In this dose-finding, phase 2 adaptive randomized trial, patients with septic shock and moderate organ dysfunction were treated early in the course of illness with low (6 g), medium (12 g), or high (18 g) doses of levocarnitine or an equivalent volume of saline placebo administered as a 12-hour infusion. None of the tested doses of levocarnitine meaningfully reduced cumulative organ failure at 48 hours. This trial has several additional limitations to consider. We chose change in the SOFA scores as a surrogate outcome based on strong correlations between this measure and 28-day mortality. We screened 2694 individuals and enrolled 250 patients (mean [SD] age, 61.7 [14.8] years; 56.8% male). The most efficacious dose of levocarnitine (18 g) demonstrated 78% and 77% probabilities of superiority compared with placebo in the intent-to-treat (ITT) and per-protocol (PP) analyses, respectively.

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