Sepsis, Sepsis-associated AKI
Conditions
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.
Interventions
DEVICENucleoCapture device
Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm
Sponsors
Santersus AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urine output change | from [start of treatment] through 28 days after | Change of urine output over time for each patient and in average in group |
| Severity of acute kidney injury (AKI) | from [start of treatment] through 28 days after | 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). | 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). |
| Serum creatinine change over time | from [start of treatment] through 28 days after | Change of creatinine in serum over time for each patient and in average in group |
| Serum urea change over time | from [start of treatment] through 28 days after | Change of urea in serum over time for each patient and in average in group |
| Incidence of acute kidney injury (AKI) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | from [start of treatment] through 28 days after | Mortality for any reasons for each patient and in average in group |
| SOFA scores change | from [start of treatment] through 28 days after | Change in SOFA scores over time for each patient and in average in group |
| qSOFA scores change | from [start of treatment] through 28 days after | Change in qSOFA scores over time for each patient and in average in group |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood level of neutrophil extracellular traps (NETs) change over time | from [start of treatment] through 28 days after | Change of NETs in blood over time for each patient and in average in group |
Countries
Russia
Outcome results
None listed