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

Burdenko Neurosurgery Institute

Status: Unknown

Conditions: Septic Shock

Treatments: Procedure: CRRT; Procedure: Combined extracorporeal blood purification

Study type: Interventional

Funder types: Other

Identifiers

NCT04152174

PPI-2018-06-5

Details and patient eligibility

About

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).

Full 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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14 participants in 2 patient groups

Combined extracorporeal blood purification

Experimental group

Description:

CRRT with CVVHDF mode plus treatment with CytSorb adsorber

Treatment:

Procedure: Combined extracorporeal blood purification

Control

Active Comparator group

Description:

CRRT with CVVHDF mode

Treatment:

Procedure: CRRT