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Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation

Study acronym: HAdSS
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary endpoint(s) modifiedv2 Show 6 more changesShow less
    • Primary completion date: Jun 20, 2027 to Jun 25, 2027
    • Study completion date: Dec 20, 2027 to Dec 25, 2027
    • Start date: Jun 20, 2026 to Jun 25, 2026
    • Secondary endpoints revised (20)
    • Study description expanded, about 240 words
    • Study title revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07661303
Lead Sponsor Moscow Multidisciplinary Clinical Center "Kommunarka"
Collaborators: Petrovsky National Research Centre of Surgery, Bakulev Scientific Center of Cardiovascular Surgery, City clinical hospital named after S. S. Yudin, Moscow City Health, Sklifosovsky Institute of Emergency Care, City Clinical Hospital No 52, Moscow, Russia, Rostov Regional Clinical Hospital
Conditions
(from sponsor)		 Septic Shock
Related terms Endotoxemia, Multiple Organ Failure, Shock, Septic
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov