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

NCT04920565 | Recruiting

• 1 other identifier: 21021939
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Organ Dysfunction With Severe Endotoxemia

Keywords

test EAA; endotoxemia; hemoperfusion with Polymyxin B; cardiac syrgery

Outcome Measures

Primary Outcomes (2)

• endotoxin activity level

  frequency of cases of decrease in EAA below 0.6

  12 hours after the end of the procedure

• vasopressor

  frequency of discontinuation of vasopressor infusion

  6 hours after the start of the procedure

Secondary Outcomes (3)

• mortality

  14 and 28 day

• SOFA

  24 hours after the end of the procedure

• IL6/IL10

  12, 24 hours after the end of the procedure

Other Outcomes (1)

• adverse events

  during the procedure

Study Arms (2)

cardiac surgery patients with multiple organ dysfunction

EXPERIMENTAL

hemoperfusion procedure with polymyxin B will be performed for 12 hours

Device: hemoperfusion with polymyxin B

cardiac surgery patients

NO INTERVENTION

without hemoperfusion with polymyxin B

Interventions

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

Also known as: PMX 20 R

cardiac surgery patients with multiple organ dysfunction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• bleeding; heparin-induced thrombocytopenia

Sponsors & Collaborators

• Petrovsky National Research Centre of Surgery: lead

Study Sites (1)

Petrovsky National Reasearch Centre of Surgery

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

Endotoxemia

Interventions

Hemoperfusion

Condition Hierarchy (Ancestors)

Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• MAXIM BABAEV, D.Sc.(medical)

  Petrovsky NRCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MAXIM BABAEV, D.Sc.(medical)

CONTACT

89160269066; maxbabaev@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Using the matching method, a control group of 10 patients (historical randomization without endotoxemia assessment) with multiple organ dysfunction (SOFA ≥5, use of vasopressors) will be formed using the Oxyris universal set for renal replacement therapy for 72 hours.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In 10 patients meeting three of the following criteria: SOFA ≥5 points, PCT\> 2 ng / ml; CRP\> 150 ng / ml, vasopressor use, intestinal paresis and / or positive blood culture data - as well as with an EAA level above 0.6, a hemoperfusion procedure with polymyxin B will be performed for 12 hours. \- with an initial EAA level of more than 0.9, 2 hemoperfusion procedures will be performed with a difference of 12 hours

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 10, 2021
• Study Start: November 1, 2021
• Primary Completion: August 31, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

RU (1)