SOFA-2 for predicting death and measuring sepsis rates in Turkish ICUs
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 team will test whether the SOFA-2 score better predicts 30-day death and how common Sepsis-3 and septic shock are in adults admitted to Turkish intensive care units.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Marmara University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07300306 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective observational project enrolls consecutive adult ICU patients during a defined recruitment window to calculate organ dysfunction scores from the worst values in the first 24 hours. Researchers will compare the newer SOFA-2 score with the original SOFA score and record 30-day survival to determine predictive accuracy. A parallel point-prevalence component will capture Sepsis-3 and septic shock rates on a designated index day to estimate current frequency in Turkish ICUs. No experimental treatments are given; data come from routine clinical care including vital signs, labs, and organ-support details.
Who should consider this trial
Good fit: Adults aged 18 or older admitted to participating ICUs in Turkey during the study recruitment window who remain in the ICU for at least 24 hours are the ideal candidates.
Not a fit: Children, patients in pediatric, coronary, or cardiovascular surgery ICUs, organ-donation-only admissions, or patients with missing core data are unlikely to benefit from this validation effort.
Why it matters
Potential benefit: If successful, SOFA-2 could identify patients at high risk of death more accurately so clinicians can target care earlier and more appropriately.
How similar studies have performed: SOFA-2 has been validated in large international cohorts (reported in JAMA) but requires local validation in Turkey to confirm performance in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Istanbul
- Marmara University Pendik Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Mustafa Kemal Arslantaş, Prof. Dr.
- Email: mkarslantas@gmail.com
- Phone: +90 505 224 2119
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.