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Efficacy and Safety of Hemoperfusion With Polymyxin B in Septic Shock Associated With Severe Endotoxemia in Cardiac Surgery Patients (РМХ vs SS)

Study acronym: РМХ vs SS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 25, 2024 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Aug 31, 2024 to Aug 31, 2025
    • Study completion date: Dec 2024 to Dec 2025
    v5
  2. Notable Primary completion date: Aug 31, 2023 to Aug 31, 2024
    • Study completion date: Dec 2023 to Dec 2024
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: May 2022 to Aug 31, 2023
    • Study completion date: Dec 2022 to Dec 2023
    • Site details revised
    v3
  4. Notable Start date: Jul 2021 to Nov 1, 2021
    • Primary completion date: Dec 2021 to May 2022
    • Study completion date: Feb 2022 to Dec 2022
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sepsis is a state of multiple organ dysfunction caused by a generalized immune-inflammatory response of the body to an infectious agent, with pronounced heterogeneity and interchangeability of clinical and laboratory manifestations. Violation of autoregulation and multiple organ dysfunctions in case of not timely started and / or ineffective therapy lead to the development of multiple organ failure and thanatogenesis in 40-90% of cases. At the moment, there is no standardized approach to the treatment of the entire pool of sepsis patients. Pharmacological effects on receptors for interleukins and endotoxin, antibiotic therapy and immunoprotection do not allow taking the process under complete control. The pathogenesis and clinical diversity of manifestations dictates the need for a personalized approach based on identifying a group of patients with homogeneous characteristics and the course of the process, where one or another technique would have the greatest benefit. The choice of tactics for extracorporeal therapy should be based on early support of organ function and consistent elimination of high concentrations of trigger compounds (endotoxin, other metabolic products of microorganisms and products of cytolysis of a macroorganism), as well as aimed at minimizing the loss of proteins and immune complexes. The aim of this clinical study was to assess the efficacy and safety of the selective adsorption of endotoxin in patients with severe multiple organ dysfunction after complicated cardiac surgery.
Trial Details
NCT Number NCT04920565
Lead Sponsor Petrovsky National Research Centre of Surgery
Conditions
(from sponsor)
Multiple Organ Dysfunction With Severe Endotoxemia
Related terms Endotoxemia
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov