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

NCT04749238 | Completed

• 1 other identifier: Nucleo 514/2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Sepsis; Sepsis-associated AKI

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• All-cause mortality

  from [start of treatment] through 28 days after

• SOFA scores change

  from [start of treatment] through 28 days after

• qSOFA scores change

  from [start of treatment] through 28 days after

Other Outcomes (1)

• Blood level of neutrophil extracellular traps (NETs) change over time

  from [start of treatment] through 28 days after

Study Arms (1)

Treatment with NucleoCapture device

EXPERIMENTAL

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

Device: NucleoCapture device

Interventions

NucleoCapture device DEVICE

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

Also known as: NucleoCapture selective DNA adsorber

Treatment with NucleoCapture device

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Santersus AG: lead

Study Sites (1)

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

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 11, 2021
• Study Start: January 26, 2021
• Primary Completion: October 24, 2021
• Study Completion: October 24, 2021
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

RU (1)