Nishikimi
Trial question
What is the effect of ramelteon in critically ill patients in the ICU?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 88
88 patients (31 female, 57 male).
Inclusion criteria: patients in the ICU who could take medicines PO or through a nasogastric tube during the first 48 hours of admission.
Key exclusion criteria: already in receipt of ramelteon or fluvoxamine maleate prior to the admission, known allergy to ramelteon, refusal to provide consent for participation in the study.
Interventions
N=45 ramelteon (8 mg/day at 20:00 hours every day until discharge from the ICU).
N=43 placebo (1 g/day of lactose powder at 20:00 hours every day until discharge from the ICU).
Primary outcome
Duration of intensive care unit stay
4.56 days
5.86 days
5.9 days
4.4 days
2.9 days
1.5 days
0.0 days
Ramelteon
Placebo
Significant
decrease ▼
Significant decrease in duration of ICU stay (4.56 days vs. 5.86 days; AD -1.3 days, 95% CI -2.46 to -0.14).
Secondary outcomes
Significant increase in occurrence rate of delirium (24.4% vs. 46.5%; OR 2.69, 95% CI 1.09 to 6.65).
Significant decrease in duration of delirium (0.78 days vs. 1.4 days; AD -0.62 days, 95% CI -1.24 to 0).
No significant difference in death at discharge (6.7% vs. 7.5%; RR 0.89, 95% CI -1273.77 to 1275.55).
Safety outcomes
No significant difference in mean hours of sleep.
Significant differences in awakenings per night (0.80 times per night vs. 1.31 times per night), nights without awakenings (51% vs. 30%).
Conclusion
In patients in the ICU who could take medicines PO or through a nasogastric tube during the first 48 hours of admission, ramelteon was superior to placebo with respect to duration of ICU stay.
Reference
Mitsuaki Nishikimi, Atsushi Numaguchi, Kunihiko Takahashi et al. Effect of Administration of Ramelteon, a Melatonin Receptor Agonist, on the Duration of Stay in the ICU: A Single-Center Randomized Placebo-Controlled Trial. Crit Care Med. 2018 Jul;46(7):1099-1105.
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