Combined Hemoperfusion and Therapeutic Plasma Exchange for Treatment of Patients With Septic Shock

Summary

Sepsis is a critical burden for a healthcare. From 2000 to 2020, the number of publications and clinical studies on the topic of Sepsis and septic shock on the National Library of Medicine resource The National Center for Biotechnology Information has tripled. Sepsis is a life-threatening condition that causes significant pathophysiological changes in the body. Currently, sepsis is understood as organ dysfunction caused by a dysregulatory response of the macroorganism to infection. A special role in this process belongs to the innate and adaptive immune response.

Despite the trend towards improving survival rates, mortality in sepsis remains high - about 25%, reaching 60% with the development of septic shock.

Extracorporeal therapy, as an adjuvant method of treatment, has been used for more than 30 years, but conducting large randomized studies confirming its effectiveness is associated with a complex of problems, including the extreme heterogeneity of the population of patients with sepsis and septic shock, different etiologies and complex pathogenesis, non-identical pathophysiological pathways of the dominant organ dysfunction in specific time period and degree of its severity.

Goal of the study is to evaluate safety and efficiency of combined hemoperfusion and therapeutic plasma exchange in adult patients with septic shock.

Conditions

• Sepsis
• Septic Shock

Interventions

DEVICE

Efferon LPS

Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity. This device is routinely used for extracorporeal therapy of sepsis to improve hemodynamic function and abrogate septic shock. Plasma exchange procedures will be carried out with a replacement volume of 2 plasma volumes with fresh frozen plasma and albumin solution. Each patient is scheduled to undergo two separate hemoperfusions lasting 8-10 hours within 48 hours. 60 minutes before the start of hemoperfusion, additional administration of antimicrobial drugs is performed, taking into account their elimination during plasma exchange and adsorption

DEVICE

Efferon CT

Efferon CT, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that adsorbs excessive cytokines via its intrinsic porosity. This device is routinely used for extracorporeal therapy of "cytokine storm" syndrome in the course of severe SARS-CoV-2. Plasma exchange procedures will be carried out with a replacement volume of 2 plasma volumes with fresh frozen plasma and albumin solution. Each patient is scheduled to undergo two separate hemoperfusions lasting 8-10 hours within 48 hours. 60 minutes before the start of hemoperfusion, additional administration of antimicrobial drugs is performed, taking into account their elimination during plasma exchange and adsorption

Sponsors & Collaborators

• Efferon JSC

  lead INDUSTRY

Principal Investigators

• Nikolai Krotenko, PhD, MD · City clinical hospital named after S. S. Yudin, Moscow City Health Department

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-01

Primary Completion

2023-12-01

Completion

2024-03-01

Countries

• Russia

Study Locations