Sepsis & infection

Landiolol and Organ Failure in Patients With Septic Shock: The STRESS-L Randomized Clinical Trial

JAMAPublished Randomised controlled trial

Primary resultResult — go to the resultMD 0.75 95% CI −0.49 to 2.0
  • early termination
  • Stopped prematurely on advice of the independent data monitoring committee: unlikely to demonstrate benefit and possible harm

Authors' conclusion

Among patients with septic shock with tachycardia and treated with norepinephrine for more than 24 hours, an infusion of landiolol did not reduce organ failure measured by the SOFA score over 14 days from randomization.

Study context

Population
Adults with tachycardia (heart rate ≥95/min) and established septic shock treated ≥24 hours with norepinephrine (≥0.1 μg/kg/min), 40 UK NHS ICUs37% of planned 340
Participants
126 adults
Comparison
Landiolol infusion vs standard care
  • Landiololn = 63
  • Standard caren = 63reference
Primary endpoint
Mean Sequential Organ Failure Assessment (SOFA) score from randomisation through 14 days
Follow-up
14 days
Methodological detailsopen-label, multicentre
  • Open-label
  • Multicentre

Primary result

As reported in the abstract

MD

0.75

95% CI −0.49 to 2.0

P = 0.24

By group

Landiolol

8.8

mean · SD 3.9

Standard care

8.1

mean · SD 3.2

Landiolol vs Standard care
MD 0.75 (95% CI −0.49 to 2.0); P = 0.24

Secondary outcomes

OutcomeLandiololStandard careAbsolute difference (95% CI)P value
Mortality · day 2837.1%25.4%11.7% (−4.4% to 27.8%)P = 0.16
Mortality · day 9043.5%28.6%15% (−1.7% to 31.6%)P = 0.08
  • Mortality: 23 of 62 vs 16 of 63
  • Mortality: 27 of 62 vs 18 of 63

Safety

Patients with at least one adverse event

No differences between groups

Original publication

Landiolol and Organ Failure in Patients With Septic Shock: The STRESS-L Randomized Clinical Trial. JAMA. Published 7 November 2023. doi:10.1001/jama.2023.20134

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