, Septic Shock, and Healthy Individuals
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMelahat Yalcin Solak
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
No intervention; Observational study
Other interventionNo interventions are associated with either group. This is an observational study without experimental procedures.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Sepsis or Septic Shock Group1 intervention
Group B: Healthy Control Group1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)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.
Time frame
At time of enrollment (single time point)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Melahat Yalcin Solak
Lead sponsor
Harran University
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: