Evaluation of the Efficacy and Safety of Extracorporeal Support With Hemoperfusion in Critical Patients With Multiorgan Dysfunction Syndrome by Septic Origin

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2022

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Conventional treatment
    • Patients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin.
  • Experimental: Extracorporeal support with haemoperfusion treatment
    • Patients receiving extracorporeal support with haemoperfusion for multiorganic dysfunction syndrome from septic origin.

Clinical Trial Outcome Measures

Primary Measures

  • Vasopressors dose
    • Time Frame: During hemoperfusion
    • Analyze the patient’s vasopressor dose during the hemoperfusion process
  • Vasopressors dose – Intensive Care Unit discharge
    • Time Frame: Prior Intensive Care Unit discharge
    • Analyze the patient’s vasopressor dose prior Intensive Care Unit discharge
  • Vasopressors dose – Hospital discharge
    • Time Frame: Prior Hospital discharge
    • Analyze the patient’s vasopressor dose prior Hospital discharge
  • Vasopressors dose – 90 days post-Intensive Care Unit discharge
    • Time Frame: 90 days post-Intensive Care Unit discharge
    • Analyze the patient’s vasopressor dose 90 days post-Intensive Care Unit discharge

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital Clinic of Barcelona
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Fernando Sánchez Morán, 964399914, fsanchez201x@cv.gva.es

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