Septic ShockADSORP-VIPNCT07711197
Effects of Hemoadsorption on Vascular Integrity in Septic Shock
A study testing CytoSorb hemoadsorption and Standard Medical Therapy (SMT) in people with Septic Shock, run by Semmelweis University at 1 site in Hungary.
Trial summary
This study aims to investigate the effects of adjunctive CytoSorb hemoadsorption therapy versus standard medical treatment on endothelial dysfunction in patients with refractory septic shock. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- CytoSorb hemoadsorption and Standard Medical Therapy (SMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteHungary
- Study dates
- 1 Sep 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Septic shock as defined by Sepsis-3 criteria.
- Serum lactate levels >2 and <8 mmol/L at screening.
- Fluid unresponsiveness: Objectively confirmed via dynamic tests or fluid challenges following initial resuscitation.
- Vasopressor Dose Threshold: Norepinephrine base equivalent (NEE) dose > 0.5 µg/kg/min.
- Systemic corticosteroid treatment on board for at least 30 minutes.
- Tissue perfusion impairment: Persistently elevated serum lactate AND/OR prolonged capillary refill time (> 3 seconds) despite standard therapy.
Show all 11Show fewer
- Alternative causes of shock (e.g., obstructive or cardiogenic) must be ruled out using critical care ultrasonography (CCUS).
- Arterial, central venous catheters and an invasive hemodynamic device (PiCCO, Getinge) in place.
- Inclusion within a maximum of 12 hours after the onset of vasopressor need.
- High likelihood of a dysregulated immune response (PCT ≥ 5 ng/mL AND/OR IL-6 ≥ 1000 pg/mL AND/OR Ferritin ≥ 1000 ng/mL).
- Written informed, retrospective or prospective consent.
Who cannot join
- Patients under 18 years of age and over 80.
- Unlikely to survive for 24 hours (Moribund).
- Pregnancy.
- SOFA-2 score ≥ 16 at ICU admission.
- Source control is uncertain.
- Thrombocytopenia (<20,000/µL).
Show all 9Show fewer
- Criteria of standard guideline-based medical treatment not exhausted.
- End-stage organ failure (chronic renal failure (estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2), chronic liver failure (MELD Score >30, ChildPugh score class C.), chronic heart failure (New York Heart Association class IV.); severe chronic pulmonary disease (chronic obstructive pulmonary disease: GOLD D)).
- Expected need to disconnect CytoSorb therapy for more than 2 hours (e.g., surgery, CT transfer).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site
Semmelweis University, Department of Anaesthesiology and Intensive Therapy (Intenzív Terápiás Klinika).
Budapest, 1082
Zsolt Molnár, Prof. Dr., +36-1-459-1500, molnar.zsolt1@semmelweis.hu
About this study
Official title: Effects of Hemoadsorption on Vascular Integrity in Septic Shock (ADSORP-VIP Trial): Protocol of a Prospective, Randomised, Controlled Trial
This study aims to investigate the effects of adjunctive CytoSorb hemoadsorption therapy versus standard medical treatment on endothelial dysfunction in patients with refractory septic shock. The investigators hypothesize that hemoadsorption mitigates endothelial and glycocalyx injury by removing inflammatory mediators and other injurious circulating molecules, promoting hemodynamic stabilization.
Read the detailed description
This is a prospective, randomised, controlled, open-label, monocentric, proof-of-concept trial. Patients will be randomly assigned in a 1:1 ratio to receive either standard medical therapy alone or standard therapy plus continuous CytoSorb hemoadsorption for 24 hours. Blood samples will be collected at baseline, 6, 12, 18, and 24 hours, and then daily for 5 days to analyze endothelial markers, microRNAs, and inflammatory parameters. An adaptive group sequential design allows for an interim unblinded sample size re-estimation after the first 30 evaluable patients.
- Conditions
- Septic Shock
- Being tested
- CytoSorb hemoadsorption, Standard Medical Therapy (SMT)
- Keywords
- sepsis, septic shock, hemoadsorption, CytoSorb, endothelial dysfunction, syndecan-1, vasoplegia
- Medical subject headings
- Shock, Septic, Sepsis, Vasoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb hemoadsorptionDevice
Target blood flow rate of 1.5 ml/kg/min, implemented either as a standalone extracorporeal treatment or integrated into a CRRT circuit (CVVHDF mode, preferably with regional citrate anticoagulation).
