Sepsis - to Reduce Mortality in the Intensive Care UnitNCT07356739
Phoenixin-14 Downregulation in Sepsis
An observational study of Sepsis - to Reduce Mortality in the Intensive Care Unit and Sepsis Biomarker, run by Firat University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis - to Reduce Mortality in the Intensive Care Unit, Sepsis Biomarker, Phoenixin-14 Molecular Downregulation
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 Jun 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 admitted to our tertiary intensive care unit with diagnoses of sepsis and/or septic shock
Who may be able to join
- Patients over the age of 18 admitted to our tertiary intensive care unit with diagnoses of sepsis and/or septic shock
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: within 2 hours of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Apr 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis - to Reduce Mortality in the Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsum Altuntas, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356739
- Sponsor's protocol ID
- 23376
- Status last verified
- Jan 2026
- First submitted
- 15 Aug 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phoenixin-14 Downregulation as a Novel Prognostic Biomarker in Sepsis: Molecular and Clinical Evidence
- ClinicalTrials.gov ID
- NCT07356739
- Acronym / sponsor ID
- 23376
- Conditions
- Sepsis - to Reduce Mortality in the Intensive Care Unit, Sepsis Biomarker, Phoenixin-14 Molecular Downregulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 admitted to our tertiary intensive care unit with diagnoses of sepsis and/or septic shock
Key inclusion criteria (1 listed)
- Patients over the age of 18 admitted to our tertiary intensive care unit with diagnoses of sepsis and/or septic shock
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
the relationship between PNX14 levels and in-hospital mortality in patients with sepsis or septic shock
Time frame: within 2 hours of ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis - to Reduce Mortality in the Intensive Care Unit and Sepsis Biomarker, run by Firat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.