An interventional study of Efferon LPS hemoperfusion in Septic Shock, sponsored by Efferon JSC. Completed at 4 sites in Russia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Efferon JSC · Not applicable, Interventional, and Treatment
Sepsis is a global healthcare burden sepsis, it reaches 20-30 million cases annually (WHO data). Numerous studies have shown that extracorporeal hemoperfusion therapies that eliminate endotoxin and\or excess of cytokines improve treatment outcomes in patients with septic shock. The main purpose of the study is to obtain new data on the efficacy and safety of the Efferon LPS device in extracorporeal therapy in patients with abdominal sepsis complicated by septic shock.
Sepsis is a global healthcare burden sepsis, it reaches 20-30 million cases annually (WHO data). A two-stage trial by Rudnov et al. using one-day data from 62 centres in 29 subjects of the Russian Federation showed that one third of the patients admitted to the ICU were patients with infection, one fifth of them developed septic shock, the proportion of hospital sepsis was 46.6%, and fatal outcome occurred in 30.4% of patients with infection. Despite apparent advances in intensive care, the prognosis of patients with endotoxaemia and septic shock remains poor.
Extracorporeal removal of toxic substances from the bloodstream by adsorbing them onto a porous material may provide clear clinical benefits. Extracorporeal blood adsorption method can be a good complement or substitute for the classical methods of haemofiltration and haemodialysis if the diffusion or convection of toxic substances through the membrane is not efficient enough. Since the method was first proposed by Muirhead and Reid in 1948, it has developed considerably.
Endotoxin (lipopolysaccharide), one of the most potent mediators of sepsis, is found in high concentrations in about 50% of patients with septic shock. The use of extracorporeal sorption techniques that eliminate endotoxin has been shown in numerous trials to improve outcomes in patients with septic shock.
Efferon LPS (Efferon JSC, Moscow, Russia) is a single-use therapeutic device for extracorporeal blood purification using direct hemoperfusion. Detoxification is carried out by selective adsorption of lipopolysaccharides (bacterial endotoxins) and non-selective removal of cytokines by internal porous structure. It is a cylindrical polycarbonate casing filled with spherical granules of LPS-selective polymeric adsorbent mesoporous beads and isotonic sodium chloride solution. The device is registered in Russia as a medical device RZN 2019/8886.
890 studies on the registry are indexed under Shock, Septic; 210 are open to participants now.
This study's enrollment of 58 is below the median of 78 across 547 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Efferon JSC is the lead sponsor of 20 studies on the registry; 6 are open to participants now.
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Hypotension requiring vasopressor support: the need for at least one of the vasopressors listed below at the dose listed below for at least 2 hours continuously and not more than 12 hours.
Exclusion Criteria:
Lack of adequate antimicrobial chemotherapy
Basic therapy is the institution's routine practice for treating patients with septic shock against a background of abdominal sepsis plus extracorporeal hemoperfusion therapy (Efferon LPS)
Device: Efferon LPS hemoperfusion
Basic therapy is the institution's routine practice for treating patients with septic shock against a background of abdominal sepsis.
Hemoperfusion using continuous extracorporeal LPS adsorption with Efferon LPS therapeutic device during a period of 24h immediately following admission to the intensive care unit
Also known as: extracorporeal blood adsorption
Effect of the Efferon LPS hemoperfusion in extracorporeal therapy in patients with abdominal sepsis complicated by septic shock
The time (number of days) from randomisation to the earliest time that the 'resolution of septic shock' event is achieved. Event criteria: 1) end of vasopressor support (persistence of effect - for 4 hours) and 2) investigator/trained staff rating the trial as 'resolved' when assessed from baseline to day 14 or hospital discharge (if discharge occurs earlier than day 14).
Time frame: 1-14 days
Effect of the Efferon LPS hemoperfusion on systemic haemodynamic parameters after the start of use in patients with abdominal sepsis complicated by septic shock
Sats every 6 hours ± 1 hour from the start of hemoperfusion (hour 0) to 72 hours. The time (number of days) from randomisation to the end of vasopressor support within 72 x hours or hospital discharge (if earlier than 72 hours). Maximum dose of vasopressors within 24 hours and 72 hours of the start of hemoperfusion.
Time frame: 1-72 hours
Effect of the Efferon LPS hemoperfusion on pulmonary oxygen metabolism function in patients with abdominal sepsis complicated by septic shock
Value of oxygenation index (Pa02 / Fi02 (Pa) every 24 hours ± 1 hour from the start of hemoperfusion (hour 0) to 72 hours
Time frame: 1-72 hours
Effect of the Efferon LPS hemoperfusion on the length of stay in the ICU of patients with abdominal sepsis complicated by septic shock
The time (number of days) from randomisation to transfer from the ORIT within 14 days or hospital discharge or transfer from the ORIT (if occurring earlier than day 14).
Time frame: 1-14 days
Plan to share: No
Ran from Mar 2021 to primary completion in Mar 2022, 12 months.
Of 150 interventional studies with no phase under Shock, Septic, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's 12 months is below that.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Efferon JSC