HemoadsorptionHOPE-FULNCT07679555
Hemodynamic, Laboratory, and Clinical Outcomes of Hemoadsorption Therapy
An observational study of Hemoadsorption and Vasopressor Therapy, run by Pest County Flór Ferenc Hospital at 1 site in Hungary.
Trial summary
This single-center retrospective observational cohort study aims to evaluate the clinical, hemodynamic, and laboratory effects of adjunctive hemoadsorption therapy in critically ill adult patients treated in the Intensive Care Unit of Flór Ferenc Hospital, Hungary, between January 1, 2020, and May 31, 2026. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemoadsorption, Vasopressor Therapy
- What is being tested?
- Hemoadsorption
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2020to 30 Sep 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will be retrospective. Patients who received adjunctive hemoadsorption therapy at the Department of Anesthesiology and Intensive Care of Flór Ferenc Hospital between January 1, 2020, and May 31, 2026, will be included in the study.
Who may be able to join
- >18 years;
- CytoSorb or Efferon LPS hemoadsorption treatment,
- with available relevant pre- and post-treatment clinical and laboratory data
Who cannot join
- age under 18 years
- missing key demographic or outcome data;
- unknown treatment type or timing;
- data unavailable for legal or ethical reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gergely Bokrétás, MD contact
Hungary1 site, 1 recruiting
- Recruiting
Pest County Flór Ferenc Hospital, Dept. of Anaesthesiology and Intensive Therapy
Kistarcsa, Pest County, 2143
Zoltán Ruszkai, MD, PhD, 0036209151978, ruszkai.zoltan@florhosp.hu
Gergely Bokrétás, MD, bokretas.gergely@florhosp.hu
About this study
Official title: Hemodynamic, Laboratory, and Clinical Outcomes of Hemoadsorption theraPy: an obsErvational Study at Flór Ferenc Hospital Using Longitudinal Data (HOPE-FUL)
This single-center retrospective observational cohort study aims to evaluate the clinical, hemodynamic, and laboratory effects of adjunctive hemoadsorption therapy in critically ill adult patients treated in the Intensive Care Unit of Flór Ferenc Hospital, Hungary, between January 1, 2020, and May 31, 2026. Patients who received CytoSorb® or Efferon LPS® hemoadsorption therapy will be included.
The study will assess changes in vasopressor requirements, hemodynamic parameters, inflammatory biomarkers, liver function tests, tissue perfusion markers, and oxygenation following hemoadsorption treatment. Clinical outcomes, including intensive care unit length of stay, all-cause mortality occurring during the patient's stay in the intensive care unit (ICU mortality), and 28-day and 90-day mortality, will also be evaluated. Data will be collected retrospectively from anonymized medical records, and no study-related interventions will be performed.
Read the detailed description
Sepsis, septic shock, and other severe systemic inflammatory conditions remain among the leading causes of morbidity and mortality in critically ill patients. Dysregulated inflammatory host response is characterized by the excessive release of cytokines, endotoxins, and other inflammatory mediators, which contribute to endothelial injury, microcirculatory dysfunction, vasoplegia, tissue hypoperfusion, organ dysfunction, and multiple organ failure.
Hemoadsorption is an extracorporeal blood purification technique designed to remove circulating inflammatory mediators, toxins, drugs and other harmful molecules. Several hemoadsorption devices, including CytoSorb® and Efferon LPS®, have been increasingly used as adjunctive therapies in patients with septic shock and other hyperinflammatory conditions. Although their use has expanded substantially in daily clinical practice, evidence regarding their effectiveness remains heterogeneous or even controversial, that is why additional clinical data are needed to better define their role and impact on patient outcomes.
This single-center retrospective observational cohort study will evaluate the clinical, hemodynamic, and laboratory effects of adjunctive hemoadsorption therapy in adult patients treated in the Department of Anesthesiology and Intensive Therapy at Flór Ferenc Hospital, Kistarcsa, Hungary, between January 1, 2020, and May 31, 2026. Eligible patients are those who received CytoSorb® or Efferon LPS® hemoadsorption therapy as part of routine clinical care.
The primary objective is to assess the effect of hemoadsorption therapy on vasopressor requirements, measured by changes in the Vasoactive Inotropic Score (VIS). Secondary outcome measures include evaluation of changes in the Vasopressor Dependency Index (VDI), shock reversal time, inflammatory biomarkers (procalcitonin and C-reactive protein), liver function parameters (transaminases and bilirubin), tissue perfusion markers (arterial lactate concentration), and oxygenation indicated by the arterial oxygen partial pressure to inspired oxygen fraction ratio (PaO₂/FiO₂) ratio. Additional outcomes include changes in organ dysfunction severity scores, intensive care unit length of stay, all-cause mortality occurring during the patient's stay in the intensive care unit (ICU mortality), and 28-day and 90-day mortality.
