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| ID | Type | Description | Link |
|---|---|---|---|
| 001 | Other Identifier | Buy Pharma Ecza Deposu San. Tic. Ltd. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Lactate Levels | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Gülhane Training and Research Hospital, Department of Internal Medicine Intensive Care Unit
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| Name | Affiliation | Role |
|---|---|---|
| HUSEYIN L YAMANEL, MD, PhD | GULHANE SM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gülhane Training and Research Hospital | Ankara | Ankara | 06010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26953518 | Background | Anand D, Ray S, Srivastava LM, Bhargava S. Evolution of serum hyaluronan and syndecan levels in prognosis of sepsis patients. Clin Biochem. 2016 Jul;49(10-11):768-76. doi: 10.1016/j.clinbiochem.2016.02.014. Epub 2016 Mar 4. | |
| 21926341 | Background | Lipowsky HH, Gao L, Lescanic A. Shedding of the endothelial glycocalyx in arterioles, capillaries, and venules and its effect on capillary hemodynamics during inflammation. Am J Physiol Heart Circ Physiol. 2011 Dec;301(6):H2235-45. doi: 10.1152/ajpheart.00803.2011. Epub 2011 Sep 16. |
| Label | URL |
|---|---|
| Related Info | View source |
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The individual participant data (IPD) generated from this study, including de-identified demographic, clinical, laboratory, and outcome data, will be made available upon reasonable request. Data sharing will be facilitated after publication of the primary results to support further research in sepsis biomarkers and treatment effects. Data requests can be submitted to the corresponding author, who will review proposals for scientific merit and ethical compliance before granting access. Data will be shared under a data use agreement to ensure confidentiality and proper use.
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.
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.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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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.
| Post-Treatment Plasma Interleukin-6 (IL-6) Levels | Measurement of plasma IL-6 levels (pg/mL) to evaluate the inflammatory response in both groups. | 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 | Assessment of the correlation between plasma Syndecan-1 levels (ng/mL) and vasopressor/inotrope dose requirements (µg/kg/min). | At 24 hours post-treatment in adsorption column used group and 48-72 hours in standard sepsis treatment only group. |
| 12665470 | Background | Gotte M. Syndecans in inflammation. FASEB J. 2003 Apr;17(6):575-91. doi: 10.1096/fj.02-0739rev. |
| 2494194 | Background | Saunders S, Jalkanen M, O'Farrell S, Bernfield M. Molecular cloning of syndecan, an integral membrane proteoglycan. J Cell Biol. 1989 Apr;108(4):1547-56. doi: 10.1083/jcb.108.4.1547. |
| 25394679 | Background | Garcia-Alvarez M, Marik P, Bellomo R. Sepsis-associated hyperlactatemia. Crit Care. 2014 Sep 9;18(5):503. doi: 10.1186/s13054-014-0503-3. |
| 23480440 | Background | Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490. |
| 36750878 | Background | Ronco C, Chawla L, Husain-Syed F, Kellum JA. Rationale for sequential extracorporeal therapy (SET) in sepsis. Crit Care. 2023 Feb 7;27(1):50. doi: 10.1186/s13054-023-04310-2. |
| 12164799 | Background | Hanasawa K. Extracorporeal treatment for septic patients: new adsorption technologies and their clinical application. Ther Apher. 2002 Aug;6(4):290-5. doi: 10.1046/j.1526-0968.2002.00449.x. |
| 9372979 | Background | Jaber BL, Pereira BJ. Extracorporeal adsorbent-based strategies in sepsis. Am J Kidney Dis. 1997 Nov;30(5 Suppl 4):S44-56. doi: 10.1016/s0272-6386(97)90542-4. |
| 33471132 | Background | David S, Bode C, Putensen C, Welte T, Stahl K; EXCHANGE study group. Adjuvant therapeutic plasma exchange in septic shock. Intensive Care Med. 2021 Mar;47(3):352-354. doi: 10.1007/s00134-020-06339-1. Epub 2021 Jan 20. No abstract available. |
| 26903338 | Background | Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287. |
| 33741039 | Background | Piotti A, Novelli D, Meessen JMTA, Ferlicca D, Coppolecchia S, Marino A, Salati G, Savioli M, Grasselli G, Bellani G, Pesenti A, Masson S, Caironi P, Gattinoni L, Gobbi M, Fracasso C, Latini R; ALBIOS Investigators. Endothelial damage in septic shock patients as evidenced by circulating syndecan-1, sphingosine-1-phosphate and soluble VE-cadherin: a substudy of ALBIOS. Crit Care. 2021 Mar 19;25(1):113. doi: 10.1186/s13054-021-03545-1. |
| 31990655 | Background | Dugar S, Choudhary C, Duggal A. Sepsis and septic shock: Guideline-based management. Cleve Clin J Med. 2020 Jan;87(1):53-64. doi: 10.3949/ccjm.87a.18143. Epub 2020 Jan 2. |
| 34599691 | Background | Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available. |
| 36343289 | Result | Vivas MC, Villamarin Guerrero HF, Tascon AJ, Valderrama-Aguirre A. Plasma interleukin-6 levels correlate with survival in patients with bacterial sepsis and septic shock. Interv Med Appl Sci. 2021 Aug 2;11(4):224-230. doi: 10.1556/1646.2020.00006. eCollection 2021 Aug. |
| 30448517 | Result | Hawchar F, Laszlo I, Oveges N, Trasy D, Ondrik Z, Molnar Z. Extracorporeal cytokine adsorption in septic shock: A proof of concept randomized, controlled pilot study. J Crit Care. 2019 Feb;49:172-178. doi: 10.1016/j.jcrc.2018.11.003. Epub 2018 Nov 10. |
| 37259160 | Result | Becker S, Lang H, Vollmer Barbosa C, Tian Z, Melk A, Schmidt BMW. Efficacy of CytoSorb(R): a systematic review and meta-analysis. Crit Care. 2023 May 31;27(1):215. doi: 10.1186/s13054-023-04492-9. |
| 29084247 | Result | Schadler D, Pausch C, Heise D, Meier-Hellmann A, Brederlau J, Weiler N, Marx G, Putensen C, Spies C, Jorres A, Quintel M, Engel C, Kellum JA, Kuhlmann MK. The effect of a novel extracorporeal cytokine hemoadsorption device on IL-6 elimination in septic patients: A randomized controlled trial. PLoS One. 2017 Oct 30;12(10):e0187015. doi: 10.1371/journal.pone.0187015. eCollection 2017. |
| 28589286 | Result | Friesecke S, Stecher SS, Gross S, Felix SB, Nierhaus A. Extracorporeal cytokine elimination as rescue therapy in refractory septic shock: a prospective single-center study. J Artif Organs. 2017 Sep;20(3):252-259. doi: 10.1007/s10047-017-0967-4. Epub 2017 Jun 6. |
| 31039813 | Result | Liu Z, Meng Z, Li Y, Zhao J, Wu S, Gou S, Wu H. Prognostic accuracy of the serum lactate level, the SOFA score and the qSOFA score for mortality among adults with Sepsis. Scand J Trauma Resusc Emerg Med. 2019 Apr 30;27(1):51. doi: 10.1186/s13049-019-0609-3. |
| 20181242 | Result | Nichol AD, Egi M, Pettila V, Bellomo R, French C, Hart G, Davies A, Stachowski E, Reade MC, Bailey M, Cooper DJ. Relative hyperlactatemia and hospital mortality in critically ill patients: a retrospective multi-centre study. Crit Care. 2010;14(1):R25. doi: 10.1186/cc8888. Epub 2010 Feb 24. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |