Skip to main content
OpenTrials
Completed

NCT Number: NCT04749238

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Saint Petersburg, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NucleoCapture device

Device

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

Other names: NucleoCapture selective DNA adsorber

Primary outcomes

  1. Incidence of acute kidney injury (AKI)

    Time frame: from [start of treatment] through 28 days after

    Incidence of acute kidney injury (AKI) in accordance with Kidney Disease Improving Global Outcomes (KDIGO) definitions for AKI

  2. Severity of acute kidney injury (AKI)

    Time frame: from [start of treatment] through 28 days after

    Severity of acute kidney injury (AKI) in accordance with KDIGO definitions for AKI

  3. Rate of AKI transition to the more severe stage (for patients with AKI at baseline).

    Time frame: from [start of treatment] through 28 days after

    Rate of worsening of acute kidney injury (AKI) in accordance with KDIGO AKI classification (Changing stages from 1 to 2, from 2 to 3).

  4. Serum creatinine change over time

    Time frame: from [start of treatment] through 28 days after

    Change of creatinine in serum over time for each patient and in average in group

  5. Serum urea change over time

    Time frame: from [start of treatment] through 28 days after

    Change of urea in serum over time for each patient and in average in group

  6. Urine output change

    Time frame: from [start of treatment] through 28 days after

    Change of urine output over time for each patient and in average in group

Secondary outcomes

  1. All-cause mortality

    Time frame: from [start of treatment] through 28 days after

    Mortality for any reasons for each patient and in average in group

  2. SOFA scores change

    Time frame: from [start of treatment] through 28 days after

    Change in SOFA scores over time for each patient and in average in group

  3. qSOFA scores change

    Time frame: from [start of treatment] through 28 days after

    Change in qSOFA scores over time for each patient and in average in group

Other outcomes

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

    Time frame: from [start of treatment] through 28 days after

    Change of NETs in blood over time for each patient and in average in group

Sponsors and collaborators

Lead sponsor

Santersus AG

Industry

Registry information

Official study title

Safety and Efficacy Assessment of NucleoCapture Selective DNA Adsorber in Humans

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 11, 2021
Registry last updated
Dec 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.