SPICE III (subgroup analysis)
Trial question
What is the effect of dexmedetomidine on vasopressor requirement in critically ill patients with septic shock?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 83
83 patients (26 female, 57 male).
Inclusion criteria: critically ill adult patients with septic shock receiving mechanical ventilation.
Key exclusion criteria: age < 18 years; pregnancy or lactation; intubation for > 12 hours in the ICU; acute primary brain lesion; spinal cord injury; admission as a consequence of drug overdose or burns; administration of ongoing neuromuscular blockade; acute fulminant hepatic failure; imminent death.
Interventions
N=44 dexmedetomidine (dexmedetomidine infusion as a sole or primary sedative).
N=39 usual care (standard care sedation, such as propofol, midazolam, or other sedatives).
Primary outcome
Median vasopressor requirement in first 48 hours
0.03
0.04
0.0 mcg/kg...
0.0 mcg/kg...
0.0 mcg/kg...
0.0 mcg/kg...
0.0 mcg/kg...
Dexmedetomidine
Usual
care
No significant
difference ↔
No significant difference in median vasopressor requirement in the first 48 hours (0.03 mcg/kg/min vs. 0.04 mcg/kg/min; MD -0.01, 95% CI -0.06 to 0.04).
Secondary outcomes
No significant difference in cumulative vasopressor dose (1.51 mcg/kg per 48 hours vs. 2.14 mcg/kg per 48 hours; MD -0.62, 95% CI -3.18 to 1.93).
No significant difference in peak vasopressor dose (0.12 mcg/kg/min vs. 0.16 mcg/kg/min; MD -0.03, 95% CI -0.12 to 0.06).
No significant difference in total duration of vasopressor support (51.6 hours vs. 45.7 hours; MD 3.1, 95% CI -30.7 to 36.9).
Safety outcomes
No significant difference in serious adverse events.
Significant difference in hypotension (15.9% vs. 2.6%).
Conclusion
In critically ill adult patients with septic shock receiving mechanical ventilation, dexmedetomidine was not superior to usual care with respect to median vasopressor requirement in the first 48 hours.
Reference
Luca Cioccari, Nora Luethi, Michael Bailey et al. The effect of dexmedetomidine on vasopressor requirements in patients with septic shock: a subgroup analysis of the Sedation Practice in Intensive Care Evaluation [SPICE III] Trial. Crit Care. 2020 Jul 16;24(1):441.
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