Back to resultsEffect of Extracorporeal Adsorption of Plasma Neutrophil Extracellular Traps (NET) in Sepsis
Primary Purpose
Sepsis, Sepsis-associated AKI
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
NucleoCapture device
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis
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
Sites / Locations
- North-Western Regional Scientific and Clinical Center named after L.G. Sokolov
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with NucleoCapture device
Arm Description
Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm.
Outcomes
Primary Outcome Measures
Incidence of acute kidney injury (AKI)
Incidence of acute kidney injury (AKI) in accordance with Kidney Disease Improving Global Outcomes (KDIGO) definitions for AKI
Severity of acute kidney injury (AKI)
Severity of acute kidney injury (AKI) in accordance with KDIGO definitions for AKI
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).
Serum creatinine change over time
Change of creatinine in serum over time for each patient and in average in group
Serum urea change over time
Change of urea in serum over time for each patient and in average in group
Urine output change
Change of urine output over time for each patient and in average in group
Secondary Outcome Measures
All-cause mortality
Mortality for any reasons for each patient and in average in group
SOFA scores change
Change in SOFA scores over time for each patient and in average in group
qSOFA scores change
Change in qSOFA scores over time for each patient and in average in group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04749238
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
October 24, 2021 (Actual)
Study Completion Date
October 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santersus AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Sepsis-associated AKI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with NucleoCapture device
Arm Type
Experimental
Arm Description
Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm.
Intervention Type
Device
Intervention Name(s)
NucleoCapture device
Other Intervention Name(s)
NucleoCapture selective DNA adsorber
Intervention Description
Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm
Primary Outcome Measure Information:
Title
Incidence of acute kidney injury (AKI)
Description
Incidence of acute kidney injury (AKI) in accordance with Kidney Disease Improving Global Outcomes (KDIGO) definitions for AKI
Time Frame
from [start of treatment] through 28 days after
Title
Severity of acute kidney injury (AKI)
Description
Severity of acute kidney injury (AKI) in accordance with KDIGO definitions for AKI
Time Frame
from [start of treatment] through 28 days after
Title
Rate of AKI transition to the more severe stage (for patients with AKI at baseline).
Description
Rate of worsening of acute kidney injury (AKI) in accordance with KDIGO AKI classification (Changing stages from 1 to 2, from 2 to 3).
Time Frame
from [start of treatment] through 28 days after
Title
Serum creatinine change over time
Description
Change of creatinine in serum over time for each patient and in average in group
Time Frame
from [start of treatment] through 28 days after
Title
Serum urea change over time
Description
Change of urea in serum over time for each patient and in average in group
Time Frame
from [start of treatment] through 28 days after
Title
Urine output change
Description
Change of urine output over time for each patient and in average in group
Time Frame
from [start of treatment] through 28 days after
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
Mortality for any reasons for each patient and in average in group
Time Frame
from [start of treatment] through 28 days after
Title
SOFA scores change
Description
Change in SOFA scores over time for each patient and in average in group
Time Frame
from [start of treatment] through 28 days after
Title
qSOFA scores change
Description
Change in qSOFA scores over time for each patient and in average in group
Time Frame
from [start of treatment] through 28 days after
Other Pre-specified Outcome Measures:
Title
Blood level of neutrophil extracellular traps (NETs) change over time
Description
Change of NETs in blood over time for each patient and in average in group
Time Frame
from [start of treatment] through 28 days after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
North-Western Regional Scientific and Clinical Center named after L.G. Sokolov
City
Saint- Petersburg
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Extracorporeal Adsorption of Plasma Neutrophil Extracellular Traps (NET) in Sepsis
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