An observational study in Sepsis and Septic Shock, sponsored by Inonu University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Inonu University · Observational
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.
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.
895 studies on the registry are indexed under Shock, Septic; 212 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 312 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Inonu University is the lead sponsor of 391 studies on the registry; 93 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Sepsis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adult patients with sepsis or septic shock admitted to the Reanimation Intensive Care Unit of Inonu University Turgut Ozal Medical Center.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Diagnostic Test: Serum GDF-15 and LGALS3BP Measurement
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.
Serum GDF-15 Concentration
Serum growth differentiation factor-15 (GDF-15) concentration measured by enzyme-linked immunosorbent assay (ELISA), in pg/mL.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From ICU admission to 72 hours
Change in Serum GDF-15 Concentration
Change in serum GDF-15 concentration measured by ELISA between ICU admission and 72 hours, in pg/mL.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: Within 24 hours of ICU admission
Number of Participants Requiring Vasopressor Therapy
Number of participants requiring vasopressor therapy to maintain mean arterial pressure.
Time frame: From ICU admission to 72 hours
Duration of Invasive Mechanical Ventilation
Duration of invasive mechanical ventilation, in days.
Time frame: From ICU admission to extubation or death, assessed up to 28 days
ICU Length of Stay
Length of intensive care unit stay, in days.
Time frame: 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.
Time frame: From ICU admission to hospital discharge, assessed up to 28 days
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 138 non-industry observational studies under Shock, Septic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 54. This study's planned 24 months is below that.
Counting every sponsor, half of 148 studies reached it within 28 months; a quarter within 13 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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