Standard Medical Therapy (SMT)Other
Standard Medical Therapy according to local protocols based on the current international 'Surviving Sepsis Campaign' guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Standard Medical Therapy (Group A) | Active comparator | Patients will receive standard medical therapy (SMT) according to local protocols based on international 'Surviving Sepsis Campaign' guidelines. Receives: Other: Standard Medical Therapy (SMT) |
| CytoSorb Therapy (Group B) | Experimental | Patients will receive standard medical therapy plus a fixed 24-hour continuous hemoadsorption treatment utilizing two sequential CytoSorb cartridges (exchanged at the 12-hour mark). Receives: Device: CytoSorb hemoadsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Syndecan-1 serum levels
Serum Syndecan-1, a marker of endothelial glycocalyx injury, will be measured in arterial blood samples. The outcome is the log-scale change from baseline to the T24 post-baseline Syndecan-1 value in ng/mL. If the T24 value is missing, the value will be considered missing. Negative values indicate a decrease from baseline. Syndecan-1 values will be analysed on the natural logarithmic scale due to expected right skew.
Measured: Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days (including pre- and postadsorbent samples in the CytoSorb group)
Secondary outcomes (24)
Change in Sequential Organ Failure Assessment (SOFA)-2 score
Sequential Organ Failure Assessment (SOFA)-2 is an organ dysfunction score used in critically ill patients. SOFA-2 includes 6 organ systems with total score ranging from 0 to 24 (higher scores indicate worse organ dysfunction). Change from baseline will be calculated at each post-baseline assessment and reported in score points.
Measured: Baseline (T0), 24 hours, and then daily up to 5 days.
Change from baseline in arterial blood concentrations of endothelial and glycocalyx-specific markers (Glypican-1, Heparan-sulfate, sICAM-1, sVCAM-1, soluble E-selectin, soluble P-selectin)
Arterial blood concentrations of glypican-1, heparan sulfate, soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), soluble E-selectin (sE-selectin/CD62E), and soluble P-selectin (sP-selectin) will be measured in ng/mL. For each biomarker, the change from baseline (T0) will be calculated at each post-baseline assessment. Results will be reported separately for each biomarker; no composite score will be calculated.
Measured: Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days.
Change from baseline in arterial blood concentrations of endothelial markers (MCP-1, VEGF)
Arterial blood concentrations of monocyte chemoattractant protein-1/C-C motif chemokine ligand 2 (MCP-1/CCL2) and vascular endothelial growth factor (VEGF) will be measured in pg/mL. For each biomarker, the change from baseline (T0) will be calculated at each post-baseline assessment. Results will be reported separately for each biomarker; no composite score will be calculated.
Measured: Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days.
Change from baseline in quantification cycle values of selected microRNAs associated with endothelial function, vascular homeostasis, and inflammation (miR-126, miR-92a, miR-155, miR-21, miR-23a)
Expression of miR-126, miR-92a, miR-155, miR-21, and miR-23a will be measured in arterial blood samples by quantitative reverse-transcription polymerase chain reaction and reported as quantification cycle (Cq) values. For each microRNA, change from baseline at each post-baseline time point will be calculated as the Cq value at that time point minus the corresponding Cq value at baseline (T0). Results will be analyzed and reported separately for each microRNA; no composite or aggregated microRNA score will be calculated. Hemolyzed samples will be excluded from the microRNA analyses.
Measured: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in arterial lactate levels
Arterial lactate concentration will be measured in arterial blood samples and reported in mmol/L. at each post-baseline time point will be calculated as the arterial lactate concentration at that time point minus the arterial lactate concentration at baseline (T0). Changes at each time point will be reported separately.
Measured: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in procalcitonin concentration
Procalcitonin (PCT) concentration will be measured in arterial blood samples and reported in ng/mL. For each participant, change from baseline at each post-baseline time point will be calculated as the PCT concentration at that time point minus the PCT concentration at baseline (T0). Changes at each time point will be reported separately.
Measured: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in C-reactive protein concentration
C-reactive protein (CRP) concentration will be measured in arterial blood samples and reported in mg/L. For each participant, change from baseline at each post-baseline time point will be calculated as the CRP concentration at that time point minus the CRP concentration at baseline (T0). Changes at each time point will be reported separately.
Measured: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in white blood cell count
White blood cell count (WBC) will be measured in arterial blood samples and reported in G/L. For each participant, change from baseline at each post-baseline time point will be calculated as the WBC count at that time point minus the WBC count at baseline (T0). Changes at each time point will be reported separately.
Measured: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in ferritin concentration
Ferritin concentration will be measured in arterial blood samples and reported in ng/mL. For each participant, change from baseline at each post-baseline time point will be calculated as the ferritin concentration at that time point minus the ferritin concentration at baseline (T0). Changes at each time point will be reported separately.
Measured: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in tumor necrosis factor alpha concentration
Tumor necrosis factor alpha (TNF-α) concentration will be measured in arterial blood samples and reported in pg/mL. For each participant, change from baseline at each post-baseline time point will be calculated as the TNF-α concentration at that time point minus the TNF-α concentration at baseline (T0). Changes at each time point will be reported separately.
Measured: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in interleukin-1 beta concentration
Interleukin-1 beta (IL-1β) concentration will be measured in arterial blood samples and reported in pg/mL. For each participant, change from baseline at each post-baseline time point will be calculated as the IL-1β concentration at that time point minus the IL-1β concentration at baseline (T0). Changes at each time point will be reported separately.
Measured: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in interleukin-8 concentration
Interleukin-8 (IL-8) concentration will be measured in arterial blood samples and reported in pg/mL. For each participant, change from baseline at each post-baseline time point will be calculated as the IL-8 concentration at that time point minus the IL-8 concentration at baseline (T0). Changes at each time point will be reported separately.
Measured: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in extravascular Lung Water Index (EVLWI)
Extravascular Lung Water Index willl be measured using invasive hemodynamic monitoring and reported in ml/kg. Change from baseline at each post-baseline time point will be calculated as the EVLWI at that time point minus the EVLWI at baseline
Measured: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in Vasoactive-Inotropic Score (VIS)
The Vasoactive-Inotropic Score (VIS) quantifies the amount of cardiovascular support a patient receives through vasoactive and inotropic medications. The VIS is calculated as: VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10 × vasopressin (U/kg/min) at each time point. Higher score indicates worse outcome. VIS at each post-baseline time point will be calculated as the VIS at that time point minus the VIS at baseline (T0). Changes at each time point will be reported separately.
Measured: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Daily fluid balance through Day 28
Daily fluid balance will be calculated for each 24-hour period as total fluid intake minus total fluid output. Negative values indicate that fluid output exceeded fluid intake during the corresponding 24-hour period. Daily fluid balance will be reported in mL at each assessment day.
Measured: From T0 through Day 28, assessed every 24 hours
Time to first negative daily fluid balance
Time to first negative daily fluid balance will be calculated as the time from T0 to the end of the first 24-hour assessment period during which total fluid output exceeds total fluid intake, corresponding to a daily fluid balance of less than zero. Time will be reported in days. Participants who do not achieve a negative daily fluid balance by Day 28 will be censored at Day 28.
Measured: From T0 through Day 28
Cumulative fluid balance through Day 28
Cumulative fluid balance will be calculated as the sum of fluid intake minus fluid output from T0 through each assessment time point. Negative values indicate that cumulative fluid output exceeded cumulative fluid intake since T0. Cumulative fluid balance will be reported in mL at each assessment day.
Measured: From T0 through Day 28, assessed every 24 hours
Time to first negative cumulative fluid balance
Time to first negative cumulative fluid balance will be calculated as the time from T0 to the first assessment at which cumulative fluid output since T0 exceeds cumulative fluid intake since T0, corresponding to a cumulative fluid balance of less than zero. Time will be reported in days. Participants who do not achieve a negative cumulative fluid balance by Day 28 will be censored at Day 28.
Measured: From T0 through Day 28
Vasopressor-free days through Day 28
Vasopressor-free days will be calculated as the number of days from Day 1 through Day 28 during which the participant is alive and free from vasopressor treatment. A day will be counted as vasopressor-free only when no vasopressor is administered during that day. The possible range is 0 to 28 days, with higher values indicating more days alive without vasopressor support.
