Effect of Sepsis Adsorption Column on Syndecan-1 and Mortality

NCT07033910 | Completed FDA Device

• 2 other identifiers: GulhaneSM 2023/93001
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Syndecan 1; Extracorporeal Sepsis Adsorption Column

Keywords

Cytokine filter; intensive care unit; Interleukin-6; sepsis; sepsis adsorption column; Syndecan-1

Outcome Measures

Primary Outcomes (1)

• Plasma Syndecan-1 Level Following Sepsis Adsorption Column Treatment

  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..

  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.

Secondary Outcomes (3)

• Change in Serum Lactate Levels

  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.

• Post-Treatment Plasma Interleukin-6 (IL-6) Levels

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

• Vasopressor/Inotrope Dose Correlation With Syndecan-1 Levels

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

Study Arms (2)

Adsorption Column Used

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.

Device: sepsis adsorption column

Standard Sepsis Treatment Only

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.

Interventions

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.

Adsorption Column Used

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Gülhane Training and Research Hospital, Department of Internal Medicine Intensive Care Unit

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oral MENTEŞ: lead

Study Sites (1)

Gülhane Training and Research Hospital

Ankara, Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (21)

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Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

The remaining 8-10 mL venous blood samples from the routine blood collection of the patients included in the study were collected in red capped tubes. The blood samples were centrifuged at 4000 rpm for 10 minutes and serum was separated. The serum samples were stored in clean and dry ependorf tubes at -80°C until analysis.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• HUSEYIN L YAMANEL, MD, PhD

  GULHANE SM

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Dr. Oral MENTEŞ (Chest Diseases and Intensive Care Specialist)

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: June 24, 2025
• Study Start: May 25, 2023
• Primary Completion: June 9, 2024
• Study Completion: June 9, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for sharing starting 6 months after the publication of the primary study results and will remain available for a period of 5 years thereafter.
• Access Criteria: De-identified participant data will be shared with researchers who submit a clear research plan. Data sharing requires approval by the study team and signing a data use agreement to protect privacy.

Locations

TU (1)