SepsisTURK-SOFA2NCT07300306
Validation of SOFA-2 for Mortality and Sepsis-3 Prevalence in Turkey
An observational study of Sepsis and Septic Shock, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to validate the effectiveness of the new SOFA-2 score in predicting mortality and to determine the current frequency of sepsis in adult patients admitted to Intensive Care Units (ICUs) in Turkey. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Critical Illness
- How many people
- 3,379 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 May 2026to 10 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (aged 18 years or older) admitted to adult Intensive Care Units (ICUs) in participating University Hospitals, Training and Research Hospitals, State Hospitals, and Private Hospitals across Turkey. The population includes consecutive admissions with various critical illness etiologies, excluding those admitted to coronary or cardiovascular surgery units.
Who may be able to join
- Patients aged 18 years or older.
- 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.
Who cannot join
- Patients younger than 18 years of age.
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul, 34912
About this study
Official title: Validation of the SOFA-2 Score for 30-Day Mortality in Intensive Care Units in Turkey and Determination of Sepsis-3 Prevalence - A Multicenter Hybrid Observational Study.
The goal of this observational study is to validate the effectiveness of the new SOFA-2 score in predicting mortality and to determine the current frequency of sepsis in adult patients admitted to Intensive Care Units (ICUs) in Turkey. The main questions it aims to answer are:
- 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?
Read more
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.
Read the detailed description
Background and Rationale Sepsis remains a leading cause of mortality in Intensive Care Units (ICUs) globally. The operational definition of sepsis (Sepsis-3) relies on the Sequential Organ Failure Assessment (SOFA) score. However, the original SOFA score, developed in 1996, predates modern critical care interventions such as High-Flow Nasal Cannula (HFNC), non-invasive ventilation, and contemporary vasopressor strategies. Consequently, the original score has limitations in accurately characterizing organ dysfunction in the modern ICU setting.
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
- Sepsis, Septic Shock, Critical Illness, Organ Dysfunction
- Keywords
- SOFA-2 Score, Sepsis-3, Intensive Care Unit, Mortality Prediction, Organ Failure Assessment, Validation Study
- Medical subject headings
- Sepsis, Shock, Septic, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
0-Day All-Cause Mortality
The vital status (alive or dead) of patients assessed at 30 days post-ICU admission. This measure is used to validate the predictive accuracy (discrimination and calibration) of the SOFA-2 score.
Measured: 30 days
Secondary outcomes (1)
Point Prevalence of Sepsis-3
The proportion of patients meeting the Third International Consensus Definitions for Sepsis (Sepsis-3) in the ICU on the designated index day.
Measured: Index Day (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start4 May 2026
- Primary completion23 Jun 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Marmara 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
- 3,379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kemal Arslantas, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300306
- Sponsor's protocol ID
- TURK-SOFA2
- Other IDs
- 09.2025.25-1065
- Acronym
- TURK-SOFA2
- Status last verified
- Aug 2026
- First submitted
- 10 Dec 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 Dec 16;334(23):2090-2103. doi: 10.1001/jama.2025.20516.
PubMed 41159833Weijs 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.
PubMed 29653538
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the SOFA-2 Score for 30-Day Mortality in Intensive Care Units in Turkey and Determination of Sepsis-3 Prevalence - A Multicenter Hybrid Observational Study.
- ClinicalTrials.gov ID
- NCT07300306
- Acronym / sponsor ID
- TURK-SOFA2 / TURK-SOFA2
- Conditions
- Sepsis, Septic Shock, Critical Illness, Organ Dysfunction
- Keywords
- SOFA-2 Score, Sepsis-3, Intensive Care Unit, Mortality Prediction, Organ Failure Assessment, Validation Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,379 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 23 Dec 2025 (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 goal of this observational study is to validate the effectiveness of the new SOFA-2 score in predicting mortality and to determine the current frequency of sepsis in adult patients admitted to Intensive Care Units (ICUs) in Turkey. The main questions it aims to answer are:
- 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
Background and Rationale Sepsis remains a leading cause of mortality in Intensive Care Units (ICUs) globally. The operational definition of sepsis (Sepsis-3) relies on the Sequential Organ Failure Assessment (SOFA) score. However, the original SOFA score, developed in 1996, predates modern critical care interventions such as High-Flow Nasal Cannula (HFNC), non-invasive ventilation, and contemporary vasopressor strategies. Consequently, the original score has limitations in accurately characterizing organ dysfunction in the modern ICU setting.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (aged 18 years or older) admitted to adult Intensive Care Units (ICUs) in participating University Hospitals, Training and Research Hospitals, State Hospitals, and Private Hospitals across Turkey. The population includes consecutive admissions with various critical illness etiologies, excluding those admitted to coronary or cardiovascular surgery units.
Key inclusion criteria (4 listed)
- Patients aged 18 years or older.
- 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.
Key exclusion criteria (6 listed)
- Patients younger than 18 years of age.
- 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.
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
0-Day All-Cause Mortality
Time frame: 30 days
The vital status (alive or dead) of patients assessed at 30 days post-ICU admission. This measure is used to validate the predictive accuracy (discrimination and calibration) of the SOFA-2 score.
1 secondary outcome
Point Prevalence of Sepsis-3
Time frame: Index Day (24 hours)
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 17 Aug 2026.
- Results publication: PubMed 41159833Ranzani 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 Dec 16;334(23):2090-2103. doi: 10.1001/jama.2025.20516.
- Results publication: PubMed 29653538Weijs 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 InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 and Septic Shock, run by Marmara 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 4 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: finished, as of the sponsor's last update on 17 Aug 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?
0-Day All-Cause Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07300306, which also lists 2 linked publications.
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 17 Aug 2026.