North-Western Regional Scientific and Clinical Center named after L.G. Sokolov
Saint Petersburg, Russia
NCT Number: NCT04749238
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).
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Saint Petersburg, Russia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm
Other names: NucleoCapture selective DNA adsorber
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
Time frame: from [start of treatment] through 28 days after
Severity of acute kidney injury (AKI) in accordance with KDIGO definitions for AKI
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).
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
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
Time frame: from [start of treatment] through 28 days after
Change of urine output over time for each patient and in average in group
Time frame: from [start of treatment] through 28 days after
Mortality for any reasons for each patient and in average in group
Time frame: from [start of treatment] through 28 days after
Change in SOFA scores over time for each patient and in average in group
Time frame: from [start of treatment] through 28 days after
Change in qSOFA scores over time for each patient and in average in group
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
Santersus AG
Industry
Safety and Efficacy Assessment of NucleoCapture Selective DNA Adsorber in Humans
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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.
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