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

Septic Shock Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04152174
• Other study ID #: PPI-2018-06-5
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2018
• Est. completion date: November 10, 2021

Study information

• Verified date: August 2021
• Source: Burdenko Neurosurgery Institute
• Contact: Aleksandr Burov
• Phone: +79854215478
• Email: Aleksander.bour[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: November 10, 2021
• Est. primary completion date: September 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Burdenko Neurosurgery Institute

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intracranial hemorrhagic complication	Presence of any intracranial hemorrhagic complications	in 48 hours after the randomization time
Other	Extracranial hemorrhagic complication	Presence of extracranial hemorrhagic complications	in 48 hours after the randomization time
Other	Death in 28-days after CRRT inititiation	28-days mortality in the observed sample group	28-days after the randomization date
Other	In-hospital death	Hospital mortality in the observed sample group	in 3 months after the randomization date
Other	Albumin blood level reduction	Albumin blood level reduction of more than 10%	24 and 48 hours after the randomization time
Primary	Vasopressor dose reduction	Vasopressor dose reduction value	6, 12, 24, 48 and 72 hours after the randomization time
Primary	Time on vasopressor support	Time on vasopressor support	Up to 28 days after the randomization date
Primary	SOFA score reduction	SOFA score reduction	24, 48 and 72 hours after the randomization time
Secondary	Interleukins concentration reduction	Interleukins (IL-1ß, IL-6, IL-8, IL-10) concentration reduction	6, 12, 24 and 48 hours after the randomization time
Secondary	Tumor necrosis factor-a concentration reduction	Tumor necrosis factor-a concentration reduction	6, 12, 24 and 48 hours after the randomization time
Secondary	Total bilirubin concentration reduction	Total bilirubin concentration reduction	6, 12, 24 and 48 hours after the randomization time
Secondary	C - reactive protein level reduction	C - reactive protein level reduction	24, 48 and 72 hours after the randomization time
Secondary	Procalcitonin concentration reduction	Procalcitonin concentration reduction	6, 12, 24, 48 and 72 hours after the randomization time
Secondary	PiCCO-derived parameters normalization	Any PiCCO-derived parameter normalization	6, 12, 24, 48 and 72 hours after the randomization time
Secondary	Arteriovenous pCO2 gap reduction	Arteriovenous pCO2 gap reduction	6, 12, 24, 48 and 72 hours after the randomization time
Secondary	Arterial blood lactate level reduction	Arterial blood lactate level reduction	6, 12, 24, 48 and 72 hours after the randomization time
Secondary	ICU length of stay	ICU length of stay	up to 3 months after the randomization date
Secondary	Hospital stay time	Hospital stay time	up to 3 months after the randomization date
Secondary	Mechanical ventilation time	Mechanical ventilation time	up to 3 months after the randomization date
Secondary	Continuous renal replacement therapy time	Continuous renal replacement therapy time	up to 3 months after the randomization date