Phoenixin-14 Downregulation in Sepsis

NCT07356739 | Completed

• 1 other identifier: 23376
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Sepsis is a leading cause of morbidity and mortality in intensive care units (ICUs) worldwide, accounting for millions of deaths annually. Despite the use of established biomarkers such as procalcitonin, C-reactive protein (CRP), and interleukin-6 (IL-6), their predictive accuracy for mortality remains suboptimal. Phoenixin-14 (PNX-14), a neuropeptide with demonstrated anti-inflammatory and antioxidant effects in preclinical studies, has not been extensively investigated in the context of sepsis. This study aimed to evaluate the prognostic value of serum PNX-14 levels and gene expression in predicting hospital mortality among ICU patients with sepsis. Methods: This prospective observational cohort study included 77 adult patients admitted to a tertiary ICU with a diagnosis of septic shock between March and November 2024. Patients under 18 years, pregnant women, and those with chronic steroid use, immunosuppression, malignancy, severe liver disease, or early discharge/death within 72 hours of diagnosis were excluded. Upon ICU admission, demographic and clinical data were recorded, including Acute Physiology and Chronic Health Evaluation II (APACHE II) and Sequential Organ Failure Assessment (SOFA) scores. Serum PNX-14, CRP, procalcitonin, IL-1β, IL-6, tumor necrosis factor-α (TNF-α), and IL-10 levels were measured using ELISA. Gene expression levels of PNX-14 were quantified via real-time PCR. The primary endpoint was hospital mortality; secondary endpoints included associations and correlations between PNX-14 levels, inflammatory markers, and severity scores.

Conditions

Sepsis - to Reduce Mortality in the Intensive Care Unit; Sepsis Biomarker; Phoenixin-14 Molecular Downregulation

Outcome Measures

Primary Outcomes (2)

• The association between PNX14 levels (serum ELISA) and intensive care mortality in patients with sepsis/septic shock

  EEndpoints: to evaluate supression of PNX-14 (serum ELISA) at the molecular level in patients with sepsis and their potential as a translational biomarker. The correlation between PNX14 levels and those of CRP, procalcitonin, IL-1β, IL-6, IL-10, and TNF-α levels were also examined (serum ELISA) as part of the endpoints.

  Blood samples were collected within 2 hours of ICU admission, mortality is taken through study completion, an average of 1 year.

• the relationship between PNX14 levels and in-hospital mortality in patients with sepsis or septic shock

  within 2 hours of ICU admission

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 18 admitted to our tertiary intensive care unit with diagnoses of sepsis and/or septic shock

You may qualify if:

• Patients over the age of 18 admitted to our tertiary intensive care unit with diagnoses of sepsis and/or septic shock

You may not qualify if:

• Patients under the age of 18, patients who were discharged/transferred or died within 72 hours after being diagnosed with sepsis, patients/relatives who refused to participate in the study, pregnant women, patients with chronic steroid use, endocrinopathy, liver disease, malignancy, or a history of immunosuppression.

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Firat University Hospital

Elâzığ, 23100, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: January 21, 2026
• Study Start: April 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)