An interventional study of hemoperfusion with polymyxin B in Multiple Organ Dysfunction With Severe Endotoxemia, sponsored by Petrovsky National Research Centre of Surgery. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Petrovsky National Research Centre of Surgery · Not applicable, Interventional, and Prevention
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.
PMX versus SS (polymyxin B versus septic shock) is a single-center, historic, randomized clinical trial to investigate the safety and efficacy of polymyxin B columns (PMX 20R, Toray) in adult patients with severe endotoxemia for the prevention and correction of septic shock after cardiac surgery. All patients must sign an informed consent prior to surgery. The study group will be represented by patients with severe multiple organ dysfunction (SOFA ≥5 points, PCT> 2 ng / ml; CRP> 150 ng / ml, vasopressor use, intestinal paresis and / or positive blood culture data) and endotoxin activity level on the test EAA is higher than 0.6. Patients by outcome will be divided into 2 groups according to the EAA test values: values from 0.6 to 0.89 (group A) and 0.9 and above (group B).
Due to the presence of renal failure in such patients, hemoperfusion will be performed in combination with the oXiris (Baxter) kit on the Prismaflex (Baxter) apparatus (PMX20R - 12 hours; oXiris - 72 hours). The effectiveness of PMX will be assessed based on the decrease in the EAA value below 0.6 12 hours after the end of the hemoperfusion session. If EAA2 is greater than 0.6 PMX will reconnect.
The safety of hemoperfusion will be assessed based on the presence of side effects (progression of signs of hemodynamic impairment) during the procedure.
The control group will consist of 10 patients (historical randomization without endotoxemia assessment) with septic shock with multiple organ dysfunction (SOFA ≥5, use of vasopressors) using the Oxyris universal renal replacement therapy kit for 72 hours. The comparison group will be formed by the matching method.
Additionally, the following will be assessed: the length of stay in the intensive care unit, mortality on the 14th and 28th days after the operation.
It is also planned to assess the dynamics of changes in the immunological status (cellular and humoral immunity) and microbiota metabolism (the level of aromatic microbial metabolites) during hemoperfusion.
81 studies on the registry are indexed under Endotoxemia; 7 are open to participants now.
This study's planned enrollment of 20 is below the median of 31 across 70 interventional studies indexed under Endotoxemia.
Browse Endotoxemia studies →Petrovsky National Research Centre of Surgery is the lead sponsor of 18 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
hemoperfusion procedure with polymyxin B will be performed for 12 hours
Device: hemoperfusion with polymyxin B
without hemoperfusion with polymyxin B
polymyxin B is covalently immobilized on polystyrene strands, selectively removes endotoxin and at the same time there is no leaching of the ligand, immobilization is carried out by electrostatic interaction and Vanderwals force
Also known as: PMX 20 R
endotoxin activity level
frequency of cases of decrease in EAA below 0.6
Time frame: 12 hours after the end of the procedure
vasopressor
frequency of discontinuation of vasopressor infusion
Time frame: 6 hours after the start of the procedure
mortality
frequency
Time frame: 14 and 28 day
SOFA
dynamics on the SOFA scale
Time frame: 24 hours after the end of the procedure
IL6/IL10
ratio
Time frame: 12, 24 hours after the end of the procedure
adverse events
frequency
Time frame: during the procedure
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Petrovsky National Research Centre of Surgery