Safety and Efficiency of Combined Extracorporeal Blood Purification in Neurosurgical ICU. Prospective RCT
- Conditions
- Septic Shock
- Interventions
- Procedure: Combined extracorporeal blood purificationProcedure: CRRT
- Registration Number
- NCT04152174
- Lead Sponsor
- Burdenko Neurosurgery Institute
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 14
- diagnosis of septic shock according to SEPSIS 3 definition
- Glasgow Coma Scale of 4 and more on admission
- invasive hemodynamics monitoring
- norepinephrine > 0,1 µg/kg/min or use of 2 vasopressors
- age <18 years
- >24 hours after diagnosis of septic shock
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combined extracorporeal blood purification Combined extracorporeal blood purification CRRT with CVVHDF mode plus treatment with CytSorb adsorber Control CRRT CRRT with CVVHDF mode
- Primary Outcome Measures
Name Time Method Vasopressor dose reduction 6, 12, 24, 48 and 72 hours after the randomization time Vasopressor dose reduction value
Time on vasopressor support Up to 28 days after the randomization date Time on vasopressor support
SOFA score reduction 24, 48 and 72 hours after the randomization time SOFA score reduction
- Secondary Outcome Measures
Name Time Method Hospital stay time up to 3 months after the randomization date Hospital stay time
Mechanical ventilation time up to 3 months after the randomization date Mechanical ventilation time
C - reactive protein level reduction 24, 48 and 72 hours after the randomization time C - reactive protein level reduction
Arteriovenous pCO2 gap reduction 6, 12, 24, 48 and 72 hours after the randomization time Arteriovenous pCO2 gap reduction
Interleukins concentration reduction 6, 12, 24 and 48 hours after the randomization time Interleukins (IL-1β, IL-6, IL-8, IL-10) concentration reduction
Tumor necrosis factor-α concentration reduction 6, 12, 24 and 48 hours after the randomization time Tumor necrosis factor-α concentration reduction
PiCCO-derived parameters normalization 6, 12, 24, 48 and 72 hours after the randomization time Any PiCCO-derived parameter normalization
Procalcitonin concentration reduction 6, 12, 24, 48 and 72 hours after the randomization time Procalcitonin concentration reduction
Total bilirubin concentration reduction 6, 12, 24 and 48 hours after the randomization time Total bilirubin concentration reduction
Arterial blood lactate level reduction 6, 12, 24, 48 and 72 hours after the randomization time Arterial blood lactate level reduction
ICU length of stay up to 3 months after the randomization date ICU length of stay
Continuous renal replacement therapy time up to 3 months after the randomization date Continuous renal replacement therapy time
Trial Locations
- Locations (1)
Federal State Autonomous Institution "N .N. Burdenko National Medical Research Center of Neurosurgery" of the Ministry of Healthcare of the Russian Federation
🇷🇺Moscow, Russian Federation