Effect of Extracorporeal Adsorption of Plasma Neutrophil Extracellular Traps (NET) in Sepsis

NCT ID: NCT04749238

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-26
• Study Completion Date: 2021-10-24

Brief Summary

This open non-randomized controlled single center study investigates to what extent the removal of circulating Neutrophil Extracellular Traps (NETs) from blood by NucleoCapture device has a positive effect on the treatment of patients with sepsis and sepsis-associated AKI (SA-AKI).

Detailed Description

The term "sepsis" refers to a clinical syndrome in which a dysregulation of the host's inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. Sepsis and septic shock are major causes of death in intensive care units worldwide. Sepsis remains the most important cause of AKI in the intensive care unit (ICU) with 15%-20% of patients with sepsis-associated AKI (SA-AKI) prescribed RRT . In addition to association with short term mortality, AKI is also linked to the later development of CKD, ESRD, and long-term increased risk of death

NETosis is a unique form of neutrophil cell death that is characterized by the release of neutrophil extracellular traps (NETs) composed of DNA web-like structures decorated with highly cytotoxic protein components. Release of NETs leads to bystander tissue damage (including the kidneys) and drives a fatal course of disease in sepsis patients.

The plasmapheresis is a medical procedure, where pathogenic components are being removed from the blood by adsorbers outside the body in an extracorporeal circulation. For removal of the pathogenic substances the plasma is separated from the blood to pass the adsorber. The purified plasma is merged with the solid blood components thereafter and returned to the patient. The NucleoCapture device provide highly selective removal of neutrophil extracellular traps from human blood during plasmapheresis procedure.

Conditions

Sepsis; Sepsis-associated AKI

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with NucleoCapture device

Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm.

Group Type: EXPERIMENTAL

NucleoCapture device

Intervention Type: DEVICE

Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm

Interventions

NucleoCapture device

Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm

Intervention Type: DEVICE

Other Intervention Names

NucleoCapture selective DNA adsorber

Eligibility Criteria

Inclusion Criteria

• Male or female ≥ 18 and ≤ 75 years of age.
• Meet the clinical criteria of sepsis according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))
• Written informed consent

Exclusion Criteria

• A terminal state
• Active bleeding or uncontrolled acute massive bleeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santersus AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

North-Western Regional Scientific and Clinical Center named after L.G. Sokolov

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

Nucleo 514/2020

Identifier Type: -

Identifier Source: org_study_id