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

Sepsis Clinical Trial

Official title:

Safety and Efficacy Assessment of NucleoCapture Selective DNA Adsorber in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749238
• Other study ID #: Nucleo 514/2020
• Status: Completed
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: October 24, 2021

Study information

• Verified date: December 2022
• Source: Santersus AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 24, 2021
• Est. primary completion date: October 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Sepsis-associated AKI
• Toxemia

Intervention

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

Locations

Country	Name	City	State
Russian Federation	North-Western Regional Scientific and Clinical Center named after L.G. Sokolov	Saint- Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Santersus AG

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	All-cause mortality	Mortality for any reasons for each patient and in average in group	from [start of treatment] through 28 days after
Secondary	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
Secondary	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