NCT07033910

Effect of Sepsis Adsorption Column on Syndecan-1 and Mortality

The Effect of Extracorporeal Sepsis Adsorption Column Use on Plasma Syndecan-1 Level and Mortality in Sepsis Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 91 (actual)
• Sponsor: Oral MENTEŞ · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This observational, cross-sectional, single-center study aims to investigate the effect of extracorporeal sepsis adsorption column therapy on plasma Syndecan-1 levels and clinical outcomes in patients with sepsis. The study was conducted in the Internal Medicine Intensive Care Unit of Gülhane Training and Research Hospital. Patients were divided into two groups: one group received standard sepsis treatment along with an extracorporeal adsorption column (Biosky® MG350), while the other group received only standard treatment. Clinical and laboratory parameters, including Syndecan-1 levels, were evaluated to assess the potential impact of the adsorption column on sepsis-related outcomes.

Detailed description

This single-center, cross-sectional, and observational study aims to evaluate the effect of extracorporeal sepsis adsorption column use on plasma Syndecan-1 levels and mortality in patients diagnosed with sepsis. The study was conducted in the Internal Medicine Intensive Care Unit of Gülhane Training and Research Hospital between May 25, 2023, and June 9, 2024. Patients who met the inclusion criteria were divided into two groups: Group 1: Patients received standard sepsis treatment, including fluid and antibiotic therapy according to the Surviving Sepsis Campaign 2021 Guidelines, in addition to extracorporeal sepsis adsorption column (Biosky® MG350) therapy applied within 48-72 hours of ICU admission. Group 2: Patients received only fluid and antibiotic therapy, without the use of a sepsis adsorption column. In both groups, plasma Syndecan-1 levels and various clinical and laboratory parameters were evaluated. These included APACHE II score, SOFA score, Charlson Comorbidity Index (CCI), comorbidities, infection focus, respiratory support status, vasopressor/inotrope requirement, laboratory values (including IL-6 and lactate), presence of acute kidney injury, need for hemodialysis, duration of ICU stay, and survival times. The only treatment-related difference between the groups was the use of the adsorption column. Clinical and laboratory data were collected at standardized time intervals in each group to allow for comparison. The study is designed to provide insight into whether the use of extracorporeal sepsis adsorption therapy has an observable impact on endothelial biomarkers such as Syndecan-1 and on patient outcomes in sepsis.

Conditions

• Sepsis
• Syndecan 1
• Extracorporeal Sepsis Adsorption Column

Interventions

Type	Name	Description
DEVICE	sepsis adsorption column	after the initiation of fluid and antibiotic therapy according to the Surviving Sepsis Campaign 2021 Guidelines, an additional routine sepsis adsorption column (Biosky® MG350) was used within 48-72 hours.

Timeline

• Start date: 2023-05-25
• Primary completion: 2024-06-09
• Completion: 2024-06-09
• First posted: 2025-06-24
• Last updated: 2025-06-24

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study