Intensive Care Unit PatientsTR-SOFA2NCT07338240
SOFA-2 Score in Turkish ICUs
An observational study of Intensive Care Unit Patients and Critically Ill Intensive Care Unit Patients, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate how well a new scoring system called the Sequential Organ Failure Assessment-2 (SOFA-2) works in adult intensive care units in Türkiye. SOFA-2 is designed to measure the severity of organ dysfunction in critically ill patients using routinely collected clinical and laboratory data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Patients, Critically Ill Intensive Care Unit Patients
- How many people
- 5,200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jan 2026to Jul 2026
- How long will I take part?
- 60 Days
- 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: The study population consists of adult patients admitted to participating intensive care units across Türkiye. Eligible participants are critically ill adults who require intensive care monitoring and treatment and remain in the intensive care unit for more than 24 hours. The study includes a broad and heterogeneous ICU population reflecting routine clinical practice and does not target a specific dise
Who may be able to join
- Adults aged 18 years or older
- Admission to a participating intensive care unit in Türkiye
- Intensive care unit stay longer than 24 hours
Who cannot join
- Patients younger than 18 years
- Pregnant patients
- Organ donors
- Patients with unknown intensive care unit discharge outcomes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences Turkey, İzmir School of Medicine, Dr. Suat Seren Chest Disease and Thoracic Surgery Training and Research Hospital, Intensive Care Unit
Izmir, İzmir, 35110
Süleyman Yıldırım, Assoc. Prof., 05057143243, deu.syldrm@gmail.com
About this study
Official title: Real-Time Validation and Feasibility of the SOFA-2 Score in Adult Intensive Care Units in Türkiye (TR-SOFA2): A Multicenter Prospective Observational Study
This study aims to evaluate how well a new scoring system called the Sequential Organ Failure Assessment-2 (SOFA-2) works in adult intensive care units in Türkiye.
SOFA-2 is designed to measure the severity of organ dysfunction in critically ill patients using routinely collected clinical and laboratory data. It is an updated version of the original SOFA score and reflects modern intensive care practices.
Read more
In this multicenter observational study, adult patients admitted to participating intensive care units will be followed during their ICU stay. SOFA and SOFA-2 scores will be calculated during the first 24 hours of admission, and in patients with longer stays, additional scores will be recorded. No additional tests or treatments will be performed as part of the study.
The main goal of the study is to examine the relationship between SOFA-2 scores and intensive care unit mortality. The results are expected to help clinicians better assess disease severity and outcomes in critically ill patients.
Read the detailed description
This is a multicenter, prospective, observational study designed to evaluate the feasibility and prognostic performance of the Sequential Organ Failure Assessment-2 (SOFA-2) score in adult intensive care units across Türkiye.
Adult patients aged 18 years or older who are admitted to participating intensive care units and remain in the ICU for more than 24 hours will be eligible for inclusion. Pregnant patients, organ donors, patients younger than 18 years, and those with unknown ICU discharge outcomes will be excluded.
Demographic characteristics, reasons for ICU admission, comorbid conditions, and routinely collected clinical and laboratory data will be prospectively recorded using standardized case report forms. SOFA and SOFA-2 scores will be calculated based on data obtained during the first 24 hours following ICU admission. For patients with an ICU stay longer than 72 hours, additional SOFA and SOFA-2 scores will be recorded at 72 hours.
Patients will be followed until ICU discharge or death. No study-specific interventions, additional diagnostic procedures, or changes to standard clinical management will be implemented as part of the study.
The study will assess the feasibility of real-time SOFA-2 score calculation, evaluate its association with ICU mortality, and compare its prognostic performance with the original SOFA score. Analyses will account for the multicenter structure of the study and variations across participating intensive care units.
- Keywords
- SOFA-2 Score, Critical Illness, ICU Mortality, Prognostic Scoring System
- Medical subject headings
- 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 |
|---|---|---|
| Adult ICU Patients | This cohort consists of adult patients aged 18 years or older who are admitted to participating intensive care units in Türkiye and remain in the ICU for more than 24 hours. Patients are enrolled prospectively and followed from ICU admission until ICU discharge or death. Clinical and laboratory data routinely collected during standard care are used to calculate SOFA and SOFA-2 scores. No study-specific interventions, additional diagnostic procedures, or changes to standard clinical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between 24-Hour SOFA-2 Score and ICU Mortality
The association between the total SOFA-2 score calculated within the first 24 hours of intensive care unit admission and all-cause ICU mortality. Higher scores show worse outcomes.
Measured: 60 days after ICU admission
Secondary outcomes (1)
Reclassification Performance of SOFA-2 Compared With SOFA
Comparison of patient risk classification between SOFA and SOFA-2 scores with respect to ICU mortality.Higher scores show worse outcomes.
