MIDAS
Trial question
What is the role of midodrine on time to vasopressor discontinuation in patients with persistent hypotension in the ICU?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
48.0% female
52.0% male
N = 132
132 patients (64 female, 68 male).
Inclusion criteria: adult patients with hypotension requiring a single-agent intravenous vasopressor for ≥ 24 hours.
Key exclusion criteria: clinical evidence of inadequate tissue oxygenation, hypovolemic shock or hypotension due to adrenal insufficiency, liver failure, chronic renal failure, severe organic heart disease, acute urinary retention, pheochromocytoma, thyrotoxicosis, bradycardia.
Interventions
N=66 midodrine (20 mg PO every 8 hours plus standard care).
N=66 placebo (matching placebo every 8 hours plus standard care).
Primary outcome
Median time to discontinuation of vasopressors
23.5 hours
22.5 hours
23.5 hours
17.6 hours
11.8 hours
5.9 hours
0.0 hours
Midodrine
Placebo
No significant
difference ↔
No significant difference in median time to discontinuation of vasopressors (23.5 hours vs. 22.5 hours; AD 1 hours, 95% CI -10.4 to 12.3).
Secondary outcomes
No significant difference in median time to ICU discharge readiness (5 days vs. 5 days).
No significant difference in median ICU length of stay (6 days vs. 6 days).
No significant difference in median hospital length of stay (11 days vs. 14 days; AD -3 days, 95% CI -6.3 to 0.3).
Safety outcomes
No significant difference in adverse event rates.
Significant difference in bradycardia (7.6% vs. 0%).
Conclusion
In adult patients with hypotension requiring a single-agent intravenous vasopressor for ≥ 24 hours, midodrine was not superior to placebo with respect to median time to discontinuation of vasopressors.
Reference
Peter Santer, Matthew H Anstey, Maria D Patrocínio et al. Effect of midodrine versus placebo on time to vasopressor discontinuation in patients with persistent hypotension in the intensive care unit (MIDAS): an international randomised clinical trial. Intensive Care Med. 2020 Oct;46(10):1884-1893.
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