Effect of a personalized hemodynamic optimization strategy during septic shock: a stepped-wedge, cluster-randomized, open-label, controlled trial

Purpose Treatment of circulatory failure involves fluid and/or catecholamines infusion. Excessive fluid infusion is associated with worse outcomes, while restrictive fluid strategies show no significant benefits. We aimed to evaluate efficacy of a personalized hemodynamic optimization protocol including three pillars: (i) diagnosing acute circulatory failure, (ii) using a validated hemodynamic monitoring, and (iii) evaluating preload dependency state before any fluid resuscitation. Methods Multicenter, stepped-wedge, cluster-randomized trial involving adult patients with septic shock due to an abdominal or a pulmonary infection. Patients received either usual care (control period), or a personalized hemodynamic optimization strategy (intervention period). Hierarchized primary outcomes included delta SOFA (Sepsis-related Organ Failure Assessment) score from inclusion to day 5, ICU length of stay, hospital length of stay, ventilator-free days, renal failure-free days and catecholamine-free days. Results 517 patients were enrolled: 289 in the control group and 228 in the intervention group. Delta SOFA score was 2.4 in the control group and 1.8 in the intervention group (p = 0.41). ICU length of stay was reduced by 2.5 days (95% CI 0 to 5) in the intervention group. In overall population, other primary outcomes showed no differences. For severe patients (i.e., baseline SOFA ≥ 10), ICU and hospital stay length of stay was also reduced by 3.7 days (95% CI -0.4 to 7.8) and 6.9 days (95% CI -0.7 to 14.4), respectively. Conclusion Although no statistically significant difference was observed in delta SOFA score, a personalized hemodynamic optimization strategy reduced ICU length of stay. Trial Registration ClinicalTrials.gov Identifier NCT03461900