To assess the efficiency and safety of combined extracorporeal blood purification in patients with septic shock in Neurosurgical ICU in comparison with the efficiency and safety of the continuous renal replacement therapy (CRRT).
According to studies and modern sepsis treatment guidelines, conventional CRRT has not proved effective in the septic shock treatment. Effectiveness of other extracoporeal blood purification methods, such as hemoadsorption or combined blood purification (hemoadsorption combined with CRRT) is widely pointed out in current publications: contemporary studies in general ICU patients demonstrated that the use of hemoadsorption or combined extracorporeal blood purification methods is effective for septic shock patients treatment. It has been proven that cytokines discharged into the systemic blood flow are the key pathophysiological mechanism of septic shock. Hemoadsorption allows for significantly more effective removal of different inflammatory mediators than the traditional methods of CRRT. The combined extracorporeal blood purification method demonstrated similar efficacy in general ICU patients. The aim of this study is to assess the efficiency and safety of combined extracorporeal blood purification in with septic shock in neurosurgical ICU in comparison with the efficiency and safety of the continuous renal replacement therapy (CRRT) with AN69 membrane. Study novelty: We have not encountered published studies evaluating the efficiency of combined extracorporeal blood purification methods in neurosurgical patients with septic shock. Furthermore, currently there is not enough data to compare combined extracorporeal blood purification with CRRT for septic shock treatment. The planned study is the first to investigate the safety and efficiency of combined extracorporeal blood purification in patients with septic shock in neurosurgical ICU.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
14
Patients receive combined extracorporeal blood purification: CRRT in CVVHDF mode with AN 69 ST set (Baxter) and hemoadsorption with Cytosorbents Corp. CytoSorb adsorber.
Patients receive CRRT in CVVHDF mode with AN 69 ST set (Baxter)
Federal State Autonomous Institution "N .N. Burdenko National Medical Research Center of Neurosurgery" of the Ministry of Healthcare of the Russian Federation
Moscow, Russia
RECRUITINGVasopressor dose reduction
Vasopressor dose reduction value
Time frame: 6, 12, 24, 48 and 72 hours after the randomization time
Time on vasopressor support
Time on vasopressor support
Time frame: Up to 28 days after the randomization date
SOFA score reduction
SOFA score reduction
Time frame: 24, 48 and 72 hours after the randomization time
Interleukins concentration reduction
Interleukins (IL-1β, IL-6, IL-8, IL-10) concentration reduction
Time frame: 6, 12, 24 and 48 hours after the randomization time
Tumor necrosis factor-α concentration reduction
Tumor necrosis factor-α concentration reduction
Time frame: 6, 12, 24 and 48 hours after the randomization time
Total bilirubin concentration reduction
Total bilirubin concentration reduction
Time frame: 6, 12, 24 and 48 hours after the randomization time
C - reactive protein level reduction
C - reactive protein level reduction
Time frame: 24, 48 and 72 hours after the randomization time
Procalcitonin concentration reduction
Procalcitonin concentration reduction
Time frame: 6, 12, 24, 48 and 72 hours after the randomization time
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PiCCO-derived parameters normalization
Any PiCCO-derived parameter normalization
Time frame: 6, 12, 24, 48 and 72 hours after the randomization time
Arteriovenous pCO2 gap reduction
Arteriovenous pCO2 gap reduction
Time frame: 6, 12, 24, 48 and 72 hours after the randomization time
Arterial blood lactate level reduction
Arterial blood lactate level reduction
Time frame: 6, 12, 24, 48 and 72 hours after the randomization time
ICU length of stay
ICU length of stay
Time frame: up to 3 months after the randomization date
Hospital stay time
Hospital stay time
Time frame: up to 3 months after the randomization date
Mechanical ventilation time
Mechanical ventilation time
Time frame: up to 3 months after the randomization date
Continuous renal replacement therapy time
Continuous renal replacement therapy time
Time frame: up to 3 months after the randomization date