Validation of SOFA-2 for Mortality and Sepsis-3 Prevalence in Turkey
NCT ID: NCT07300306
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
2500 participants
OBSERVATIONAL
2026-01-15
2026-03-31
Brief Summary
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* Does the SOFA-2 score accurately predict 30-day mortality in ICU patients?
* What is the prevalence of Sepsis-3 and septic shock in Turkish ICUs?
Researchers will compare the new SOFA-2 score to the existing SOFA-1 score to see if the new score provides better predictive accuracy for patient outcomes.
Participants will not receive any experimental intervention. Researchers will collect data from routine medical care, including:
* Vital signs, laboratory test results, and details of organ support (such as mechanical ventilation or dialysis) during the first 24 hours of admission.
* Survival status at 30 days.
Detailed Description
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The recently updated SOFA-2 score (JAMA, 2025) addresses these shortcomings by revising scoring thresholds and incorporating modern respiratory and cardiovascular support modalities. While validated in large international cohorts, the SOFA-2 score requires local validation in Turkey to account for regional differences in patient demographics, genetics, and healthcare infrastructure before widespread clinical adoption.
Study Design This is a multicenter, prospective, hybrid observational study comprising two distinct components to maximize data utility while minimizing data collection burden:
Prospective Validation Cohort (Primary): A 7-day recruitment window will be established (e.g., January 2026). During this period, all consecutive adult patients (aged 18 and older) admitted to participating ICUs will be enrolled. Baseline organ dysfunction scores will be calculated using the worst physiological values recorded during the first 24 hours of admission. These patients will be followed up for 30-day all-cause mortality to validate the predictive performance (discrimination and calibration) of the SOFA-2 score compared to the original SOFA-1 score.
Point-Prevalence Cohort (Secondary): Within the 7-day window, a specific 24-hour period will be designated as the "Index Day." This cross-sectional component will include all patients present in the ICU at 08:00 AM on the index day, plus any new admissions over the subsequent 24 hours. This cohort will be used specifically to determine the point prevalence of Sepsis-3 and septic shock in Turkish ICUs, providing a snapshot of the current epidemiological burden compared to historical data.
Data Collection Methodology To ensure standardization and eliminate inter-rater variability, participating centers will not manually calculate scores. Instead, researchers will record raw physiological, laboratory, and therapeutic variables (e.g., PaO2, platelet count, exact vasopressor doses, Glasgow Coma Scale) into a central electronic Case Report Form (eCRF). The study algorithms will then centrally and automatically calculate SOFA-1, SOFA-2, APACHE II, and Sepsis-3 status for all patients. This approach ensures that the comparison between scoring systems is objective and mathematically consistent.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary Validation Cohort
Adult patients admitted to the ICU during the 7-day prospective recruitment window. Organ dysfunction scores are calculated within the first 24 hours to validate SOFA-2 for 30-day mortality.
No interventions assigned to this group
Point Prevalence Cohort
All adult patients present in the ICU on the designated single "Index Day" (08:00 to 08:00). Used specifically to determine the point prevalence of Sepsis-3 and septic shock.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Admitted to the Intensive Care Unit (ICU) during the specified study recruitment window.
* For the Validation Cohort: Patients staying in the ICU for at least 24 hours.
* For the Point Prevalence Cohort: Patients present in the ICU at 08:00 AM on the designated "Index Day" or admitted within the subsequent 24 hours.
Exclusion Criteria
* Patients admitted to Pediatric Intensive Care Units.
* Patients admitted to Coronary Care Units (CCU).
* Patients admitted to Cardiovascular Surgery Intensive Care Units.
* Patients admitted solely for the purpose of organ donation.
* Patients with missing core data components required for score calculation.
18 Years
ALL
No
Sponsors
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Marmara University
OTHER
Responsible Party
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Mustafa Kemal Arslantas
Professor of Anesthesiology and Anesthesiology and Reanimation
Locations
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Marmara University Pendik Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Fethi Gül, Assoc. Prof.
Role: primary
References
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Ranzani OT, Singer M, Salluh JIF, Shankar-Hari M, Pilcher D, Berger-Estilita J, Coopersmith CM, Juffermans NP, Laffey J, Reinikainen M, Neto AS, Tavares M, Timsit JF, Arias Lopez MDP, Arulkumaran N, Aryal D, Azoulay E, Celi LA, Chaudhuri D, De Lange D, De Waele J, Dos Santos CC, Du B, Einav S, Engelbrecht T, Fazla F, Ferrer R, Finazzi S, Fujii T, Gershengorn HB, Greene JD, Haniffa R, Hao S, Hasan MS, Hollenberg S, Ippolito M, Jung C, Kirov M, Kobari S, Lakbar I, Lipman J, Liu V, Liu X, Lobo SM, Magatti D, Martin GS, Metnitz B, Metnitz P, Myatra SN, Oczkowski S, Paiva JA, Paruk F, Pekkarinen PT, Piquilloud L, Polkki A, Prescott HC, Blaser AR, Rezende E, Robba C, Rochwerg B, Ruckly S, Samei R, Schenck EJ, Secombe P, Sendagire C, Siaw-Frimpong M, Simpkin AJ, Soares M, Summers C, Szczeklik W, Takala J, Tanaka S, Tricella G, Vincent JL, Wendon J, Zampieri FG, Rhodes A, Moreno R. Development and Validation of the Sequential Organ Failure Assessment (SOFA)-2 Score. JAMA. 2025 Oct 29:e2520516. doi: 10.1001/jama.2025.20516. Online ahead of print.
Weijs PJM. Route, early or energy? ... Protein improves protein balance in critically ill patients. Crit Care. 2018 Apr 14;22(1):91. doi: 10.1186/s13054-018-2015-z. No abstract available.
Related Links
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Related Info
Other Identifiers
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09.2025.25-1065
Identifier Type: OTHER
Identifier Source: secondary_id
TURK-SOFA2
Identifier Type: -
Identifier Source: org_study_id