Phoenixin-14 Downregulation in Sepsis

January 15, 2026 updated by: Gulsum Altuntas, Firat University

Phoenixin-14 Downregulation as a Novel Prognostic Biomarker in Sepsis: Molecular and Clinical Evidence

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

77

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The association between PNX14 levels (serum ELISA) and intensive care mortality in patients with sepsis/septic shock
Time Frame: Blood samples were collected within 2 hours of ICU admission, mortality is taken through study completion, an average of 1 year.
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
Time Frame: within 2 hours of ICU admission
within 2 hours of ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

August 15, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 23376

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis - to Reduce Mortality in the Intensive Care Unit

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe