Validation of SOFA-2 for Mortality and Sepsis-3 Prevalence in Turkey
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,500 Participants
are grouped into 2 trial groupsGroup A: Primary Validation Cohort
Group B: Point Prevalence Cohort
Trial outcomes
Primary outcomes
1
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.
Time frame
30 daysSecondary 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.
Time frame
Index Day (24 hours)Other outcomes
1
Vasopressor-Free Days (VFD-28)
The number of days alive and free of vasopressor therapy within the first 28 days following admission.
Time frame
28 days2
Length of ICU Stay
The duration of stay in the Intensive Care Unit from admission to discharge or death.
Time frame
From date of admission until the date of discharge or death, assessed up to 90 days.3
Length of Hospital Stay
The total duration of hospitalization from admission to discharge or death.
Time frame
From date of admission until the date of discharge or death, assessed up to 90 days.Sponsors and contacts
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Source ClinicalTrials.gov