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.
1 other identifier
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2021
CompletedFirst Posted
Study publicly available on registry
September 14, 2021
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2025
CompletedJune 10, 2025
June 1, 2025
1 year
August 3, 2021
June 4, 2025
Conditions
Outcome Measures
Primary Outcomes (12)
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
Study Arms (2)
Conventional treatment
ACTIVE COMPARATORPatients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin.
Extracorporeal support with haemoperfusion treatment
EXPERIMENTALPatients receiving extracorporeal support with haemoperfusion for multiorganic dysfunction syndrome from septic origin.
Interventions
Use of extracorporeal support with haemoperfusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- In case of re-entry during the study period, only the first admission will be included.
- Use of another haemoperfusion device.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Clinic of Barcelonalead
- Hospital General Universitario de Castellóncollaborator
- Hospital Universitario La Pazcollaborator
- Hospital de Granollerscollaborator
- Hospital General Universitario Santa Lucíacollaborator
Study Sites (1)
Hospital General Universitario de Castellon
Castellon, Castellón, 12004, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando Sanchez Moran
Hospital General Universitario de Castellon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2021
First Posted
September 14, 2021
Study Start
March 1, 2023
Primary Completion
March 1, 2024
Study Completion
December 20, 2025
Last Updated
June 10, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
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.