Clinical trials

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.

The purpose of this multicenter, randomized controlled trial (ULTRASVENT-2) is to evaluate the effect of different positive end-expiratory pressure (PEEP) levels on postoperative oxygenation and lung aeration in adult patients undergoing elective non-cardiac and non-thoracic surgery under general anesthesia. Moving away from traditional binary outcomes, this study utilizes a continuous functional metric, the non-invasive oxygenation index SpO2/FiO2 (S/F ratio), as the primary endpoint to precisely capture the degree of respiratory function preservation. Patients will be stratified into four distinct surgical cohorts based on the type and aggressiveness of the procedure: non-abdominal surgery, major open abdominal surgery, major laparoscopic abdominal surgery, and low-trauma laparoscopic surgery. This adaptive design aims to investigate how protective PEEP strategies interact with varying degrees of surgical trauma and intraoperative pneumoperitoneum, allowing the optimization of mechanical ventilation parameters for routine clinical practice.