Hemoperfusion for adults with sepsis and multiorgan failure.
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.
Run by Hospital Clinic of Barcelona · NCT05044403 · Data updated 2026-11-12
This trial will test whether adding extracorporeal hemoperfusion to standard care helps adults with severe sepsis and multiple organ dysfunction who are not responding to usual treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Hospital Clinic of Barcelona Academic / other |
| Locations | 1 site (Castellon, Castellón) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | March 1, 2024 |
| Study ends | December 20, 2025 |
| Registry record updated | June 10, 2025 |
| Trial ID | NCT05044403 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with abdominal-source sepsis controlled at the focus, refractory shock requiring norepinephrine >0.5 µg/kg/min, dysfunction of two or more organs with SOFA ≥9, lactate ≥2 mmol/L, PCT >10 ng/mL, CRP >100 mg/L, and IL-6 >2000 pg/mL are ideal candidates.
✕Probably not a fit
Patients under 18 or over 80, pregnant or breastfeeding, with terminal illness or life expectancy <48 hours, severe thrombocytopenia (<60,000/mm3), pancytopenia, severe coagulopathy, uncontrolled infectious focus, or already enrolled in another protocol are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Critically ill adults with septic shock and multiorgan dysfunction will receive extracorporeal hemoperfusion in addition to conventional supportive care, with outcomes compared to patients receiving conventional treatment alone. Eligible patients are those with abdominal-source sepsis with a controlled focus, high vasopressor requirements, elevated SOFA score, and marked inflammatory and metabolic markers (PCT, CRP, IL-6, lactate). The study will monitor safety (including bleeding and cytopenias) and clinical outcomes such as organ function and survival during the acute ICU admission. Procedures occur in participating Spanish hospitals with experienced intensive care and extracorporeal support teams.
Why it matters
Potential benefit: If successful, hemoperfusion could reduce organ dysfunction and improve survival in adults with refractory septic shock.
How similar studies have gone: Previous small trials and case series of hemoperfusion in sepsis have shown mixed and preliminary results, so the approach remains exploratory rather than definitively proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. * CRP\> 100 mg / L. * IL-6\> 2000 pg / ml. Exclusion Criteria: * 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. * Inclusion in another research protocol. * In case of re-entry during the study period, only the first admission will be included. * Use of another haemoperfusion device.
Where it's running
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Hospital General Universitario de Castellon
Castellon, Castellón, Spain Recruiting
Study contacts
- Principal investigator: Fernando Sanchez Moran — Hospital General Universitario de Castellon
- Study coordinator: Fernando Sánchez Morán
- Email: sanchez_fermor@gva.es
- Phone: 964399914
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.