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

NCT06404424 | Completed

• 1 other identifier: efferon-2022-08
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sepsis; Septic shock; lipopolysaccharide sorption; cytokines apsorbtion; extracorporeal therapy

Outcome Measures

Primary Outcomes (1)

• Shock - Free Days

  All days of life, without vasopressor or inotropic support. A patient is given a value of 0 if they die before day 7 or are still remains in shock at day 7.

  0-7 days

Secondary Outcomes (4)

• ICU - Free Days

  0-60 days

• Mechanical ventilation - Free Days

  0-60 days

• Change SOFA score

  0-48 hours

• Change oxygenation index

  0-48 hours

Study Arms (3)

Baseline therapy

Patients of group one received standard treatment according to Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021, without the use of blood purification methods.

Baseline therapy + High-volume plasma exchange (HVPE) + Efferon CT hemoperfusion

Patients of second group received standart treatment, like first group and also high volume plasma exschange procedure and hemoperfusion procedure using Efferon CT device.

Device: Efferon CT

Baseline therapy + High-volume plasma exchange (HVPE) + Efferon LPS hemoperfusion

Patients of third group received standart treatment, like first group and also high volume plasma exschange procedure and hemoperfusion procedure using Efferon LPS device.

Device: Efferon LPS

Interventions

Efferon LPS DEVICE

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

Baseline therapy + High-volume plasma exchange (HVPE) + Efferon LPS hemoperfusion

Efferon CT DEVICE

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

Baseline therapy + High-volume plasma exchange (HVPE) + Efferon CT hemoperfusion

Eligibility Criteria

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

Study Population

Patients over 18 years old, with clinical signs of septic shock (SEPSIS-3) who were admitted to the intensive care unit (ICU)

You may qualify if:

• Age over 18 years
• Sepsis (SEPSIS-3)
• No more than 24 hours from the onset of septic shock.
• Septic shock, defined as hypotension in sepsis:
• Persisting after infusion therapy in a volume of 30 ml/kg
• Requiring sympathomimetic therapy with one or more of the listed drugs with the indicated doses: norepinephrine - more than 0,05 mcg/kg/min, dopamine - more than 10 mcg/kg/min, adrenaline - more than 0,05 mcg/kg/min,

You may not qualify if:

• Inability to achieve and maintain mean arterial pressure more than 65 mm Hg
• History of transfusion reactions, TRALI
• Allergy to heparin, history of HIT
• Uncontrolled bleeding or a high risk of its occurrence
• The presence of cardiovascular events during the last 2 months: AMI, stroke, pulmonary embolism
• Severe congestive CHF
• Terminal CKD, PGD
• HIV infection
• Continuous immunosuppressive therapy
• Severe granulocytopenia (WBC less than 500 cells/mm3)

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (1)

City clinical hospital named after S. S. Yudin, Moscow City Health Department

Moscow, Russia

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Nikolai Krotenko, PhD, MD

  City clinical hospital named after S. S. Yudin, Moscow City Health Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Locations

RU (1)