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

Primary Purpose

Septic Shock

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Combined extracorporeal blood purification
CRRT
Sponsored by
Burdenko Neurosurgery Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring blood purification, CRRT, septic shock, neurosurgery, cytokine removal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal State Autonomous Institution "N .N. Burdenko National Medical Research Center of Neurosurgery" of the Ministry of Healthcare of the Russian FederationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined extracorporeal blood purification

Control

Arm Description

CRRT with CVVHDF mode plus treatment with CytSorb adsorber

CRRT with CVVHDF mode

Outcomes

Primary Outcome Measures

Vasopressor dose reduction
Vasopressor dose reduction value
Time on vasopressor support
Time on vasopressor support
SOFA score reduction
SOFA score reduction

Secondary Outcome Measures

Interleukins concentration reduction
Interleukins (IL-1β, IL-6, IL-8, IL-10) concentration reduction
Tumor necrosis factor-α concentration reduction
Tumor necrosis factor-α concentration reduction
Total bilirubin concentration reduction
Total bilirubin concentration reduction
C - reactive protein level reduction
C - reactive protein level reduction
Procalcitonin concentration reduction
Procalcitonin concentration reduction
PiCCO-derived parameters normalization
Any PiCCO-derived parameter normalization
Arteriovenous pCO2 gap reduction
Arteriovenous pCO2 gap reduction
Arterial blood lactate level reduction
Arterial blood lactate level reduction
ICU length of stay
ICU length of stay
Hospital stay time
Hospital stay time
Mechanical ventilation time
Mechanical ventilation time
Continuous renal replacement therapy time
Continuous renal replacement therapy time

Full Information

First Posted
September 21, 2019
Last Updated
August 31, 2021
Sponsor
Burdenko Neurosurgery Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04152174
Brief Title
Safety and Efficiency of Combined Extracorporeal Blood Purification in Neurosurgical ICU. Prospective RCT
Acronym
NEUROCOMB
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
September 10, 2021 (Anticipated)
Study Completion Date
November 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Burdenko Neurosurgery Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
blood purification, CRRT, septic shock, neurosurgery, cytokine removal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined extracorporeal blood purification
Arm Type
Experimental
Arm Description
CRRT with CVVHDF mode plus treatment with CytSorb adsorber
Arm Title
Control
Arm Type
Active Comparator
Arm Description
CRRT with CVVHDF mode
Intervention Type
Procedure
Intervention Name(s)
Combined extracorporeal blood purification
Intervention Description
Patients receive combined extracorporeal blood purification: CRRT in CVVHDF mode with AN 69 ST set (Baxter) and hemoadsorption with Cytosorbents Corp. CytoSorb adsorber.
Intervention Type
Procedure
Intervention Name(s)
CRRT
Intervention Description
Patients receive CRRT in CVVHDF mode with AN 69 ST set (Baxter)
Primary Outcome Measure Information:
Title
Vasopressor dose reduction
Description
Vasopressor dose reduction value
Time Frame
6, 12, 24, 48 and 72 hours after the randomization time
Title
Time on vasopressor support
Description
Time on vasopressor support
Time Frame
Up to 28 days after the randomization date
Title
SOFA score reduction
Description
SOFA score reduction
Time Frame
24, 48 and 72 hours after the randomization time
Secondary Outcome Measure Information:
Title
Interleukins concentration reduction
Description
Interleukins (IL-1β, IL-6, IL-8, IL-10) concentration reduction
Time Frame
6, 12, 24 and 48 hours after the randomization time
Title
Tumor necrosis factor-α concentration reduction
Description
Tumor necrosis factor-α concentration reduction
Time Frame
6, 12, 24 and 48 hours after the randomization time
Title
Total bilirubin concentration reduction
Description
Total bilirubin concentration reduction
Time Frame
6, 12, 24 and 48 hours after the randomization time
Title
C - reactive protein level reduction
Description
C - reactive protein level reduction
Time Frame
24, 48 and 72 hours after the randomization time
Title
Procalcitonin concentration reduction
Description
Procalcitonin concentration reduction
Time Frame
6, 12, 24, 48 and 72 hours after the randomization time
Title
PiCCO-derived parameters normalization
Description
Any PiCCO-derived parameter normalization
Time Frame
6, 12, 24, 48 and 72 hours after the randomization time
Title
Arteriovenous pCO2 gap reduction
Description
Arteriovenous pCO2 gap reduction
Time Frame
6, 12, 24, 48 and 72 hours after the randomization time
Title
Arterial blood lactate level reduction
Description
Arterial blood lactate level reduction
Time Frame
6, 12, 24, 48 and 72 hours after the randomization time
Title
ICU length of stay
Description
ICU length of stay
Time Frame
up to 3 months after the randomization date
Title
Hospital stay time
Description
Hospital stay time
Time Frame
up to 3 months after the randomization date
Title
Mechanical ventilation time
Description
Mechanical ventilation time
Time Frame
up to 3 months after the randomization date
Title
Continuous renal replacement therapy time
Description
Continuous renal replacement therapy time
Time Frame
up to 3 months after the randomization date
Other Pre-specified Outcome Measures:
Title
Intracranial hemorrhagic complication
Description
Presence of any intracranial hemorrhagic complications
Time Frame
in 48 hours after the randomization time
Title
Extracranial hemorrhagic complication
Description
Presence of extracranial hemorrhagic complications
Time Frame
in 48 hours after the randomization time
Title
Death in 28-days after CRRT inititiation
Description
28-days mortality in the observed sample group
Time Frame
28-days after the randomization date
Title
In-hospital death
Description
Hospital mortality in the observed sample group
Time Frame
in 3 months after the randomization date
Title
Albumin blood level reduction
Description
Albumin blood level reduction of more than 10%
Time Frame
24 and 48 hours after the randomization time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandr Burov
Phone
+79854215478
Email
Aleksander.bour@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Gleb Danilov, Phd
Email
gdanilov@nsi.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aleksandr Burov
Organizational Affiliation
N. N. Burdenko National Medical Research Center of Neurosurgery
Official's Role
Study Chair
Facility Information:
Facility Name
Federal State Autonomous Institution "N .N. Burdenko National Medical Research Center of Neurosurgery" of the Ministry of Healthcare of the Russian Federation
City
Moscow
ZIP/Postal Code
125047
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aleksandr Burov
Phone
+79854215478
Email
Aleksander.bour@mail.ru

12. IPD Sharing Statement

Plan to Share IPD
No

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

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