Measured: Day 1 through Day 28
Mechanical ventilation-free days through Day 28
Mechanical ventilation-free days will be calculated as the number of days from Day 1 through Day 28 during which the participant is alive and free from mechanical ventilation. A day will be counted as ventilation-free only when no mechanical ventilation is provided during that day. The possible range is 0 to 28 days, with higher values indicating more days alive without mechanical ventilatory support.
Measured: Day 1 through Day 28
Continuous renal replacement therapy-free days through Day 28
Continuous renal replacement therapy (CRRT)-free days will be calculated as the number of days from Day 1 through Day 28 during which the participant is alive and free from CRRT. A day will be counted as CRRT-free only when no CRRT is administered during that day. The possible range is 0 to 28 days, with higher values indicating more days alive without CRRT.
Measured: Day 1 through Day 28
Intensive Care Unit length of stay through Day 28
Intensive Care Unit (ICU) length of stay will be calculated as the elapsed time in days from ICU admission to ICU discharge or death in the ICU, whichever occurs first. Participants who remain in the ICU on Day 28 will be censored at Day 28.
Measured: From ICU admission through ICU discharge, death in the ICU, or Day 28, whichever occurs first
Survival rates (ICU survival, Hospital survival, and 28-day survival)
ICU survival, hospital survival, and 28-day survival will be recorded separately as alive/deceased status at ICU discharge, hospital discharge, and Day 28 after randomization. Results will be reported as proportions of participants surviving at each time point.
Measured: Up to 28 days.
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse events, serious adverse events, and device deficiencies will be recorded from baseline through Day 28. Events will be summarized by incidence, event type, severity, relationship to the study device or procedure, outcome, and seriousness.
Measured: From baseline up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
- Responsible party
- Sponsor
- Investigators
- Zsolt Molnár, Prof. Dr., Principal investigator, Department of Anaesthesiology and Intensive Therapy, Semmelweis University, Budapest, HungaryPéter Hegyi, Prof. Dr., Principal investigator, Centre for Translational Medicine, Semmelweis University, Budapest, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711197
- Sponsor's protocol ID
- ADSORP-VIP
- Other IDs
- 1158, NNGYK/26060-6/2026
- Acronym
- ADSORP-VIP
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hemoadsorption on Vascular Integrity in Septic Shock (ADSORP-VIP Trial): Protocol of a Prospective, Randomised, Controlled Trial
- ClinicalTrials.gov ID
- NCT07711197
- Acronym / sponsor ID
- ADSORP-VIP / ADSORP-VIP
- Conditions
- Septic Shock
- Keywords
- sepsis, septic shock, hemoadsorption, CytoSorb, endothelial dysfunction, syndecan-1, vasoplegia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 17 Jul 2026 (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 study aims to investigate the effects of adjunctive CytoSorb hemoadsorption therapy versus standard medical treatment on endothelial dysfunction in patients with refractory septic shock. The investigators hypothesize that hemoadsorption mitigates endothelial and glycocalyx injury by removing inflammatory mediators and other injurious circulating molecules, promoting hemodynamic stabilization.
Detailed description
This is a prospective, randomised, controlled, open-label, monocentric, proof-of-concept trial. Patients will be randomly assigned in a 1:1 ratio to receive either standard medical therapy alone or standard therapy plus continuous CytoSorb hemoadsorption for 24 hours. Blood samples will be collected at baseline, 6, 12, 18, and 24 hours, and then daily for 5 days to analyze endothelial markers, microRNAs, and inflammatory parameters. An adaptive group sequential design allows for an interim unblinded sample size re-estimation after the first 30 evaluable patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Medical Therapy (Group A) | Active comparator | Other: Standard Medical Therapy (SMT)Patients will receive standard medical therapy (SMT) according to local protocols based on international 'Surviving Sepsis Campaign' guidelines. |
| CytoSorb Therapy (Group B) | Experimental | Device: CytoSorb hemoadsorptionPatients will receive standard medical therapy plus a fixed 24-hour continuous hemoadsorption treatment utilizing two sequential CytoSorb cartridges (exchanged at the 12-hour mark). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Septic shock as defined by Sepsis-3 criteria.
- Serum lactate levels >2 and <8 mmol/L at screening.
- Fluid unresponsiveness: Objectively confirmed via dynamic tests or fluid challenges following initial resuscitation.
- Vasopressor Dose Threshold: Norepinephrine base equivalent (NEE) dose > 0.5 µg/kg/min.
- Systemic corticosteroid treatment on board for at least 30 minutes.
Key exclusion criteria (9 listed)
- Patients under 18 years of age and over 80.
- Unlikely to survive for 24 hours (Moribund).
- Pregnancy.
- SOFA-2 score ≥ 16 at ICU admission.
- Source control is uncertain.
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 |
|---|---|---|
| CytoSorb hemoadsorptionTarget blood flow rate of 1.5 ml/kg/min, implemented either as a standalone extracorporeal treatment or integrated into a CRRT circuit (CVVHDF mode, preferably with regional citrate anticoagulation). | Device | CytoSorb Therapy (Group B) |
| Standard Medical Therapy (SMT)Standard Medical Therapy according to local protocols based on the current international 'Surviving Sepsis Campaign' guidelines. | Other | Standard Medical Therapy (Group A) |
Primary outcome
Changes in Syndecan-1 serum levels
Time frame: Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days (including pre- and postadsorbent samples in the CytoSorb group)
Serum Syndecan-1, a marker of endothelial glycocalyx injury, will be measured in arterial blood samples. The outcome is the log-scale change from baseline to the T24 post-baseline Syndecan-1 value in ng/mL. If the T24 value is missing, the value will be considered missing. Negative values indicate a decrease from baseline. Syndecan-1 values will be analysed on the natural logarithmic scale due to expected right skew.
24 secondary outcomes
Change in Sequential Organ Failure Assessment (SOFA)-2 score
Time frame: Baseline (T0), 24 hours, and then daily up to 5 days.
Change from baseline in arterial blood concentrations of endothelial and glycocalyx-specific markers (Glypican-1, Heparan-sulfate, sICAM-1, sVCAM-1, soluble E-selectin, soluble P-selectin)
Time frame: Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days.
Change from baseline in arterial blood concentrations of endothelial markers (MCP-1, VEGF)
Time frame: Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days.
Change from baseline in quantification cycle values of selected microRNAs associated with endothelial function, vascular homeostasis, and inflammation (miR-126, miR-92a, miR-155, miR-21, miR-23a)
Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in arterial lactate levels
Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in procalcitonin concentration
Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in C-reactive protein concentration
Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in white blood cell count
Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in ferritin concentration
Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in tumor necrosis factor alpha concentration
Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in interleukin-1 beta concentration
Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in interleukin-8 concentration
Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in extravascular Lung Water Index (EVLWI)
Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Change from baseline in Vasoactive-Inotropic Score (VIS)
Time frame: Baseline (T0) and 6, 12, 18, 24, 48, 72, 96, and 120 hours after T0
Daily fluid balance through Day 28
Time frame: From T0 through Day 28, assessed every 24 hours
Time to first negative daily fluid balance
Time frame: From T0 through Day 28
Cumulative fluid balance through Day 28
Time frame: From T0 through Day 28, assessed every 24 hours
Time to first negative cumulative fluid balance
Time frame: From T0 through Day 28
Vasopressor-free days through Day 28
Time frame: Day 1 through Day 28
Mechanical ventilation-free days through Day 28
Time frame: Day 1 through Day 28
Continuous renal replacement therapy-free days through Day 28
Time frame: Day 1 through Day 28
Intensive Care Unit length of stay through Day 28
Time frame: From ICU admission through ICU discharge, death in the ICU, or Day 28, whichever occurs first
Survival rates (ICU survival, Hospital survival, and 28-day survival)
Time frame: Up to 28 days.
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From baseline up to 28 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
Zsolt Molnár, Prof. Dr. principal investigator
Department of Anaesthesiology and Intensive Therapy, Semmelweis University, Budapest, Hungary
Péter Hegyi, Prof. Dr. principal investigator
Centre for Translational Medicine, Semmelweis University, Budapest, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytoSorb hemoadsorption and Standard Medical Therapy (SMT) in people with Septic Shock, run by Semmelweis University at 1 site in Hungary.
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 11 inclusion and 9 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: opening soon, as of the sponsor's last update on 17 Jul 2026. 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 Hungary. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamás Tóth, Dr. (+36305399474, tomesz9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Syndecan-1 serum levels (time frame: Baseline (T0), 6, 12, 18, and 24 hours, and then daily up to 5 days (including pre- and postadsorbent samples in the CytoSorb group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2026.