SepsisNCT07906561
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
An observational study of Sepsis and Septic Shock, run by Inonu University.
Trial summary
The purpose of this study is to find out whether blood levels of two proteins, GDF-15 and LGALS3BP, measured at intensive care unit admission and at 72 hours, can help predict survival and organ dysfunction in adult patients with sepsis or septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Serum GDF-15 and LGALS3BP Measurement
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with sepsis or septic shock admitted to the Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center.
Who may be able to join
- Age 18 years or older
- Sepsis or septic shock according to Sepsis-3 criteria
- Enrollment possible within 24 hours of ICU admission
Who cannot join
- Chronic heart failure (NYHA class III-IV)
- Stage 4-5 chronic kidney disease or maintenance dialysis
- Active malignancy or chemotherapy/radiotherapy within the last 6 months
- Pregnancy
- Expected death or discharge within 24 hours of ICU admission
- Refusal to participate -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prognostic Value of Serum GDF-15 and LGALS3BP Levels in Patients With Sepsis: A Prospective Cohort Study
The purpose of this study is to find out whether blood levels of two proteins, GDF-15 and LGALS3BP, measured at intensive care unit admission and at 72 hours, can help predict survival and organ dysfunction in adult patients with sepsis or septic shock. Blood samples are collected together with routine laboratory tests, without additional needle sticks. The study does not change patient treatment.
Read the detailed description
Sepsis is a heterogeneous syndrome with high mortality in intensive care units. Current prognostic tools such as SOFA, APACHE II, lactate, and procalcitonin partly reflect disease severity but do not directly capture the underlying cellular stress and immune activation. GDF-15 is a stress-responsive cytokine associated with organ dysfunction in critical illness, and LGALS3BP is a glycoprotein linked to innate immunity that is elevated in the plasma of septic patients. Because these markers represent different pathophysiological pathways, their combined assessment may provide stronger prognostic information than either alone.
This single-center, prospective, observational cohort study is conducted in the Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center, Malatya, Turkey. Adult patients with sepsis or septic shock according to Sepsis-3 criteria are enrolled within 24 hours of ICU admission. Informed consent is obtained from the patient or a legally authorized representative, with confirmation from the patient once consciousness is regained.
Blood samples are collected within the first 24 hours of ICU admission (T0) and at 72 hours (plus or minus 6 hours; T1), simultaneously with routine laboratory sampling. Serum is separated, stored at -80 degrees Celsius, and analyzed in batch at the end of the study using commercial ELISA kits. Clinical data include demographics, infection source, SOFA score (T0 and T1), APACHE II score, Charlson Comorbidity Index, lactate, procalcitonin, vasopressor requirement and dose, mechanical ventilation, and ICU and hospital length of stay.
The primary outcomes are the associations of T0 and T1 serum GDF-15 and LGALS3BP levels with 28-day mortality and with the change in SOFA score. Receiver operating characteristic analysis with DeLong comparison will assess whether the combined panel outperforms each marker alone. The planned sample size is 150 patients.
- Conditions
- Sepsis, Septic Shock
- Being tested
- Serum GDF-15 and LGALS3BP Measurement
- Keywords
- GDF-15, Growth Differentiation Factor 15, LGALS3BP, Biomarkers, SOFA Score, Intensive Care Unit
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum GDF-15 and LGALS3BP MeasurementDiagnostic test
Serum GDF-15 and LGALS3BP levels measured by ELISA in blood samples collected within 24 hours of ICU admission and at 72 hours, simultaneously with routine laboratory sampling.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Sepsis or Septic Shock | Adult patients with sepsis or septic shock according to Sepsis-3 criteria, enrolled within 24 hours of ICU admission, with serum GDF-15 and LGALS3BP measured at admission and at 72 hours. Receives: Diagnostic Test: Serum GDF-15 and LGALS3BP Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum GDF-15 Concentration
Serum growth differentiation factor-15 (GDF-15) concentration measured by enzyme-linked immunosorbent assay (ELISA), in pg/mL.
