CHEETAH
Trial question
What is the effect of levosimendan in patients who required perioperative hemodynamic support after cardiac surgery?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 506
506 patients (179 female, 327 male).
Inclusion criteria: patients requiring perioperative hemodynamic support after cardiac surgery.
Key exclusion criteria: previous adverse response to levosimendan; receipt of levosimendan in the previous 30 days; receipt of a kidney or liver transplant; liver cirrhosis; receipt of ECMO; DNR order.
Interventions
N=248 levosimendan (continuous infusion at a dose of 0.025-0.2 mcg/kg/min plus standard care).
N=258 placebo (infusion of a mixed-vitamins solution with a yellow color, devoid of relevant cardiovascular effects, plus standard care).
Primary outcome
Death at day 30
12.9%
12.8%
12.9 %
9.7 %
6.5 %
3.2 %
0.0 %
Levosimendan
Placebo
No significant
difference ↔
No significant difference in death at day 30 (12.9% vs. 12.8%; AD 0.1%, 95% CI -5.7 to 5.9).
Secondary outcomes
No significant difference in duration of mechanical ventilation (19 hours vs. 21 hours; AD -2 hours, 95% CI -5 to 1).
No significant difference in length of ICU stay (72 hours vs. 84 hours; AD -12 hours, 95% CI -21 to 2).
No significant difference in length of hospital stay (14 days vs. 14 days).
Safety outcomes
No significant differences in serious adverse events, hypotension, and cardiac arrhythmias.
Conclusion
In patients requiring perioperative hemodynamic support after cardiac surgery, levosimendan was not superior to placebo with respect to death at day 30.
Reference
Giovanni Landoni, Vladimir V Lomivorotov, Gabriele Alvaro et al. Levosimendan for Hemodynamic Support after Cardiac Surgery. N Engl J Med. 2017 May 25;376(21):2021-2031.
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