Infusions of the beta-blocker landiolol did not significantly reduce organ failure in patients with septic shock and norepinephrine-treated tachycardia, compared with standard care, the STRESS-L trial shows. “This study was stopped after recruiting 126 of 340 patients because it was unlikely to demonstrate benefit should recruitment have continued and there was a signal of possible harm in the intervention group,” the investigators write.
Conducted in 40 U.K. National Health Service intensive care units from 2018 to 2021, adults with tachycardia and established septic shock treated for at least 24 hours with continuous norepinephrine were randomized to standard care or landiolol infusion. The primary outcome was the mean Sequential Organ Failure Assessment (SOFA) score from randomization through 14 days.
“The trial was stopped prematurely on the advice of the independent data monitoring committee because it was unlikely to demonstrate benefit and because of possible harm,” the authors write. “Of a planned 340 participants, 126 (37%) were enrolled (mean age, 55.6 years [95% CI, 52.7 to 58.5 years]; 58.7% male). The mean (SD) SOFA score in the landiolol group was 8.8 (3.9) compared with 8.1 (3.2) in the standard care group (mean difference [MD], 0.75 [95% CI, −0.49 to 2.0]; P = .24). Mortality at day 28 after randomization in the landiolol group was 37.1% (23 of 62) and 25.4% (16 of 63) in the standard care group (absolute difference, 11.7% [95% CI, −4.4% to 27.8%]; P = .16). Mortality at day 90 after randomization was 43.5% (27 of 62) in the landiolol group and 28.6% (18 of 63) in the standard care group (absolute difference, 15% [95% CI, −1.7% to 31.6%]; P = .08). There were no differences in the number of patients having at least one adverse event.”