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NCT Number: NCT07033910

Effect of Sepsis Adsorption Column on Syndecan-1 and Mortality

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.

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Key information

Conditions

Sepsis Extracorporeal Sepsis Adsorption Column Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Syndecan 1 Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gülhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sepsis adsorption column

Device

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.

Primary outcomes

  1. Plasma Syndecan-1 Level Following Sepsis Adsorption Column Treatment

    Time frame: Measured within 24 hours after cytokine adsorption column application in the adsorption column used group and at 48-72 hours after ICU admission in the standard sepsis treatment only group.

    Plasma Syndecan-1 levels (ng/mL) will be measured in patients diagnosed with sepsis. In the adsorption column used group, Syndecan-1 levels will be assessed within the first 24 hours following the administration of the extracorporeal sepsis adsorption column (Biosky® MG350), which is applied within 48-72 hours after ICU admission. In the standard sepsis treatment only group, Syndecan-1 levels will be measured at the 48-72 hour mark after ICU admission. The primary outcome is the comparison of Syndecan-1 levels between the two groups to evaluate the effect of the adsorption column on endothelial injury..

Secondary outcomes

  1. Change in Serum Lactate Levels

    Time frame: From baseline (prior to adsorption column) to 24 hours after treatment in adsorption column used group; and from ICU admission to 48-72 hours in standard sepsis treatment only group.

    Comparison of median serum lactate levels (mmol/L) before and after treatment in both groups. The difference in lactate levels will be used to assess the metabolic response to treatment and organ perfusion improvement.

  2. Post-Treatment Plasma Interleukin-6 (IL-6) Levels

    Time frame: At 24 hours post-treatment in adsorption column used group and 48-72 hours in standard sepsis treatment only group.

    Measurement of plasma IL-6 levels (pg/mL) to evaluate the inflammatory response in both groups.

  3. Vasopressor/Inotrope Dose Correlation With Syndecan-1 Levels

    Time frame: At 24 hours post-treatment in adsorption column used group and 48-72 hours in standard sepsis treatment only group.

    Assessment of the correlation between plasma Syndecan-1 levels (ng/mL) and vasopressor/inotrope dose requirements (µg/kg/min).

Sponsors and collaborators

Lead sponsor

Oral MENTEŞ

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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