RecruitingNot ApplicableNCT05044403

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.


Sponsor

Hospital Clinic of Barcelona

Enrollment

48 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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 Criteria9

  • 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.

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Interventions

PROCEDUREExtracorporeal support with haemoperfusion

Use of extracorporeal support with haemoperfusion

PROCEDUREConventional treatment

Conventional treatment


Locations(1)

Hospital General Universitario de Castellon

Castellon, Castellón, Spain

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NCT05044403


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