Measured: Within 24 hours of ICU admission and at 72 hours
Serum LGALS3BP Concentration
Serum galectin-3-binding protein (LGALS3BP) concentration measured by enzyme-linked immunosorbent assay (ELISA), in µg/mL.
Measured: Within 24 hours of ICU admission and at 72 hours
28-Day All-Cause Mortality
Number of participants who died from any cause within 28 days of ICU admission.
Measured: 28 days after ICU admission
Change in SOFA Score
Change in Sequential Organ Failure Assessment (SOFA) score from ICU admission to 72 hours. The SOFA score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction.
Measured: From ICU admission to 72 hours
Secondary outcomes (8)
Change in Serum GDF-15 Concentration
Change in serum GDF-15 concentration measured by ELISA between ICU admission and 72 hours, in pg/mL.
Measured: From ICU admission to 72 hours
Change in Serum LGALS3BP Concentration
Change in serum LGALS3BP concentration measured by ELISA between ICU admission and 72 hours, in µg/mL.
Measured: From ICU admission to 72 hours
Area Under the ROC Curve of the Combined GDF-15 and LGALS3BP Panel for 28-Day Mortality
Area under the receiver operating characteristic curve (range 0 to 1) of the combined serum GDF-15 and LGALS3BP panel for predicting 28-day all-cause mortality.
Measured: 28 days after ICU admission
APACHE II Score
Acute Physiology and Chronic Health Evaluation II score at ICU admission. Scores range from 0 to 71, with higher scores indicating greater disease severity.
Measured: Within 24 hours of ICU admission
Number of Participants Requiring Vasopressor Therapy
Number of participants requiring vasopressor therapy to maintain mean arterial pressure.
Measured: From ICU admission to 72 hours
Duration of Invasive Mechanical Ventilation
Duration of invasive mechanical ventilation, in days.
Measured: From ICU admission to extubation or death, assessed up to 28 days
ICU Length of Stay
Length of intensive care unit stay, in days.
Measured: From ICU admission to ICU discharge, assessed up to 28 days
In-Hospital All-Cause Mortality
Number of participants who died from any cause during the hospital stay.
Measured: From ICU admission to hospital discharge, assessed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Belin Ozer, Inonu University
- Investigators
- Ayşe Belin Özer, MD, Prof., Principal investigator, Intensive Care Unit, Inonu University turgut Ozal Medical Center,Malatya, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906561
- Sponsor's protocol ID
- 11173
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality and the absence of consent for data sharing beyond the study team. Aggregate results will be published in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Serum GDF-15 and LGALS3BP Levels in Patients With Sepsis: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07906561
- Acronym / sponsor ID
- 11173
- Conditions
- Sepsis, Septic Shock
- Keywords
- GDF-15, Growth Differentiation Factor 15, LGALS3BP, Biomarkers, SOFA Score, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Oct 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.
The purpose of this study is to find out whether blood levels of two proteins, GDF-15 and LGALS3BP, measured at intensive care unit admission and at 72 hours, can help predict survival and organ dysfunction in adult patients with sepsis or septic shock. Blood samples are collected together with routine laboratory tests, without additional needle sticks. The study does not change patient treatment.
Detailed description
Sepsis is a heterogeneous syndrome with high mortality in intensive care units. Current prognostic tools such as SOFA, APACHE II, lactate, and procalcitonin partly reflect disease severity but do not directly capture the underlying cellular stress and immune activation. GDF-15 is a stress-responsive cytokine associated with organ dysfunction in critical illness, and LGALS3BP is a glycoprotein linked to innate immunity that is elevated in the plasma of septic patients. Because these markers represent different pathophysiological pathways, their combined assessment may provide stronger prognostic information than either alone.
This single-center, prospective, observational cohort study is conducted in the Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center, Malatya, Turkey. Adult patients with sepsis or septic shock according to Sepsis-3 criteria are enrolled within 24 hours of ICU admission. Informed consent is obtained from the patient or a legally authorized representative, with confirmation from the patient once consciousness is regained.
