Hemoperfusion for adults with sepsis and multiorgan failure.

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.

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Hospital Clinic of Barcelona (Academic / other)
• Locations: 1 site (Castellon, Castellón)
• Trial ID: NCT05044403 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Castellon, Castellón

• 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

Conditions Hemoperfusion; Multiorgan Failure; Sepsis