Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Hemoperfusion; Multiorgan Failure
• Intervention / Treatment: Procedure: Conventional treatment; Procedure: Extracorporeal support with haemoperfusion

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernando Sánchez Morán; Phone Number: 964399914; Email: sanchez_fermor@gva.es

Study Locations

• Spain
  • Castellón
    • Castelló de la Plana, Castellón, Spain, 12004
      • Recruiting
      • Hospital General Universitario de Castellon
      • Contact: Fernando Sanchez Moran; Email: sanchez_fermor@gva.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional treatment; Patients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin.	Procedure: Conventional treatment; Conventional treatment
Experimental: Extracorporeal support with haemoperfusion treatment; Patients receiving extracorporeal support with haemoperfusion for multiorganic dysfunction syndrome from septic origin.	Procedure: Extracorporeal support with haemoperfusion; Use of extracorporeal support with haemoperfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL-6 plasmatic concentration	Analyze the patient's variation of IL-6 plasmatic concentration during the hemoperfusion process	During hemoperfusion
Adverse events	Analyze the presence of adverse events during the hemoperfusion process	During hemoperfusion
Organ failure	Analyze the number and severity of failed organs during the hemoperfusion process	During hemoperfusion
Vasopressors dose	Analyze the patient's vasopressor dose variation during the hemoperfusion process	During hemoperfusion
Mean arterial pressure	Analyze the patient's variation of mean arterial pressure during hemoperfusion	During hemoperfusion
Vasopressors dose	Analyze the number of days on vasopressor support during ICU stay	During ICU stay
Mechanical ventilation	Analyze the number of days on mechanical ventilation during ICU stay	During ICU stay
Renal replacement therapy	Analyze the number of days on renal replacement therapy during ICU stay	During ICU stay
ICU length of stay	Analyze the patient's length of stay in ICU	Post-Intensive Care Unit discharge
ICU survival	Analyze the patient's survival in ICU	Post-Intensive Care Unit discharge
Hospital stay	Analyze the patient's length of stay post-Intensive Care Unit discharge	post-hospital discharge
Hospital survival	Analyze the patient's survival post-hospital discharge	Post-hospital discharge

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Hospital General Universitario Santa Lucia; Hospital Universitario La Paz; Hospital de Granollers; Hospital General Universitario de Castellón
• Investigators: Principal Investigator: Fernando Sanchez Moran, Hospital General Universitario de Castellon

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Multiple Organ Failure
• Other Study ID Numbers: MUL-HEMO-2021-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No