Blood samples are collected within the first 24 hours of ICU admission (T0) and at 72 hours (plus or minus 6 hours; T1), simultaneously with routine laboratory sampling. Serum is separated, stored at -80 degrees Celsius, and analyzed in batch at the end of the study using commercial ELISA kits. Clinical data include demographics, infection source, SOFA score (T0 and T1), APACHE II score, Charlson Comorbidity Index, lactate, procalcitonin, vasopressor requirement and dose, mechanical ventilation, and ICU and hospital length of stay.
The primary outcomes are the associations of T0 and T1 serum GDF-15 and LGALS3BP levels with 28-day mortality and with the change in SOFA score. Receiver operating characteristic analysis with DeLong comparison will assess whether the combined panel outperforms each marker alone. The planned sample size is 150 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Sepsis or Septic Shock | – | Diagnostic Test: Serum GDF-15 and LGALS3BP MeasurementAdult patients with sepsis or septic shock according to Sepsis-3 criteria, enrolled within 24 hours of ICU admission, with serum GDF-15 and LGALS3BP measured at admission and at 72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with sepsis or septic shock admitted to the Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Sepsis or septic shock according to Sepsis-3 criteria
- Enrollment possible within 24 hours of ICU admission
Key exclusion criteria (6 listed)
- Chronic heart failure (NYHA class III-IV)
- Stage 4-5 chronic kidney disease or maintenance dialysis
- Active malignancy or chemotherapy/radiotherapy within the last 6 months
- Pregnancy
- Expected death or discharge within 24 hours of ICU admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum GDF-15 and LGALS3BP MeasurementSerum GDF-15 and LGALS3BP levels measured by ELISA in blood samples collected within 24 hours of ICU admission and at 72 hours, simultaneously with routine laboratory sampling. | Diagnostic test | Patients With Sepsis or Septic Shock |
Primary outcome
Serum GDF-15 Concentration
Time frame: Within 24 hours of ICU admission and at 72 hours
Serum growth differentiation factor-15 (GDF-15) concentration measured by enzyme-linked immunosorbent assay (ELISA), in pg/mL.
Serum LGALS3BP Concentration
Time frame: Within 24 hours of ICU admission and at 72 hours
Serum galectin-3-binding protein (LGALS3BP) concentration measured by enzyme-linked immunosorbent assay (ELISA), in µg/mL.
28-Day All-Cause Mortality
Time frame: 28 days after ICU admission
Number of participants who died from any cause within 28 days of ICU admission.
Change in SOFA Score
Time frame: From ICU admission to 72 hours
Change in Sequential Organ Failure Assessment (SOFA) score from ICU admission to 72 hours. The SOFA score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction.
8 secondary outcomes
Change in Serum GDF-15 Concentration
Time frame: From ICU admission to 72 hours
Change in Serum LGALS3BP Concentration
Time frame: From ICU admission to 72 hours
Area Under the ROC Curve of the Combined GDF-15 and LGALS3BP Panel for 28-Day Mortality
Time frame: 28 days after ICU admission
APACHE II Score
Time frame: Within 24 hours of ICU admission
Number of Participants Requiring Vasopressor Therapy
Time frame: From ICU admission to 72 hours
Duration of Invasive Mechanical Ventilation
Time frame: From ICU admission to extubation or death, assessed up to 28 days
ICU Length of Stay
Time frame: From ICU admission to ICU discharge, assessed up to 28 days
In-Hospital All-Cause Mortality
Time frame: From ICU admission to hospital discharge, assessed up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality and the absence of consent for data sharing beyond the study team. Aggregate results will be published in a peer-reviewed journal.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Ayşe Belin Özer, MD, Prof. principal investigator
Intensive Care Unit, Inonu University turgut Ozal Medical Center,Malatya, Türkiye
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Inonu University.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Göksel Aydoğan, MD (+905342428048, drgoksel5533@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum GDF-15 Concentration (time frame: Within 24 hours of ICU admission and at 72 hours). The study lists 4 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 30 Oct 2026.