HemoperfusionNCT05044403
Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.
A study testing Extracorporeal support with haemoperfusion and Conventional treatment in people with Hemoperfusion and Multiorgan Failure, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with septic multiorgan dysfunction syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemoperfusion, Multiorgan Failure, Sepsis
- What is being tested?
- Extracorporeal support with haemoperfusion and Conventional treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 20 Dec 2025
- 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
- Patients with a sepsis diagnosis, according to the diagnostic criteria of the International Sepsis-3 Consensus Conference, and without response to the treatment of septic shock who meet the following conditions:
- Sepsis of abdominal origin with controlled infectious focus.
- Noradrenaline dose> 0.5 µg / kg / min to maintain adequate organ perfusion after optimization of fluid therapy.
- Dysfunction of two or more organs with SOFA ≥ 9 (5).
- Blood lactate ≥ 2 mmol / L.
- Procalcitonin (PCT)> 10 ng / mL.
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- CRP> 100 mg / L.
- IL-6> 2000 pg / ml.
- In case of re-entry during the study period, only the first admission will be included.
- Use of another haemoperfusion device.
Who cannot join
- Age under 18 years or over 80 years.
- Pregnancy or breastfeeding.
- Terminally ill patients or with a life expectancy of less than 48 hours.
- Thrombocytopenia <60,000 / mm3.
- Pancytopenia.
- Severe coagulopathy with high risk of bleeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario de Castellon
Castellon, Castellón, 12004
Fernando Sanchez Moran, sanchez_fermor@gva.es
About this study
Official title: Clinical Impact of Hemoperfusion With a Neutral Macroporous Resin Cartridge as Adjunctive Treatment in Septic Patients With Multiorgan Dysfunction Syndrome (MODS) Admitted to Intensive Care Units.
Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with septic multiorgan dysfunction syndrome.
- Conditions
- Hemoperfusion, Multiorgan Failure, Sepsis
- Being tested
- Extracorporeal support with haemoperfusion, Conventional treatment
- Medical subject headings
- Multiple Organ Failure, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal support with haemoperfusionProcedure or surgery
Use of extracorporeal support with haemoperfusion
Conventional treatmentProcedure or surgery
Conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Active comparator | Patients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin. Receives: Procedure: Conventional treatment |
| Extracorporeal support with haemoperfusion treatment | Experimental | Patients receiving extracorporeal support with haemoperfusion for multiorganic dysfunction syndrome from septic origin. Receives: Procedure: Extracorporeal support with haemoperfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6 plasmatic concentration
Analyze the patient's variation of IL-6 plasmatic concentration during the hemoperfusion process
Measured: During hemoperfusion
Adverse events
Analyze the presence of adverse events during the hemoperfusion process
Measured: During hemoperfusion
Organ failure
Analyze the number and severity of failed organs during the hemoperfusion process
Measured: During hemoperfusion
Vasopressors dose
Analyze the patient's vasopressor dose variation during the hemoperfusion process
Measured: During hemoperfusion
Mean arterial pressure
Analyze the patient's variation of mean arterial pressure during hemoperfusion
Measured: During hemoperfusion
Vasopressors dose
Analyze the number of days on vasopressor support during ICU stay
Measured: During ICU stay
Mechanical ventilation
Analyze the number of days on mechanical ventilation during ICU stay
Measured: During ICU stay
Renal replacement therapy
Analyze the number of days on renal replacement therapy during ICU stay
Measured: During ICU stay
ICU length of stay
Analyze the patient's length of stay in ICU
Measured: Post-Intensive Care Unit discharge
ICU survival
Analyze the patient's survival in ICU
Measured: Post-Intensive Care Unit discharge
Hospital stay
Analyze the patient's length of stay post-Intensive Care Unit discharge
Measured: post-hospital discharge
Hospital survival
Analyze the patient's survival post-hospital discharge
Measured: Post-hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Mar 2023
- Primary completion1 Mar 2024
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoperfusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario de Castellón, Hospital Universitario La Paz, Hospital de Granollers, Hospital General Universitario Santa Lucía
- Responsible party
- Sponsor
- Investigators
- Fernando Sanchez Moran, Principal investigator, Hospital General Universitario de Castellon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044403
- Sponsor's protocol ID
- MUL-HEMO-2021-1
- Status last verified
- Jun 2025
- First submitted
- 3 Aug 2021
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Background Abdominal sepsis remains a major challenge in critical care, often associated with high morbidity and mortality. Hemoadsorption therapy has been proposed as a strategy to modulate the systemic inflammatory response in septic patients. However, clinical evidence in the abdominal sepsis population is limited. Conclusions Haemoadsorption appears to be a feasible and safe intervention in patients with abdominal sepsis. Preliminary results suggest potential benefits in inflammatory modulation, organ function improvement, and mortality reduction. Larger, more robust clinical trials are required to confirm efficacy and clarify its impact on clinical outcomes. A more comprehensive and detailed analysis of the results will be provided upon completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Hemoperfusion With a Neutral Macroporous Resin Cartridge as Adjunctive Treatment in Septic Patients With Multiorgan Dysfunction Syndrome (MODS) Admitted to Intensive Care Units.
