1. Effects of enhanced adsorption haemofiltration versus haemoadsorption in severe, refractory septic shock with high levels of endotoxemia: the ENDoX bicentric, randomized, controlled trial.
- Author
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Wendel-Garcia, Pedro David, Eberle, Barbara, Kleinert, Eva-Maria, Hilty, Matthias Peter, Blumenthal, Stephan, Spanaus, Katharina, Fodor, Patricia, and Maggiorini, Marco
- Subjects
SEPTIC shock treatment ,TREATMENT of endotoxemia ,INTENSIVE care units ,RESEARCH ,VASOCONSTRICTORS ,CYTOKINES ,C-reactive protein ,LENGTH of stay in hospitals ,KRUSKAL-Wallis Test ,INTERLEUKINS ,BIOMARKERS ,FLUID therapy ,ENDOTOXINS ,HEMOPERFUSION ,INFLAMMATION ,NORADRENALINE ,BLOOD collection ,CALCITONIN ,SEVERITY of illness index ,TREATMENT effectiveness ,RANDOMIZED controlled trials ,ADSORPTION (Chemistry) ,DESCRIPTIVE statistics ,GLASGOW Coma Scale ,LACTATES ,CHI-squared test ,RESEARCH funding ,STATISTICAL sampling ,DATA analysis software ,POLYMYXIN B ,BLOOD filtration ,SEPTIC shock - Abstract
Background: Endotoxin adsorption is a promising but controversial therapy in severe, refractory septic shock and conflicting results exist on the effective capacity of available devices to reduce circulating endotoxin and inflammatory cytokine levels. Methods: Multiarm, randomized, controlled trial in two Swiss intensive care units, with a 1:1:1 randomization of patients suffering severe, refractory septic shock with high levels of endotoxemia, defined as an endotoxin activity ≥ 0.6, a vasopressor dependency index ≥ 3, volume resuscitation of at least 30 ml/kg/24 h and at least single organ failure, to a haemoadsorption (Toraymyxin), an enhanced adsorption haemofiltration (oXiris) or a control intervention. Primary endpoint was the difference in endotoxin activity at 72-h post-intervention to baseline. In addition, inflammatory cytokine, vasopressor dependency index and SOFA-Score dynamics over the initial 72 h were assessed inter alia. Results: In the 30, out of 437 screened, randomized patients (10 Standard of care, 10 oXiris, 10 Toraymyxin), endotoxin reduction at 72-h post-intervention-start did not differ among interventions (Standard of Care: 12 [1–42]%, oXiris: 21 [10–51]%, Toraymyxin: 23 [10–36]%, p = 0.82). Furthermore, no difference between groups could be observed neither for reduction of inflammatory cytokine levels (p = 0.58), nor for vasopressor weaning (p = 0.95) or reversal of organ injury (p = 0.22). Conclusions: In a highly endotoxemic, severe, refractory septic shock population neither the Toraymyxin adsorber nor the oXiris membrane could show a reduction in circulating endotoxin or cytokine levels over standard of care. Trial registration ClinicalTrials.gov. NCT01948778. Registered August 30, 2013. https://clinicaltrials.gov/study/NCT01948778 [ABSTRACT FROM AUTHOR]
- Published
- 2023
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