Measured: 60 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start19 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit PatientsStudies 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
- 5,200 participants (estimated)
- Target duration
- 60 Days
Sponsor and investigators
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cenk Kirakli, M.D., Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338240
- Sponsor's protocol ID
- IGHCEAH-ICU-8
- Acronym
- TR-SOFA2
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 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: De-identified individual participant data related to baseline demographics, ICU admission characteristics, SOFA and SOFA-2 scores, and ICU outcomes that underlie the results reported in the primary publication will be shared. No direct identifiers or protected health information will be included.
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 41159833Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
PubMed 8844239Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.
PubMed 9824069
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
- Real-Time Validation and Feasibility of the SOFA-2 Score in Adult Intensive Care Units in Türkiye (TR-SOFA2): A Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07338240
- Acronym / sponsor ID
- TR-SOFA2 / IGHCEAH-ICU-8
- Keywords
- SOFA-2 Score, Critical Illness, ICU Mortality, Prognostic Scoring System
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,200 participants (estimated)
- Lead sponsor
- Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research HospitalUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 13 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.
This study aims to evaluate how well a new scoring system called the Sequential Organ Failure Assessment-2 (SOFA-2) works in adult intensive care units in Türkiye.
SOFA-2 is designed to measure the severity of organ dysfunction in critically ill patients using routinely collected clinical and laboratory data. It is an updated version of the original SOFA score and reflects modern intensive care practices.
In this multicenter observational study, adult patients admitted to participating intensive care units will be followed during their ICU stay. SOFA and SOFA-2 scores will be calculated during the first 24 hours of admission, and in patients with longer stays, additional scores will be recorded. No additional tests or treatments will be performed as part of the study.
The main goal of the study is to examine the relationship between SOFA-2 scores and intensive care unit mortality. The results are expected to help clinicians better assess disease severity and outcomes in critically ill patients.
Detailed description
This is a multicenter, prospective, observational study designed to evaluate the feasibility and prognostic performance of the Sequential Organ Failure Assessment-2 (SOFA-2) score in adult intensive care units across Türkiye.
Adult patients aged 18 years or older who are admitted to participating intensive care units and remain in the ICU for more than 24 hours will be eligible for inclusion. Pregnant patients, organ donors, patients younger than 18 years, and those with unknown ICU discharge outcomes will be excluded.
Demographic characteristics, reasons for ICU admission, comorbid conditions, and routinely collected clinical and laboratory data will be prospectively recorded using standardized case report forms. SOFA and SOFA-2 scores will be calculated based on data obtained during the first 24 hours following ICU admission. For patients with an ICU stay longer than 72 hours, additional SOFA and SOFA-2 scores will be recorded at 72 hours.
Patients will be followed until ICU discharge or death. No study-specific interventions, additional diagnostic procedures, or changes to standard clinical management will be implemented as part of the study.
The study will assess the feasibility of real-time SOFA-2 score calculation, evaluate its association with ICU mortality, and compare its prognostic performance with the original SOFA score. Analyses will account for the multicenter structure of the study and variations across participating intensive care units.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult ICU Patients | – | –This cohort consists of adult patients aged 18 years or older who are admitted to participating intensive care units in Türkiye and remain in the ICU for more than 24 hours. Patients are enrolled prospectively and followed from ICU admission until ICU discharge or death. Clinical and laboratory data routinely collected during standard care are used to calculate SOFA and SOFA-2 scores. No study-specific interventions, additional diagnostic procedures, or changes to standard clinical |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients admitted to participating intensive care units across Türkiye. Eligible participants are critically ill adults who require intensive care monitoring and treatment and remain in the intensive care unit for more than 24 hours. The study includes a broad and heterogeneous ICU population reflecting routine clinical practice and does not target a specific dise
Key inclusion criteria (3 listed)
- Adults aged 18 years or older
- Admission to a participating intensive care unit in Türkiye
- Intensive care unit stay longer than 24 hours
Key exclusion criteria (4 listed)
- Patients younger than 18 years
- Pregnant patients
- Organ donors
- Patients with unknown intensive care unit discharge outcomes
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
Association Between 24-Hour SOFA-2 Score and ICU Mortality
Time frame: 60 days after ICU admission
The association between the total SOFA-2 score calculated within the first 24 hours of intensive care unit admission and all-cause ICU mortality. Higher scores show worse outcomes.
1 secondary outcome
Reclassification Performance of SOFA-2 Compared With SOFA
Time frame: 60 days after ICU admission
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 21 Jan 2026.
- Background: 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.
- Background: PubMed 8844239Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
- Background: PubMed 9824069Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.
- Individual participant dataSharing planned: Yes. De-identified individual participant data related to baseline demographics, ICU admission characteristics, SOFA and SOFA-2 scores, and ICU outcomes that underlie the results reported in the primary publication will be shared. No direct identifiers or protected health information will be included.
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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.
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 Intensive Care Unit Patients and Critically Ill Intensive Care Unit Patients, run by Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital 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 3 inclusion and 4 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: looking for participants now, 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?
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 Süleyman Yıldırım, Assoc. Prof. (+905057143243, deu.syldrm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between 24-Hour SOFA-2 Score and ICU Mortality (time frame: 60 days after ICU admission). 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 NCT07338240, which also lists 3 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 21 Jan 2026.