- ClinicalTrials.gov ID
- NCT05044403
- Acronym / sponsor ID
- MUL-HEMO-2021-1
- Conditions
- Hemoperfusion, Multiorgan Failure, Sepsis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Hospital General Universitario de Castellón, Hospital Universitario La Paz, Hospital de Granollers, Hospital General Universitario Santa Lucía
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 14 Sep 2021 (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.
Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with septic multiorgan dysfunction syndrome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Active comparator | Procedure: Conventional treatmentPatients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin. |
| Extracorporeal support with haemoperfusion treatment | Experimental | Procedure: Extracorporeal support with haemoperfusionPatients receiving extracorporeal support with haemoperfusion for multiorganic dysfunction syndrome from septic origin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with a sepsis diagnosis, according to the diagnostic criteria of the International Sepsis-3 Consensus Conference, and without response to the treatment of septic shock who meet the following conditions:
- Sepsis of abdominal origin with controlled infectious focus.
- Noradrenaline dose> 0.5 µg / kg / min to maintain adequate organ perfusion after optimization of fluid therapy.
- Dysfunction of two or more organs with SOFA ≥ 9 (5).
- Blood lactate ≥ 2 mmol / L.
Key exclusion criteria (6 listed)
- Age under 18 years or over 80 years.
- Pregnancy or breastfeeding.
- Terminally ill patients or with a life expectancy of less than 48 hours.
- Thrombocytopenia <60,000 / mm3.
- Pancytopenia.
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 |
|---|---|---|
| Extracorporeal support with haemoperfusionUse of extracorporeal support with haemoperfusion | Procedure or surgery | Extracorporeal support with haemoperfusion treatment |
| Conventional treatmentConventional treatment | Procedure or surgery | Conventional treatment |
Primary outcome
IL-6 plasmatic concentration
Time frame: During hemoperfusion
Analyze the patient's variation of IL-6 plasmatic concentration during the hemoperfusion process
Adverse events
Time frame: During hemoperfusion
Analyze the presence of adverse events during the hemoperfusion process
Organ failure
Time frame: During hemoperfusion
Analyze the number and severity of failed organs during the hemoperfusion process
Vasopressors dose
Time frame: During hemoperfusion
Analyze the patient's vasopressor dose variation during the hemoperfusion process
Mean arterial pressure
Time frame: During hemoperfusion
Analyze the patient's variation of mean arterial pressure during hemoperfusion
Vasopressors dose
Time frame: During ICU stay
Analyze the number of days on vasopressor support during ICU stay
Mechanical ventilation
Time frame: During ICU stay
Analyze the number of days on mechanical ventilation during ICU stay
Renal replacement therapy
Time frame: During ICU stay
Analyze the number of days on renal replacement therapy during ICU stay
ICU length of stay
Time frame: Post-Intensive Care Unit discharge
Analyze the patient's length of stay in ICU
ICU survival
Time frame: Post-Intensive Care Unit discharge
Analyze the patient's survival in ICU
Hospital stay
Time frame: post-hospital discharge
Analyze the patient's length of stay post-Intensive Care Unit discharge
Hospital survival
Time frame: Post-hospital discharge
Analyze the patient's survival post-hospital discharge
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 10 Jun 2025.
- Individual participant dataSharing planned: Yes. Background Abdominal sepsis remains a major challenge in critical care, often associated with high morbidity and mortality. Hemoadsorption therapy has been proposed as a strategy to modulate the systemic inflammatory response in septic patients. However, clinical evidence in the abdominal sepsis population is limited. Conclusions Haemoadsorption appears to be a feasible and safe intervention in patients with abdominal sepsis. Preliminary results suggest potential benefits in inflammatory modulation, organ function improvement, and mortality reduction. Larger, more robust clinical trials are required to confirm efficacy and clarify its impact on clinical outcomes. A more comprehensive and detailed analysis of the results will be provided upon completion of the study.
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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.
Fernando Sanchez Moran principal investigator
Hospital General Universitario de Castellon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal support with haemoperfusion and Conventional treatment in people with Hemoperfusion and Multiorgan Failure, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 10 inclusion and 6 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 10 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 Spain. 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 Fernando Sánchez Morán (964399914, sanchez_fermor@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 plasmatic concentration (time frame: During hemoperfusion). The study lists 12 primary outcomes in all. 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 10 Jun 2025.