NCT04152174

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

3.4 years

First QC Date

September 21, 2019

Last Update Submit

August 31, 2021

Conditions

Septic Shock

Keywords

blood purificationCRRTseptic shockneurosurgerycytokine removal

Outcome Measures

Primary Outcomes (3)

  • Vasopressor dose reduction

    Vasopressor dose reduction value

    6, 12, 24, 48 and 72 hours after the randomization time

  • Time on vasopressor support

    Time on vasopressor support

    Up to 28 days after the randomization date

  • SOFA score reduction

    SOFA score reduction

    24, 48 and 72 hours after the randomization time

Secondary Outcomes (12)

  • Interleukins concentration reduction

    6, 12, 24 and 48 hours after the randomization time

  • Tumor necrosis factor-α concentration reduction

    6, 12, 24 and 48 hours after the randomization time

  • Total bilirubin concentration reduction

    6, 12, 24 and 48 hours after the randomization time

  • C - reactive protein level reduction

    24, 48 and 72 hours after the randomization time

  • Procalcitonin concentration reduction

    6, 12, 24, 48 and 72 hours after the randomization time

  • +7 more secondary outcomes

Other Outcomes (5)

  • Intracranial hemorrhagic complication

    in 48 hours after the randomization time

  • Extracranial hemorrhagic complication

    in 48 hours after the randomization time

  • Death in 28-days after CRRT inititiation

    28-days after the randomization date

  • +2 more other outcomes

Study Arms (2)

Combined extracorporeal blood purification

EXPERIMENTAL

CRRT with CVVHDF mode plus treatment with CytSorb adsorber

Procedure: Combined extracorporeal blood purification

Control

ACTIVE COMPARATOR

CRRT with CVVHDF mode

Procedure: CRRT

Interventions

Combined extracorporeal blood purificationPROCEDURE

Patients receive combined extracorporeal blood purification: CRRT in CVVHDF mode with AN 69 ST set (Baxter) and hemoadsorption with Cytosorbents Corp. CytoSorb adsorber.

Combined extracorporeal blood purification
CRRTPROCEDURE

Patients receive CRRT in CVVHDF mode with AN 69 ST set (Baxter)

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, 125047, Russia

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Aleksandr Burov

    N. N. Burdenko National Medical Research Center of Neurosurgery

    STUDY CHAIR

Central Study Contacts

Aleksandr Burov

CONTACT

+79854215478Aleksander.bour@mail.ru

Gleb Danilov, Phd

CONTACT

gdanilov@nsi.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2019

First Posted

November 5, 2019

Study Start

April 10, 2018

Primary Completion

September 10, 2021

Study Completion

November 10, 2021

Last Updated

September 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)