Clinical trial NCT04749238: Effect of Extracorporeal Adsorption of Plasma Neutrophil Extracellular Traps (NET) in Sepsis
Official title: Safety and Efficacy Assessment of NucleoCapture Selective DNA Adsorber in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Sepsis-associated AKI
Lead sponsor: Santersus AG
Sponsor class: INDUSTRY
First posted: 2021-02-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of acute kidney injury (AKI)
timeFrame: from [start of treatment] through 28 days after
measure: Severity of acute kidney injury (AKI)
timeFrame: from [start of treatment] through 28 days after
measure: Rate of AKI transition to the more severe stage (for patients with AKI at baseline).
timeFrame: from [start of treatment] through 28 days after
measure: Serum creatinine change over time
timeFrame: from [start of treatment] through 28 days after
measure: Serum urea change over time
timeFrame: from [start of treatment] through 28 days after
measure: Urine output change
timeFrame: from [start of treatment] through 28 days after
Secondary outcomes:
measure: All-cause mortality
timeFrame: from [start of treatment] through 28 days after
measure: SOFA scores change
timeFrame: from [start of treatment] through 28 days after
measure: qSOFA scores change
timeFrame: from [start of treatment] through 28 days after
Other outcomes:
measure: Blood level of neutrophil extracellular traps (NETs) change over time
timeFrame: from [start of treatment] through 28 days after
Locations:
city: Saint- Petersburg
country: Russian Federation
facility: North-Western Regional Scientific and Clinical Center named after L.G. Sokolov
Study officials:
References: