Septic Shock
Conditions
Keywords
blood purification, CRRT, septic shock, neurosurgery, cytokine removal
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.
Interventions
PROCEDURECombined extracorporeal blood purification
Patients receive combined extracorporeal blood purification: CRRT in CVVHDF mode with AN 69 ST set (Baxter) and hemoadsorption with Cytosorbents Corp. CytoSorb adsorber.
PROCEDURECRRT
Patients receive CRRT in CVVHDF mode with AN 69 ST set (Baxter)
Sponsors
Burdenko Neurosurgery Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SOFA score reduction | 24, 48 and 72 hours after the randomization time | SOFA score reduction |
| Time on vasopressor support | Up to 28 days after the randomization date | Time on vasopressor support |
| Vasopressor dose reduction | 6, 12, 24, 48 and 72 hours after the randomization time | Vasopressor dose reduction value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PiCCO-derived parameters normalization | 6, 12, 24, 48 and 72 hours after the randomization time | Any PiCCO-derived parameter normalization |
| 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 |
| 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 |
| Continuous renal replacement therapy time | up to 3 months after the randomization date | Continuous renal replacement therapy time |
| 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 |
| Total bilirubin concentration reduction | 6, 12, 24 and 48 hours after the randomization time | Total bilirubin concentration reduction |
| C - reactive protein level reduction | 24, 48 and 72 hours after the randomization time | C - reactive protein level reduction |
| Procalcitonin concentration reduction | 6, 12, 24, 48 and 72 hours after the randomization time | Procalcitonin concentration reduction |
| Arteriovenous pCO2 gap reduction | 6, 12, 24, 48 and 72 hours after the randomization time | Arteriovenous pCO2 gap reduction |
Other
| Measure | Time frame | Description |
|---|---|---|
| Albumin blood level reduction | 24 and 48 hours after the randomization time | Albumin blood level reduction of more than 10% |
| Extracranial hemorrhagic complication | in 48 hours after the randomization time | Presence of extracranial hemorrhagic complications |
| Intracranial hemorrhagic complication | in 48 hours after the randomization time | Presence of any intracranial hemorrhagic complications |
| In-hospital death | in 3 months after the randomization date | Hospital mortality in the observed sample group |
| Death in 28-days after CRRT inititiation | 28-days after the randomization date | 28-days mortality in the observed sample group |
Countries
Russia
Contacts
Primary ContactAleksandr Burov
Backup ContactGleb Danilov, Phd
Outcome results
None listed