SepsisNCT07033910
Effect of Sepsis Adsorption Column on Syndecan-1 and Mortality
An observational study of Sepsis and Syndecan 1, run by Oral MENTEŞ at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Syndecan 1, Extracorporeal Sepsis Adsorption Column
- What is being tested?
- sepsis adsorption column
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 May 2023to 9 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gülhane Training and Research Hospital, Department of Internal Medicine Intensive Care Unit
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gülhane Training and Research Hospital
Ankara, Ankara, 06010
About this study
Official title: The Effect of Extracorporeal Sepsis Adsorption Column Use on Plasma Syndecan-1 Level and Mortality in Sepsis Patients
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.
Read the detailed description
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.
- Conditions
- Sepsis, Syndecan 1, Extracorporeal Sepsis Adsorption Column
- Being tested
- sepsis adsorption column
- Keywords
- Cytokine filter, intensive care unit, Interleukin-6, sepsis, sepsis adsorption column, Syndecan-1
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sepsis adsorption columnDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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.
Measured: 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
Measurement of plasma IL-6 levels (pg/mL) to evaluate the inflammatory response in both groups.
Measured: 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).
Measured: At 24 hours post-treatment in adsorption column used group and 48-72 hours in standard sepsis treatment only group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start25 May 2023
- Primary completion9 Jun 2024
- Study completion9 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oral MENTEŞ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oral MENTEŞ, Gulhane School of Medicine
- Investigators
- HUSEYIN L YAMANEL, MD, PhD, Study director, GULHANE SM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033910
- Sponsor's protocol ID
- GulhaneSM 2023/93
- Other IDs
- 001
- Status last verified
- Jun 2025
- First submitted
- 25 Apr 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26953518Lipowsky 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.
PubMed 21926341Gotte M. Syndecans in inflammation. FASEB J. 2003 Apr;17(6):575-91. doi: 10.1096/fj.02-0739rev.
PubMed 12665470Saunders 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.
PubMed 2494194Garcia-Alvarez M, Marik P, Bellomo R. Sepsis-associated hyperlactatemia. Crit Care. 2014 Sep 9;18(5):503. doi: 10.1186/s13054-014-0503-3.
PubMed 25394679Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
PubMed 23480440Ronco 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.
PubMed 36750878Hanasawa 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.
PubMed 12164799Jaber 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.
PubMed 9372979David 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.
PubMed 33471132Singer 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.
PubMed 26903338Piotti 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.
PubMed 33741039Dugar 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.
PubMed 31990655Evans 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.
PubMed 34599691Vivas 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.
PubMed 36343289
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Extracorporeal Sepsis Adsorption Column Use on Plasma Syndecan-1 Level and Mortality in Sepsis Patients
- ClinicalTrials.gov ID
- NCT07033910
- Acronym / sponsor ID
- GulhaneSM 2023/93
- Conditions
- Sepsis, Syndecan 1, Extracorporeal Sepsis Adsorption Column
- Keywords
- Cytokine filter, intensive care unit, Interleukin-6, sepsis, sepsis adsorption column, Syndecan-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Oral MENTEŞUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 9 Jun 2024 (actual)
- Study completion
- 9 Jun 2024 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adsorption Column Used | – | Device: sepsis adsorption columnConsisted 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gülhane Training and Research Hospital, Department of Internal Medicine Intensive Care Unit
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sepsis adsorption columnafter 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. | Device | Adsorption Column Used |
Primary outcome
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..
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 26953518Anand 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.
- Background: PubMed 21926341Lipowsky 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.
- Background: PubMed 12665470Gotte M. Syndecans in inflammation. FASEB J. 2003 Apr;17(6):575-91. doi: 10.1096/fj.02-0739rev.
- Background: PubMed 2494194Saunders 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.
- Background: PubMed 25394679Garcia-Alvarez M, Marik P, Bellomo R. Sepsis-associated hyperlactatemia. Crit Care. 2014 Sep 9;18(5):503. doi: 10.1186/s13054-014-0503-3.
- Background: PubMed 23480440Faix JD. Biomarkers of sepsis. Crit Rev Clin Lab Sci. 2013 Jan-Feb;50(1):23-36. doi: 10.3109/10408363.2013.764490.
- Background: PubMed 36750878Ronco 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.
- Background: PubMed 12164799Hanasawa 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.
- Background: PubMed 9372979Jaber 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.
- Background: PubMed 33471132David 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.
- Background: PubMed 26903338Singer 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.
- Background: PubMed 33741039Piotti 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HUSEYIN L YAMANEL, MD, PhD study director
GULHANE SM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Syndecan 1, run by Oral MENTEŞ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07033910, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.