Data will be collected retrospectively from anonymized electronic medical records, intensive care documentation systems, laboratory information systems, extracorporeal treatment records, and national electronic health records used to verify survival outcomes. No study-specific interventions, diagnostic procedures, or alterations in patient management will be performed. The study is designed to generate real-world evidence regarding the effectiveness of hemoadsorption therapy and to improve understanding of its impact on hemodynamic stabilization, inflammatory response, organ function, and survival in critically ill patients.
- Conditions
- Hemoadsorption, Vasopressor Therapy
- Being tested
- Hemoadsorption
- Keywords
- hemoadsorption, CytoSorb, Efferon LPS, Vasoactive Inotropic Score, Vasopressor Dependency Index, Shock reversal time, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoadsorptionProcedure or surgery
Patients included in this retrospective observational study received adjunctive hemoadsorption therapy as part of routine clinical care at the discretion of the treating intensive care physicians. Hemoadsorption was performed using either the CytoSorb® or Efferon LPS® hemoadsorption cartridge, according to the clinical indication and device availability.
Hemoadsorption was integrated into a continuous renal replacement therapy (CRRT) circuit. Treatment duration, number of hemoadsorption sessions, timing of therapy initiation, and concomitant intensive care interventions were determined by the treating physicians and were not influenced by the study protocol.
No study-specific interventions, additional diagnostic procedures, or protocol-mandated treatments were performed.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving hemoadsorption treatment | Critically ill patients who received hemoadsorption therapy using CytoSorb or Efferon LPS between January 1 2020 and May 31 2026 Receives: Procedure: Hemoadsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vasoactive Inotropic Score (VIS) from baseline to 24 hours after completion of hemoadsorption therapy
The primary endpoint is the change in vasopressor and inotropic support requirements, quantified using the Vasoactive Inotropic Score (VIS), from immediately before initiation of hemoadsorption therapy (baseline) to 24 hours after completion of treatment.
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)
Measured: Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy
Secondary outcomes (4)
Change in Vasopressor Dependency Index (VDI) from baseline to 24 hours after completion of hemoadsorption therapy
The secondary endpoint is the change in vasopressor dependency, quantified using the Vasopressor Dependency Index (VDI), from immediately before initiation of hemoadsorption therapy (baseline) to 24 hours after completion of treatment.
The VDI is a hemodynamic severity index that quantifies the relationship between vasopressor requirements and mean arterial pressure (MAP). Higher VDI values indicate greater hemodynamic instability and are associated with increased disease severity, a higher risk of mortality, and, in patients with septic shock, a greater likelihood of severe vasoplegia.
The VDI is calculated as:
VDI = (NEE / MAP) × 100
where:
NEE (Norepinephrine Equivalent dose) = norepinephrine (µg/kg/min) + epinephrine (µg/kg/min) + 0.01 × dopamine (µg/kg/min) + 0.06 × phenylephrine (µg/kg/min) + 2.5 × vasopressin (U/min) MAP = mean arterial pressure (mmHg)
Measured: Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy.
Shock Reversal Time (SRT)
Shock Reversal Time (SRT) is defined as the time from initiation of hemoadsorption therapy to sustained hemodynamic stabilization, according to predefined criteria.
Hemodynamic stabilization is considered achieved when all of the following criteria are met:
(1) vasopressor requirements have ceased or decreased to ≤10% of the maximum dose and are maintained for at least 3 consecutive hours, including norepinephrine and/or vasopressin; (2) for patients receiving multiple vasopressors, reduction of at least one vasopressor to ≤10% of its maximum dose is considered sufficient, provided that no increase in the dose of any other vasopressor is required; (3) Low-dose vasopressor support (≤10% of the maximum dose) may be continued if required to compensate for sedation or to maintain adequate organ perfusion; (4) in patients undergoing invasive hemodynamic monitoring, a cardiac index (CI) ≥2.5 L/min/m² is required; (5) arterial lactate ≤2 mmol/L; (6) ScvO₂ >70%; (7) dCO₂ < 7 mmHg
Measured: From initiation of hemoadsorption therapy until achievement of shock reversal, assessed during the first 24 hours after completion of hemoadsorption therapy.
Change in laboratory biomarkers from baseline to immediately after and 24 hours after completion of hemoadsorption therapy
Changes in laboratory biomarkers will be assessed from baseline (immediately before initiation of hemoadsorption therapy) to immediately after treatment and 24 hours after completion of therapy. The following biomarkers will be evaluated: (1) arterial lactate; (2) Procalcitonin (PCT); (3) C-reactive protein (CRP); (4) Aspartate aminotransferase (ASAT); (5) Alanine aminotransferase (ALAT); (6) Total bilirubin.
