Jean-Pierre Quenot1,2,3, Christine Binquet4,5, Christophe Vinsonneau6, Saber-David Barbar7, Sandrine Vinault4,5, Valerie Deckert8,9, Stéphanie Lemaire8,9, Ali Ait Hassain10, Rémi Bruyère11, Bertrand Souweine10, Laurent Lagrost8,9, Christophe Adrie6,12. 1. Intensive Care Unit, University Hospital of Dijon, Dijon, France. jean-pierre.quenot@chu-dijon.fr. 2. Clinical Epidemiology Unit, INSERM, CIC1432, Dijon, France. jean-pierre.quenot@chu-dijon.fr. 3. Lipness Team, INSERM, Research Center UMR866 and LabEx LipSTIC, Université de Bourgogne, Dijon, France. jean-pierre.quenot@chu-dijon.fr. 4. Clinical Epidemiology Unit, INSERM, CIC1432, Dijon, France. 5. Clinical Epidemiology/Clinical Trials Unit, Clinical Investigation Centre, Dijon University Hospital, Dijon, France. 6. Intensive Care Unit, Hospital of Melun, Melun, France. 7. Intensive Care Unit, University of Nimes, Nimes, France. 8. Lipness Team, INSERM, Research Center UMR866 and LabEx LipSTIC, Université de Bourgogne, Dijon, France. 9. Clinical Research Department, University Hospital of Dijon, Dijon, France. 10. Intensive Care Unit, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France. 11. Intensive Care Unit, University Hospital of Dijon, Dijon, France. 12. Physiology Department, Cochin Hospital, Paris, France.
Abstract
PURPOSE: We compared hemodynamic and biological effects of the Cascade system, which uses very high volume hemofiltration (HVHF) (120 mL kg(-1) h(-1)), with those of usual care in patients with septic shock. METHODS: Multicenter, prospective, randomized, open-label trial in three intensive care units (ICU). Adults with septic shock with administration ofepinephrine/norepinephrine were eligible. Patients were randomized to usual care plus HVHF (Cascade group), or usual care alone (control group). Primary end point was the number of catecholamine-free days up to 28 days after randomization. Secondary end points were number of days free of mechanical ventilation, renal replacement therapy (RRT) or ICU up to 90 days, and 7-, 28-, and 90-day mortality. RESULTS: We included 60 patients (29 Cascade, 31 usual care). Baseline characteristics were comparable. Median number of catecholamine-free days was 22 [IQR 11-23] vs 20 [0-25] for Cascade vs control; there was no significant difference even after adjustment. There was no significant difference in number of mechanical ventilation-free days or ICU requirement. Median number of RRT-free days was 85 [46-90] vs 74 [0-90] for Cascade vs control groups, p = 0.42. By multivariate analysis, the number of RRT-free days was significantly higher in the Cascade group (up to 25 days higher after adjustment). There was no difference in mortality at 7, 28, or 90 days. CONCLUSION: Very HVHF using the Cascade system can safely be used in patients presenting with septic shock, but it was not associated with a reduction in the need for catecholamines during the first 28 days.
RCT Entities:
PURPOSE: We compared hemodynamic and biological effects of the Cascade system, which uses very high volume hemofiltration (HVHF) (120 mL kg(-1) h(-1)), with those of usual care in patients with septic shock. METHODS: Multicenter, prospective, randomized, open-label trial in three intensive care units (ICU). Adults with septic shock with administration of epinephrine/norepinephrine were eligible. Patients were randomized to usual care plus HVHF (Cascade group), or usual care alone (control group). Primary end point was the number of catecholamine-free days up to 28 days after randomization. Secondary end points were number of days free of mechanical ventilation, renal replacement therapy (RRT) or ICU up to 90 days, and 7-, 28-, and 90-day mortality. RESULTS: We included 60 patients (29 Cascade, 31 usual care). Baseline characteristics were comparable. Median number of catecholamine-free days was 22 [IQR 11-23] vs 20 [0-25] for Cascade vs control; there was no significant difference even after adjustment. There was no significant difference in number of mechanical ventilation-free days or ICU requirement. Median number of RRT-free days was 85 [46-90] vs 74 [0-90] for Cascade vs control groups, p = 0.42. By multivariate analysis, the number of RRT-free days was significantly higher in the Cascade group (up to 25 days higher after adjustment). There was no difference in mortality at 7, 28, or 90 days. CONCLUSION: Very HVHF using the Cascade system can safely be used in patients presenting with septic shock, but it was not associated with a reduction in the need for catecholamines during the first 28 days.
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