Effect of Sepsis Adsorption Column on Syndecan-1 and Mortality

Oral MENTEŞ

Status: Completed

Conditions: Extracorporeal Sepsis Adsorption Column; Syndecan 1; Sepsis

Treatments: Device: sepsis adsorption column

Study type: Observational

Funder types: Other

Identifiers

NCT07033910

GulhaneSM 2023/93

001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients (Patient or relative) who accepted and signed the informed consent form and approved participation in the study
• Patients over 18 years of age
• Patients diagnosed with sepsis/septic shock

Exclusion criteria

• The Informed Voluntary Consent Form has not been signed by him/herself and his/her legal heir
• Patients with sepsis who died within the first 24 hours after admission to the internal medicine intensive care unit and within the first 24 hours after sepsis diagnosis and within the first 24 hours after administration of sepsis adsorption column
• Patients in Group-1 who could not receive extracorporeal hemoperfusion for any reason or who could not be started and completed

Trial design

91 participants in 2 patient groups

Adsorption Column Used

Description:

Consisted of 43 patients. Sepsis adsorption column used. 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. Clinical status, response to treatment, and plasma Syndecan-1 levels, among all laboratory variables, were evaluated within the first 24 hours following the filter application.

Treatment:

Device: sepsis adsorption column

Standard Sepsis Treatment Only

Description:

Consisted of 48 patients. Sepsis adsorption column not used. Patients receiving only fluid and antibiotic therapy, with clinical status, treatment response, and plasma Syndecan-1 levels, along with other laboratory variables, evaluated within the 48-72 hour period.