For each laboratory parameter, both absolute and relative changes will be calculated:
(1) Absolute change = post-treatment value - baseline value; (2) Relative change (%) = [(post-treatment value - baseline value) / baseline value] × 100
Measured: Baseline (immediately before hemoadsorption therapy), immediately after completion of hemoadsorption therapy, and 24 hours after completion of therapy.
Change in oxygenation (PaO₂/FiO₂ ratio) from baseline to immediately after and 24 hours after completion of hemoadsorption therapy
Changes in oxygenation will be assessed using the arterial oxygen partial pressure to inspired oxygen fraction ratio (PaO₂/FiO₂). Measurements will be obtained immediately before initiation of hemoadsorption therapy (baseline), immediately after completion of therapy, and 24 hours after completion of therapy.
For the PaO₂/FiO₂ ratio, both absolute and relative changes will be calculated: (1) Absolute change = post-treatment value - baseline value; (2) Relative change (%) = [(post-treatment value - baseline value) / baseline value] × 100
Measured: Baseline (immediately before hemoadsorption therapy), immediately after completion of hemoadsorption therapy, and 24 hours after completion of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jan 2020
- Primary completion31 May 2026
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoadsorptionStudies 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
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pest County Flór Ferenc Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zoltan Ruszkai, MD, PhD, Pest County Flór Ferenc Hospital
- Investigators
- Zoltán Ruszkai, MD, PhD, Study director, Pest County Flór Ferenc Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679555
- Sponsor's protocol ID
- 169-IK/2026
- Acronym
- HOPE-FUL
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable individual participant data will be collected. All patient-level data will be anonymized, and no IPD will be made available for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic, Laboratory, and Clinical Outcomes of Hemoadsorption theraPy: an obsErvational Study at Flór Ferenc Hospital Using Longitudinal Data (HOPE-FUL)
- ClinicalTrials.gov ID
- NCT07679555
- Acronym / sponsor ID
- HOPE-FUL / 169-IK/2026
- Conditions
- Hemoadsorption, Vasopressor Therapy
- Keywords
- hemoadsorption, CytoSorb, Efferon LPS, Vasoactive Inotropic Score, Vasopressor Dependency Index, Shock reversal time, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pest County Flór Ferenc HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 1 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 single-center retrospective observational cohort study aims to evaluate the clinical, hemodynamic, and laboratory effects of adjunctive hemoadsorption therapy in critically ill adult patients treated in the Intensive Care Unit of Flór Ferenc Hospital, Hungary, between January 1, 2020, and May 31, 2026. Patients who received CytoSorb® or Efferon LPS® hemoadsorption therapy will be included.
The study will assess changes in vasopressor requirements, hemodynamic parameters, inflammatory biomarkers, liver function tests, tissue perfusion markers, and oxygenation following hemoadsorption treatment. Clinical outcomes, including intensive care unit length of stay, all-cause mortality occurring during the patient's stay in the intensive care unit (ICU mortality), and 28-day and 90-day mortality, will also be evaluated. Data will be collected retrospectively from anonymized medical records, and no study-related interventions will be performed.
Detailed description
Sepsis, septic shock, and other severe systemic inflammatory conditions remain among the leading causes of morbidity and mortality in critically ill patients. Dysregulated inflammatory host response is characterized by the excessive release of cytokines, endotoxins, and other inflammatory mediators, which contribute to endothelial injury, microcirculatory dysfunction, vasoplegia, tissue hypoperfusion, organ dysfunction, and multiple organ failure.
Hemoadsorption is an extracorporeal blood purification technique designed to remove circulating inflammatory mediators, toxins, drugs and other harmful molecules. Several hemoadsorption devices, including CytoSorb® and Efferon LPS®, have been increasingly used as adjunctive therapies in patients with septic shock and other hyperinflammatory conditions. Although their use has expanded substantially in daily clinical practice, evidence regarding their effectiveness remains heterogeneous or even controversial, that is why additional clinical data are needed to better define their role and impact on patient outcomes.
This single-center retrospective observational cohort study will evaluate the clinical, hemodynamic, and laboratory effects of adjunctive hemoadsorption therapy in adult patients treated in the Department of Anesthesiology and Intensive Therapy at Flór Ferenc Hospital, Kistarcsa, Hungary, between January 1, 2020, and May 31, 2026. Eligible patients are those who received CytoSorb® or Efferon LPS® hemoadsorption therapy as part of routine clinical care.
