Adjunctive terlipressin versus placebo in the treatment of refractory septic shock: a randomized, placebo-controlled trial
Abstract
Terlipressin’s role as an adjunctive vasopressor in septic shock remains controversial. We aimed to evaluate the efficacy of terlipressin versus placebo as an additional vasopressor in refractory septic shock. We conducted a single-center, prospective, double-blind, randomized controlled trial in a medical intensive care unit. Adult patients with septic shock requiring norepinephrine > 0.2 mcg/kg/min or epinephrine were randomly assigned (1:1) to receive terlipressin or placebo. The primary outcome was the proportion of patients achieving mean arterial pressure ≥ 65 mmHg with total catecholamine equivalent dose below 0.2 mcg/kg/min at 6 h after randomization. A total of 130 patients were enrolled: 66 in the terlipressin group and 64 in the placebo group. Baseline characteristics were comparable. The median (interquartile range) baseline norepinephrine equivalent dose was 0.39 (0.29 − 0.73) mcg/kg/min for terlipressin versus 0.39 (0.27 − 0.62) mcg/kg/min for placebo. Pneumonia (57.6% vs 48.4%) and intra-abdominal infection (21.2% vs 23.4%) were the most common etiologies in the terlipressin and placebo arms, respectively. Significantly more patients met the primary outcome with terlipressin than with placebo (22.7% vs 9.4%; relative risk [RR] = 1.53, 95% confidence interval [CI] = 1.09–2.14; P = 0.039). The 28-day mortality was 60.6% in the terlipressin group versus 64.1% in the placebo group (RR = 0.93, 95% CI = 0.66–1.31; P = 0.68). Digital ischemia occurred in 28.8% versus…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 130 participants or records.
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