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

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ClinicalTrials.gov Identifier: NCT04749238
Recruitment Status : Recruiting
First Posted : February 11, 2021
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Santersus AG

Study Description
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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).

Condition or disease Intervention/treatment Phase
Sepsis Sepsis-associated AKI Device: NucleoCapture device Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Assessment of NucleoCapture Selective DNA Adsorber in Humans
Actual Study Start Date : July 16, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment with NucleoCapture device
Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm.
 Device: NucleoCapture device
Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm
Other Name: NucleoCapture selective DNA adsorber


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04749238


Contacts
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Contact: Sergey Avtushenko, MD +78123375866 SA@santersus.com

Locations
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Russian Federation
North-Western Regional Scientific and Clinical Center named after L.G. Sokolov Recruiting
Saint- Petersburg, Russian Federation
Contact: Stanislav Abramovskiy, MD         
Sponsors and Collaborators
Santersus AG
More Information
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Responsible Party: Santersus AG
ClinicalTrials.gov Identifier: NCT04749238    
Other Study ID Numbers: Nucleo 514/2020
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes