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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPetrovsky National Research Centre of Surgery

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

SOFA +2 points in comparison with the previous assessment; РСТ more than 2 ng / ml; CRP more than 150 ng / ml; norepinephrine infusion; intestinal paresis; positive data of blood culture; ЕАА more than 0,6

Disqualifiers

bleeding; heparin-induced thrombocytopenia

Trial design

Design model

Parallel

Treatments tested in this trial

  • hemoperfusion with polymyxin B

    Device

    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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: cardiac surgery patients with multiple organ dysfunctionExperimental treatment 1 intervention
Group B: cardiac surgery patientsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

endotoxin activity level

frequency of cases of decrease in EAA below 0.6

Time frame
12 hours after the end of the procedure
2

vasopressor

frequency of discontinuation of vasopressor infusion

Time frame
6 hours after the start of the procedure

Secondary outcomes

1

mortality

frequency

Time frame
14 and 28 day
2

SOFA

dynamics on the SOFA scale

Time frame
24 hours after the end of the procedure
3

IL6/IL10

ratio

Time frame
12, 24 hours after the end of the procedure

Other outcomes

1

adverse events

frequency

Time frame
during the procedure

Sponsors and contacts

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