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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-10

Study Completion Date

2021-11-10

Brief Summary

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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).

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Detailed Description

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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

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Combined extracorporeal blood purification

CRRT with CVVHDF mode plus treatment with CytSorb adsorber

Group Type EXPERIMENTAL

Combined extracorporeal blood purification

Intervention Type PROCEDURE

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

Control

CRRT with CVVHDF mode

Group Type ACTIVE_COMPARATOR

CRRT

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

CRRT

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

Intervention Type PROCEDURE

Eligibility Criteria

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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