Clinical trial NCT04152174: Safety and Efficiency of Combined Extracorporeal Blood Purification in Neurosurgical ICU. Prospective RCT
Official title: Pilot Prospective Randomized Controlled Study of Safety and Efficiency of Combined Extracorporeal Blood Purification in Neurosurgical ICU in Comparison With the Continuous Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Keywords: blood purification
CRRT
septic shock
neurosurgery
cytokine removal
Lead sponsor: Burdenko Neurosurgery Institute
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* age \<18 years
* \>24 hours after diagnosis of septic shock

Primary outcomes:
measure: Vasopressor dose reduction
timeFrame: 6, 12, 24, 48 and 72 hours after the randomization time
measure: Time on vasopressor support
timeFrame: Up to 28 days after the randomization date
measure: SOFA score reduction
timeFrame: 24, 48 and 72 hours after the randomization time
Secondary outcomes:
measure: Interleukins concentration reduction
timeFrame: 6, 12, 24 and 48 hours after the randomization time
measure: Tumor necrosis factor-α concentration reduction
timeFrame: 6, 12, 24 and 48 hours after the randomization time
measure: Total bilirubin concentration reduction
timeFrame: 6, 12, 24 and 48 hours after the randomization time
measure: C - reactive protein level reduction
timeFrame: 24, 48 and 72 hours after the randomization time
measure: Procalcitonin concentration reduction
timeFrame: 6, 12, 24, 48 and 72 hours after the randomization time
measure: PiCCO-derived parameters normalization
timeFrame: 6, 12, 24, 48 and 72 hours after the randomization time
measure: Arteriovenous pCO2 gap reduction
timeFrame: 6, 12, 24, 48 and 72 hours after the randomization time
measure: Arterial blood lactate level reduction
timeFrame: 6, 12, 24, 48 and 72 hours after the randomization time
measure: ICU length of stay
timeFrame: up to 3 months after the randomization date
measure: Hospital stay time
timeFrame: up to 3 months after the randomization date
measure: Mechanical ventilation time
timeFrame: up to 3 months after the randomization date
measure: Continuous renal replacement therapy time
timeFrame: up to 3 months after the randomization date
Other outcomes:
measure: Intracranial hemorrhagic complication
timeFrame: in 48 hours after the randomization time
measure: Extracranial hemorrhagic complication
timeFrame: in 48 hours after the randomization time
measure: Death in 28-days after CRRT inititiation
timeFrame: 28-days after the randomization date
measure: In-hospital death
timeFrame: in 3 months after the randomization date
measure: Albumin blood level reduction
timeFrame: 24 and 48 hours after the randomization time
Locations:
city: Moscow
country: Russian Federation
facility: Federal State Autonomous Institution "N .N. Burdenko National Medical Research Center of Neurosurgery" of the Ministry of Healthcare of the Russian Federation
Study officials:
affiliation: N. N. Burdenko National Medical Research Center of Neurosurgery
name: Aleksandr Burov
role: STUDY_CHAIR
References: