The investigators aim to perform a randomized, double-blind, placebo-controlled trial to investigate the efficacy of midodrine in decreasing time to IV vasopressor liberation in patients with septic shock.
A growing body of literature comprising largely retrospective data seems to support the safety and efficacy of midodrine in the intensive care unit for decreasing IV vasopressor use. The investigators hypothesize that administration of midodrine in the early phase of septic shock in patients with adequate enteral access will result in a significant decrease in time to IV vasopressor liberation (increase in vasopressor-free days), secondarily resulting in decreased central venous catheter dwell times and intensive care unit length of stay.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
10
Midodrine Hydrochloride, enteral, 10 or 20 mg
investigational pharmacy formulated placebo comparator
University of Virginia
Charlottesville, Virginia, United States
Days Free of Vasopressors (Days)
days without vasopressor adjusted with mortality
Time frame: 90 days from enrollment
Central Venous Catheter Free Days
Time frame: 90 days from enrollment
Intensive Care Unit Length of Stay (ICU LOS; Days)
Time frame: 90 days from enrollment
Hospital Length of Stay (Hospital LOS; Days)
Time frame: 90 days from enrollment
30-day Mortality
Time frame: 30 days from enrollment
90-day Mortality
Time frame: 90 days from enrollment
In-hospital Mortality
Mortality during sentinel admission
Time frame: From randomization until date of death if occurred prior to discharge from sentinel hospitalization, assessed up to 52 weeks
Intensive Care Unit Mortality
Mortality during intensive care unit stay during sentinel admission
Time frame: From randomization until date of death if occurred prior to discharge from the sentinel intensive care unit admission, assessed up to 52 weeks
Need to Re-initiate IV Vasopressors 2 or More Hours After Discontinuation
Time frame: From randomization until date of discharge from the sentinel intensive care unit admission, assessed up to 52 weeks
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