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Recruiting NCT05044403

Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.

No phase Interventional Hemoperfusion Multiorgan Failure Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Extracorporeal support with haemoperfusion, Conventional treatment.
Who it may be relevant to
Registry conditions: Hemoperfusion, Multiorgan Failure, Sepsis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with septic multiorgan dysfunction syndrome.

Interventions

  • Procedure Extracorporeal support with haemoperfusion
    Use of extracorporeal support with haemoperfusion
  • Procedure Conventional treatment
    Conventional treatment

Primary outcome measures

  • IL-6 plasmatic concentration [Time frame: During hemoperfusion]
  • Adverse events [Time frame: During hemoperfusion]
  • Organ failure [Time frame: During hemoperfusion]
  • Vasopressors dose [Time frame: During hemoperfusion]
  • Mean arterial pressure [Time frame: During hemoperfusion]
  • Vasopressors dose [Time frame: During ICU stay]
  • Mechanical ventilation [Time frame: During ICU stay]
  • Renal replacement therapy [Time frame: During ICU stay]
  • ICU length of stay [Time frame: Post-Intensive Care Unit discharge]
  • ICU survival [Time frame: Post-Intensive Care Unit discharge]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Spain · 1 center
  • Hospital General Universitario de Castellon — Castellon

Identifiers

NCT: NCT05044403 · MUL-HEMO-2021-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