Effect of Sepsis Adsorption Column on Syndecan-1 and Mortality
NCT ID: NCT07033910
Last Updated: 2025-06-24
Study Results
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Basic Information
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COMPLETED
91 participants
OBSERVATIONAL
2023-05-25
2024-06-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
sepsis adsorption column
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.
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.
No interventions assigned to this group
Interventions
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sepsis adsorption column
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.
Eligibility Criteria
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Inclusion Criteria
* Patients over 18 years of age
* Patients diagnosed with sepsis/septic shock
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Oral MENTEŞ
OTHER
Responsible Party
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Oral MENTEŞ
Specialist Dr. Oral MENTEŞ (Chest Diseases and Intensive Care Specialist)
Principal Investigators
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HUSEYIN L YAMANEL, MD, PhD
Role: STUDY_DIRECTOR
GULHANE SM
Locations
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Gülhane Training and Research Hospital
Ankara, Ankara, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
Gotte M. Syndecans in inflammation. FASEB J. 2003 Apr;17(6):575-91. doi: 10.1096/fj.02-0739rev.
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.
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.
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.
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.
Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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001
Identifier Type: OTHER
Identifier Source: secondary_id
GulhaneSM 2023/93
Identifier Type: -
Identifier Source: org_study_id
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