Septic ShockNEUROCOMBNCT04152174
Safety and Efficiency of Combined Extracorporeal Blood Purification in Neurosurgical ICU. Prospective RCT
A study testing Combined extracorporeal blood purification and CRRT in people with Septic Shock, run by Burdenko Neurosurgery Institute at 1 site in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Combined extracorporeal blood purification and CRRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteRussia
- Study dates
- 10 Apr 2018to 10 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age <18 years
- >24 hours after diagnosis of septic shock
Trial locations and contacts
1 site in 1 country.
Gleb Danilov, Phd contact
Russia1 site, 1 recruiting
- Recruiting
Federal State Autonomous Institution "N .N. Burdenko National Medical Research Center of Neurosurgery" of the Ministry of Healthcare of the Russian Federation
Moscow, 125047
Aleksandr Burov, +79854215478, Aleksander.bour@mail.ru
About this study
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
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).
Read the 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.
- Conditions
- Septic Shock
- Being tested
- Combined extracorporeal blood purification, CRRT
- Keywords
- blood purification, CRRT, septic shock, neurosurgery, cytokine removal
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined extracorporeal blood purificationProcedure or surgery
Patients receive combined extracorporeal blood purification: CRRT in CVVHDF mode with AN 69 ST set (Baxter) and hemoadsorption with Cytosorbents Corp. CytoSorb adsorber.
CRRTProcedure or surgery
Patients receive CRRT in CVVHDF mode with AN 69 ST set (Baxter)
| Study group | Role | What they receive |
|---|---|---|
| Combined extracorporeal blood purification | Experimental | CRRT with CVVHDF mode plus treatment with CytSorb adsorber Receives: Procedure: Combined extracorporeal blood purification |
| Control | Active comparator | CRRT with CVVHDF mode Receives: Procedure: CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressor dose reduction
Vasopressor dose reduction value
Measured: 6, 12, 24, 48 and 72 hours after the randomization time
Time on vasopressor support
Time on vasopressor support
Measured: Up to 28 days after the randomization date
SOFA score reduction
SOFA score reduction
Measured: 24, 48 and 72 hours after the randomization time
Secondary outcomes (12)
Interleukins concentration reduction
Interleukins (IL-1β, IL-6, IL-8, IL-10) concentration reduction
Measured: 6, 12, 24 and 48 hours after the randomization time
Tumor necrosis factor-α concentration reduction
Tumor necrosis factor-α concentration reduction
Measured: 6, 12, 24 and 48 hours after the randomization time
Total bilirubin concentration reduction
Total bilirubin concentration reduction
Measured: 6, 12, 24 and 48 hours after the randomization time
C - reactive protein level reduction
C - reactive protein level reduction
Measured: 24, 48 and 72 hours after the randomization time
Procalcitonin concentration reduction
Procalcitonin concentration reduction
Measured: 6, 12, 24, 48 and 72 hours after the randomization time
PiCCO-derived parameters normalization
Any PiCCO-derived parameter normalization
Measured: 6, 12, 24, 48 and 72 hours after the randomization time
Arteriovenous pCO2 gap reduction
Arteriovenous pCO2 gap reduction
Measured: 6, 12, 24, 48 and 72 hours after the randomization time
Arterial blood lactate level reduction
Arterial blood lactate level reduction
Measured: 6, 12, 24, 48 and 72 hours after the randomization time
ICU length of stay
ICU length of stay
Measured: up to 3 months after the randomization date
Hospital stay time
Hospital stay time
Measured: up to 3 months after the randomization date
Mechanical ventilation time
Mechanical ventilation time
Measured: up to 3 months after the randomization date
Continuous renal replacement therapy time
Continuous renal replacement therapy time
Measured: up to 3 months after the randomization date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start10 Apr 2018
- Primary completion10 Sep 2021 (estimated)
- Study completion10 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burdenko Neurosurgery Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aleksandr Burov, Study chair, N. N. Burdenko National Medical Research Center of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152174
- Sponsor's protocol ID
- PPI-2018-06-5
- Acronym
- NEUROCOMB
- Status last verified
- Aug 2021
- First submitted
- 21 Sep 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04152174
- Acronym / sponsor ID
- NEUROCOMB / PPI-2018-06-5
- Conditions
- Septic Shock
- Keywords
- blood purification, CRRT, septic shock, neurosurgery, cytokine removal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Burdenko Neurosurgery InstituteUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 10 Sep 2021 (estimated)
- Study completion
- 10 Nov 2021 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined extracorporeal blood purification | Experimental | Procedure: Combined extracorporeal blood purificationCRRT with CVVHDF mode plus treatment with CytSorb adsorber |
| Control | Active comparator | Procedure: CRRTCRRT with CVVHDF mode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- age <18 years
- >24 hours after diagnosis of septic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined extracorporeal blood purificationPatients receive combined extracorporeal blood purification: CRRT in CVVHDF mode with AN 69 ST set (Baxter) and hemoadsorption with Cytosorbents Corp. CytoSorb adsorber. | Procedure or surgery | Combined extracorporeal blood purification |
| CRRTPatients receive CRRT in CVVHDF mode with AN 69 ST set (Baxter) | Procedure or surgery | Control |
Primary outcome
Vasopressor dose reduction
Time frame: 6, 12, 24, 48 and 72 hours after the randomization time
Vasopressor dose reduction value
Time on vasopressor support
Time frame: Up to 28 days after the randomization date
Time on vasopressor support
SOFA score reduction
Time frame: 24, 48 and 72 hours after the randomization time
SOFA score reduction
12 secondary outcomes
Interleukins concentration reduction
Time frame: 6, 12, 24 and 48 hours after the randomization time
Tumor necrosis factor-α concentration reduction
Time frame: 6, 12, 24 and 48 hours after the randomization time
Total bilirubin concentration reduction
Time frame: 6, 12, 24 and 48 hours after the randomization time
C - reactive protein level reduction
Time frame: 24, 48 and 72 hours after the randomization time
Procalcitonin concentration reduction
Time frame: 6, 12, 24, 48 and 72 hours after the randomization time
PiCCO-derived parameters normalization
Time frame: 6, 12, 24, 48 and 72 hours after the randomization time
Arteriovenous pCO2 gap reduction
Time frame: 6, 12, 24, 48 and 72 hours after the randomization time
Arterial blood lactate level reduction
Time frame: 6, 12, 24, 48 and 72 hours after the randomization time
ICU length of stay
Time frame: up to 3 months after the randomization date
Hospital stay time
Time frame: up to 3 months after the randomization date
Mechanical ventilation time
Time frame: up to 3 months after the randomization date
Continuous renal replacement therapy time
Time frame: up to 3 months after the randomization date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
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Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gleb Danilov, Phd contact
Aleksandr Burov study chair
N. N. Burdenko National Medical Research Center of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined extracorporeal blood purification and CRRT in people with Septic Shock, run by Burdenko Neurosurgery Institute at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandr Burov (+79854215478, Aleksander.bour@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasopressor dose reduction (time frame: 6, 12, 24, 48 and 72 hours after the randomization time). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.