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

Safety and Efficacy Assessment of NucleoCapture Selective DNA Adsorber in Humans

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).

Study Overview

• Status: Completed
• Conditions: Sepsis; Sepsis-associated AKI
• Intervention / Treatment: Device: NucleoCapture device

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Saint- Petersburg, Russian Federation
    • North-Western Regional Scientific and Clinical Center named after L.G. Sokolov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with NucleoCapture device; Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm.	Device: NucleoCapture device; Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm; Other Names: NucleoCapture selective DNA adsorber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of acute kidney injury (AKI)	Incidence of acute kidney injury (AKI) in accordance with Kidney Disease Improving Global Outcomes (KDIGO) definitions for AKI	from [start of treatment] through 28 days after
Severity of acute kidney injury (AKI)	Severity of acute kidney injury (AKI) in accordance with KDIGO definitions for AKI	from [start of treatment] through 28 days after
Rate of AKI transition to the more severe stage (for patients with AKI at baseline).	Rate of worsening of acute kidney injury (AKI) in accordance with KDIGO AKI classification (Changing stages from 1 to 2, from 2 to 3).	from [start of treatment] through 28 days after
Serum creatinine change over time	Change of creatinine in serum over time for each patient and in average in group	from [start of treatment] through 28 days after
Serum urea change over time	Change of urea in serum over time for each patient and in average in group	from [start of treatment] through 28 days after
Urine output change	Change of urine output over time for each patient and in average in group	from [start of treatment] through 28 days after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Mortality for any reasons for each patient and in average in group	from [start of treatment] through 28 days after
SOFA scores change	Change in SOFA scores over time for each patient and in average in group	from [start of treatment] through 28 days after
qSOFA scores change	Change in qSOFA scores over time for each patient and in average in group	from [start of treatment] through 28 days after

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood level of neutrophil extracellular traps (NETs) change over time	Change of NETs in blood over time for each patient and in average in group	from [start of treatment] through 28 days after

Collaborators and Investigators

• Sponsor: Santersus AG

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Actual): October 24, 2021
• Study Completion (Actual): October 24, 2021

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: December 3, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: Nucleo 514/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No