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

• Sponsor: Burdenko Neurosurgery Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04152174
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 43
• Patients Per Site Per Month: 0.3

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Septic Shock	Procedure: Combined extracorporeal blood purification; Procedure: CRRT	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• 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: Apr 10, 2018
• Anticipated Primary Completion Date: Sep 10, 2021
• Anticipated Study Completion Date: Nov 10, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Vasopressor dose reduction [6, 12, 24, 48 and 72 hours after the randomization time]

   Vasopressor dose reduction value

2. Time on vasopressor support [Up to 28 days after the randomization date]

   Time on vasopressor support

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

   SOFA score reduction

Secondary Outcome Measures

1. Interleukins concentration reduction [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 [6, 12, 24 and 48 hours after the randomization time]

   Tumor necrosis factor-α concentration reduction

3. Total bilirubin concentration reduction [6, 12, 24 and 48 hours after the randomization time]

   Total bilirubin concentration reduction

4. C - reactive protein level reduction [24, 48 and 72 hours after the randomization time]

   C - reactive protein level reduction

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

   Procalcitonin concentration reduction

6. PiCCO-derived parameters normalization [6, 12, 24, 48 and 72 hours after the randomization time]

   Any PiCCO-derived parameter normalization

7. Arteriovenous pCO2 gap reduction [6, 12, 24, 48 and 72 hours after the randomization time]

   Arteriovenous pCO2 gap reduction

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

   Arterial blood lactate level reduction

9. ICU length of stay [up to 3 months after the randomization date]

   ICU length of stay

10. Hospital stay time [up to 3 months after the randomization date]

    Hospital stay time

11. Mechanical ventilation time [up to 3 months after the randomization date]

    Mechanical ventilation time

12. Continuous renal replacement therapy time [up to 3 months after the randomization date]

    Continuous renal replacement therapy time

Other Outcome Measures

1. Intracranial hemorrhagic complication [in 48 hours after the randomization time]

   Presence of any intracranial hemorrhagic complications

2. Extracranial hemorrhagic complication [in 48 hours after the randomization time]

   Presence of extracranial hemorrhagic complications

3. Death in 28-days after CRRT inititiation [28-days after the randomization date]

   28-days mortality in the observed sample group

4. In-hospital death [in 3 months after the randomization date]

   Hospital mortality in the observed sample group

5. Albumin blood level reduction [24 and 48 hours after the randomization time]

   Albumin blood level reduction of more than 10%

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	125047

Sponsors and Collaborators

• Burdenko Neurosurgery Institute

Investigators

• Study Chair: Aleksandr Burov, N. N. Burdenko National Medical Research Center of Neurosurgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Burdenko Neurosurgery Institute
• ClinicalTrials.gov Identifier: NCT04152174
• Other Study ID Numbers: PPI-2018-06-5
• First Posted: Nov 5, 2019
• Last Update Posted: Sep 5, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Shock, Septic

Study Results

No Results Posted as of Sep 5, 2021