The primary objective is to assess the effect of hemoadsorption therapy on vasopressor requirements, measured by changes in the Vasoactive Inotropic Score (VIS). Secondary outcome measures include evaluation of changes in the Vasopressor Dependency Index (VDI), shock reversal time, inflammatory biomarkers (procalcitonin and C-reactive protein), liver function parameters (transaminases and bilirubin), tissue perfusion markers (arterial lactate concentration), and oxygenation indicated by the arterial oxygen partial pressure to inspired oxygen fraction ratio (PaO₂/FiO₂) ratio. Additional outcomes include changes in organ dysfunction severity scores, intensive care unit length of stay, all-cause mortality occurring during the patient's stay in the intensive care unit (ICU mortality), and 28-day and 90-day mortality.
Data will be collected retrospectively from anonymized electronic medical records, intensive care documentation systems, laboratory information systems, extracorporeal treatment records, and national electronic health records used to verify survival outcomes. No study-specific interventions, diagnostic procedures, or alterations in patient management will be performed. The study is designed to generate real-world evidence regarding the effectiveness of hemoadsorption therapy and to improve understanding of its impact on hemodynamic stabilization, inflammatory response, organ function, and survival in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving hemoadsorption treatment | – | Procedure: HemoadsorptionCritically ill patients who received hemoadsorption therapy using CytoSorb or Efferon LPS between January 1 2020 and May 31 2026 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be retrospective. Patients who received adjunctive hemoadsorption therapy at the Department of Anesthesiology and Intensive Care of Flór Ferenc Hospital between January 1, 2020, and May 31, 2026, will be included in the study.
Key inclusion criteria (3 listed)
- >18 years;
- CytoSorb or Efferon LPS hemoadsorption treatment,
- with available relevant pre- and post-treatment clinical and laboratory data
Key exclusion criteria (4 listed)
- age under 18 years
- missing key demographic or outcome data;
- unknown treatment type or timing;
- data unavailable for legal or ethical reasons.
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 |
|---|---|---|
| HemoadsorptionPatients included in this retrospective observational study received adjunctive hemoadsorption therapy as part of routine clinical care at the discretion of the treating intensive care physicians. Hemoadsorption was performed using either the CytoSorb® or Efferon LPS® hemoadsorption cartridge, according to the clinical indication and device availability. Hemoadsorption was integrated into a continuous renal replacement therapy (CRRT) circuit. Treatment duration, number of hemoadsorption sessions, timing of therapy initiation, and concomitant intensive care interventions were determined by the treating physicians and were not influenced by the study protocol. No study-specific interventions, additional diagnostic procedures, or protocol-mandated treatments were performed. | Procedure or surgery | Patients receiving hemoadsorption treatment |
Primary outcome
Change in Vasoactive Inotropic Score (VIS) from baseline to 24 hours after completion of hemoadsorption therapy
Time frame: Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy
The primary endpoint is the change in vasopressor and inotropic support requirements, quantified using the Vasoactive Inotropic Score (VIS), from immediately before initiation of hemoadsorption therapy (baseline) to 24 hours after completion of treatment. 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)
4 secondary outcomes
Change in Vasopressor Dependency Index (VDI) from baseline to 24 hours after completion of hemoadsorption therapy
Time frame: Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy.
Shock Reversal Time (SRT)
Time frame: From initiation of hemoadsorption therapy until achievement of shock reversal, assessed during the first 24 hours after completion of hemoadsorption therapy.
Change in laboratory biomarkers from baseline to immediately after and 24 hours after completion of hemoadsorption therapy
Time frame: Baseline (immediately before hemoadsorption therapy), immediately after completion of hemoadsorption therapy, and 24 hours after completion of therapy.
Change in oxygenation (PaO₂/FiO₂ ratio) from baseline to immediately after and 24 hours after completion of hemoadsorption therapy
Time frame: Baseline (immediately before hemoadsorption therapy), immediately after completion of hemoadsorption therapy, and 24 hours after completion of therapy.
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 7 Jul 2026.
- Individual participant dataSharing planned: No. No identifiable individual participant data will be collected. All patient-level data will be anonymized, and no IPD will be made available for sharing.
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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.
Gergely Bokrétás, MD contact
Zoltán Ruszkai, MD, PhD study director
Pest County Flór Ferenc Hospital
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 Hemoadsorption and Vasopressor Therapy, run by Pest County Flór Ferenc Hospital 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 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 Zoltán Ruszkai, MD, PhD (0036209151978, ruszkai.zoltan@florhosp.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vasoactive Inotropic Score (VIS) from baseline to 24 hours after completion of hemoadsorption therapy (time frame: Baseline (immediately before hemoadsorption therapy) to 24 hours after completion of hemoadsorption therapy). 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 7 Jul 2026.