DESIRE
Trial question
What is the effect of dexmedetomidine in patients with sepsis requiring mechanical ventilation?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 201
201 patients (74 female, 127 male).
Inclusion criteria: adult patients with sepsis requiring mechanical ventilation for at least 24 hours.
Key exclusion criteria: severe chronic liver disease; acute MI or severe HF; drug dependence, alcohol use disorder, or a psychological illness or severe cognitive dysfunction; pregnancy or lactation; hypersensitivity to dexmedetomidine.
Interventions
N=100 dexmedetomidine (continuous dexmedetomidine and analgesia, and other sedatives added as needed).
N=101 no dexmedetomidine (sedative drugs such as propofol, midazolam, and analgesia without dexmedetomidine).
Primary outcome
Death at 28 days
22.8%
30.8%
30.8 %
23.1 %
15.4 %
7.7 %
0.0 %
Dexmedetomidine
No
dexmedetomidine
No significant
difference ↔
No significant difference in death at 28 days (22.8% vs. 30.8%; HR 0.69, 95% CI 0.38 to 1.22).
Secondary outcomes
No significant difference in ventilator-free days within 28 days (20 days vs. 18 days; AD 2 days, 95% CI -1.05 to 5.05).
No significant difference in ICU length of stay (7 days vs. 8 days; AD -1 days, 95% CI -3.44 to 1.44).
Borderline significant increase in ventilator days (6 days vs. 6 days).
Safety outcomes
No significant difference in bradycardia and acute coronary syndrome.
Significant difference in CRP levels (4.9 mg/dL vs. 8.1 mg/dL).
Conclusion
In adult patients with sepsis requiring mechanical ventilation for at least 24 hours, dexmedetomidine was not superior to no dexmedetomidine with respect to death at 28 days.
Reference
Yu Kawazoe, Kyohei Miyamoto, Takeshi Morimoto et al. Effect of Dexmedetomidine on Mortality and Ventilator-Free Days in Patients Requiring Mechanical Ventilation With Sepsis: A Randomized Clinical Trial. JAMA. 2017 Apr 4;317(13):1321-1328.
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