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Safety and Efficiency of Combined Extracorporeal Blood Purification in Neurosurgical ICU. Prospective RCT (NEUROCOMB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04152174
Recruitment Status : Recruiting
First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Septic Shock Procedure: Combined extracorporeal blood purification Procedure: CRRT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : April 10, 2018
Estimated Primary Completion Date : April 10, 2021
Estimated Study Completion Date : May 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Combined extracorporeal blood purification
CRRT with CVVHDF mode plus treatment with CytSorb adsorber
Procedure: Combined 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.

Active Comparator: Control
CRRT with CVVHDF mode
Procedure: CRRT
Patients receive CRRT in CVVHDF mode with AN 69 ST set (Baxter)




Primary Outcome Measures :
  1. Vasopressor dose reduction [ Time Frame: 6, 12, 24, 48 and 72 hours after the randomization time ]
    Vasopressor dose reduction value

  2. Time on vasopressor support [ Time Frame: Up to a month after the randomization date ]
    Time on vasopressor support


Secondary Outcome Measures :
  1. Interleukins concentration reduction [ Time Frame: 6, 12, 24 and 48 hours after the randomization time ]
    Interleukins (IL-1β, IL-6, IL-8, IL-10) concentration reduction

  2. Tumor necrosis factor-α concentration reduction [ Time Frame: 6, 12, 24 and 48 hours after the randomization time ]
    Tumor necrosis factor-α concentration reduction

  3. SOFA score reduction [ Time Frame: 24, 48 and 72 hours after the randomization time ]
    SOFA score reduction

  4. Total bilirubin concentration reduction [ Time Frame: 6, 12, 24 and 48 hours after the randomization time ]
    Total bilirubin concentration reduction

  5. C - reactive protein level reduction [ Time Frame: 24, 48 and 72 hours after the randomization time ]
    C - reactive protein level reduction

  6. Procalcitonin concentration reduction [ Time Frame: 6, 12, 24, 48 and 72 hours after the randomization time ]
    Procalcitonin concentration reduction

  7. PiCCO-derived parameters normalization [ Time Frame: 6, 12, 24, 48 and 72 hours after the randomization time ]
    Any PiCCO-derived parameter normalization

  8. Arteriovenous pCO2 gap reduction [ Time Frame: 6, 12, 24, 48 and 72 hours after the randomization time ]
    Arteriovenous pCO2 gap reduction

  9. Arterial blood lactate level reduction [ Time Frame: 6, 12, 24, 48 and 72 hours after the randomization time ]
    Arterial blood lactate level reduction

  10. ICU length of stay [ Time Frame: up to 3 months after the randomization date ]
    ICU length of stay

  11. Hospital stay time [ Time Frame: up to 3 months after the randomization date ]
    Hospital stay time

  12. Mechanical ventilation time [ Time Frame: up to 3 months after the randomization date ]
    Mechanical ventilation time

  13. Continuous renal replacement therapy time [ Time Frame: up to 3 months after the randomization date ]
    Continuous renal replacement therapy time


Other Outcome Measures:
  1. Intracranial hemorrhagic complication [ Time Frame: in 48 hours after the randomization time ]
    Presence of any intracranial hemorrhagic complications

  2. Extracranial hemorrhagic complication [ Time Frame: in 48 hours after the randomization time ]
    Presence of extracranial hemorrhagic complications

  3. Death in 28-days after CRRT inititiation [ Time Frame: 28-days after the randomization date ]
    28-days mortality in the observed sample group

  4. In-hospital death [ Time Frame: in 3 months after the randomization date ]
    Hospital mortality in the observed sample group

  5. Albumin blood level reduction [ Time Frame: 24 and 48 hours after the randomization time ]
    Albumin blood level reduction of more than 10%



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • patients, who undergo neurosurgical interventions in the operation theatre during the study
  • age <18 years
  • >24 hours after diagnosis of septic shock

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04152174


Contacts
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Contact: Aleksandr Burov +79854215478 Aleksander.bour@mail.ru
Contact: Gleb Danilov, Phd gdanilov@nsi.ru

Locations
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Russian Federation
Federal State Autonomous Institution "N .N. Burdenko National Medical Research Center of Neurosurgery" of the Ministry of Healthcare of the Russian Federation Recruiting
Moscow, Russian Federation, 125047
Contact: Aleksandr Burov    +79854215478    Aleksander.bour@mail.ru   
Sponsors and Collaborators
Burdenko Neurosurgery Institute
Investigators
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Study Chair: Aleksandr Burov N. N. Burdenko National Medical Research Center of Neurosurgery

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Responsible Party: Burdenko Neurosurgery Institute
ClinicalTrials.gov Identifier: NCT04152174    
Other Study ID Numbers: PPI-2018-06-5
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Burdenko Neurosurgery Institute:
blood purification
CRRT
septic shock
neurosurgery
cytokine removal
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation