LANDI-SEP
Trial question
What is the role of landiolol in patients with septic shock and persistent tachycardia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 196
196 patients (78 female, 118 male).
Inclusion criteria: adult patients with septic shock and persistent tachycardia.
Key exclusion criteria: compensatory tachycardia; age < 18 years.
Interventions
N=98 landiolol (a starting dose of 1 mcg/kg/min, with a maximum dose of 40 mcg/kg/min, target HR 80-94 bpm).
N=98 standard of care (standard treatment according to Surviving Sepsis Campaign guidelines, not targeted to HR control).
Primary outcome
Heart rate response and maintenance without increasing vasopressor requirements during first 24 hours after treatment initiation
39.8%
23.5%
39.8 %
29.8 %
19.9 %
9.9 %
0.0 %
Landiolol
Standard of
care
Significant
increase ▲
NNT = 6
Significant increase in HR response and maintenance without increasing vasopressor requirements during the first 24 hours after treatment initiation (39.8% vs. 23.5%; AD 16.5%, 95% CI 3.4 to 28.8).
Secondary outcomes
No significant difference in death at day 28 (43.9% vs. 40.2%; MD 3.8, 95% CI -9.9 to 17.3).
No significant difference in death in the ICU (43.9% vs. 34%; MD 9.9, 95% CI -3.8 to 23).
No significant difference in median duration of ICU stay for patients alive on day 28 (14 days vs. 13.9 days; HR 1.17, 95% CI 0.7 to 1.94).
Safety outcomes
No significant differences in adverse events, serious adverse events, new-onset arrhythmias.
Conclusion
In adult patients with septic shock and persistent tachycardia, landiolol was superior to standard of care with respect to HR response and maintenance without increasing vasopressor requirements during the first 24 hours after treatment initiation.
Reference
Sebastian Rehberg, Sandra Frank, Vladimír Černý et al. Landiolol for heart rate control in patients with septic shock and persistent tachycardia. A multicenter randomized clinical trial (Landi-SEP). Intensive Care Med. 2024 Oct;50(10):1622-1634.
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