The Effect of Extracorporeal Sepsis Adsorption Column Use on Plasma Syndecan-1 Level and Mortality in Sepsis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Plasma Syndecan-1 Level Following Sepsis Adsorption Column Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Plasma Syndecan-1 Level Following Sepsis Adsorption Column Treatment
时间窗: 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..
次要结局
- 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.)
研究者
Oral MENTEŞ
Specialist Dr. Oral MENTEŞ (Chest Diseases and Intensive Care Specialist)
Gulhane School of Medicine