Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial.
The goal of this clinical trial is the estimation of the efficacy and safety of hemoadsorption procedures (LPS (Lipopolysaccharide) and inflammatory mediators adsorption) in participants with septic shock.
The main questions it aims to answer are:
Does hemoadsorption decrease the severity of MODS (multiple organ disfunction syndrome)?
The study will include participants aged 18 to 80 years with a verified diagnosis of septic shock according to SEPSIS 3 criteria, diagnosed within 12 hours, and a SOFA (sequential organ failure assessment) score of 9 or more.
In addition to Standard of Care (SOC), blood purification, including hemoadsorption, will be used. The minimum waiting time after diagnosis of septic shock and initiation of basic therapy before inclusion of the patient in the study therapy is 4 hours.
The choice of procedure will be based on the EAA (Endotoxin Activity Assay) result:
* for an EAA level of 0.6-0.9, selective lipopolysaccharide (LPS) adsorption with duration from 2 to 10 hours; * for an EAA level less than 0.6, inflammatory mediator adsorption with duration from 6 to 12 hours.
The choice of a specific adsorbers within the LPS and inflammatory mediator adsorption group will be based on randomization.
The use of LPS adsorption is planned based on randomization: Toramyxin R-20 or Efferon LPS. The use of inflammatory mediator adsorption is planned based on randomization: Jafron (HA 330) or CytoSorb.
Septic shock according to SEPSIS-3 criteria
Age: 18-80 years
SOFA ≥9 points
Diagnosis of septic shock established <12 hours ago
Absolute neutrophil count less than 500 cells/μL
Pregnancy
End-stage heart failure (NYHA stage IV)
Pulmonary embolism with obstructive shock
Parallel
Efferon LPS
DeviceBlood purification with Efferon LPS
Toramyxin PMX 20R
DeviceBlood purification with Toramyxin PMX 20R
Jafron HA 330
DeviceBlood purification with Jafron HA 330
CytoSorb
DeviceBlood purification with Jafron HA 330
SOFA (sequential organ failure assessment) score
MODS (multiple organ disfunction syndrome) dynamics majored by SOFA (sequential organ failure assessment) score. SOFA score ranges from 0 (best) to 24 (worst) points.
Vasoactive Inotropic Score (VIS) dynamics
Vasoactive Inotropic Score (VIS) dynamics VIS = dopamine dose (mcg∕kg∕ min ) + dobutamine dose (mcg∕kg∕ min ) + 100 × epinephrine dose (mcg∕kg∕ min ) + 10 × milrinone dose (mcg∕kg∕ min ) + 10,000 × vasopressin dose (units∕kg∕ min ) \+ 100 × norepinephrine dose (mcg∕kg∕ min )
Norepinephrine dose dynamics
Norepinephrine dose dynamics (mcg/kg/min)
Hemodynamic index dynamics
Hemodynamic index: Mean arterial pressure (MAP) to Vasoactive Inotropic Score (VIS); VIS = dopamine dose (mcg∕kg∕ min ) + dobutamine dose (mcg∕kg∕ min ) + 100 × epinephrine dose (mcg∕kg∕ min ) + 10 × milrinone dose (mcg∕kg∕ min ) + 10,000 × vasopressin dose (units∕kg∕ min ) + 100 × norepinephrine dose (mcg∕kg∕ min )
Horowitz index dynamics
Arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2) ratio (Horowitz index) dynamics
Ventilator-free days
Ventilator-free days
Vasopressor-free days
Vasopressor-free days
Dialysis-free days
Dialysis-free days
Hospital length of stay
Hospital length of stay
Click on the lead sponsor to view all of their trials.
Moscow Multidisciplinary Clinical Center "Kommunarka"
Lead sponsor
Petrovsky National Research Centre of Surgery
Collaborator
Bakulev Scientific Center of Cardiovascular Surgery
Collaborator
City clinical hospital named after S. S. Yudin, Moscow City Health
Collaborator
Sklifosovsky Institute of Emergency Care
Collaborator
City Clinical Hospital No 52, Moscow, Russia
Collaborator
Rostov Regional Clinical Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
