Skip to main content
OpenTrials
Completed

NCT Number: NCT07356739

Phoenixin-14 Downregulation in Sepsis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Firat University Hospital

Elâzığ, 23100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

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

    Time frame: within 2 hours of ICU admission

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.