Time points | Study period | ||||
---|---|---|---|---|---|
Enrollment | Post-enrollment | ||||
Day 1 | Days 2–30 | ICU/hosp discharge | Month 6 | Month 9 | |
Enrolment | |||||
Eligibility screen | x | ||||
Informed consent | x | ||||
Treatment allocation | x | ||||
Intervention | |||||
Midodrine or placebo | x | ||||
Assessments | |||||
Age, sex | x | ||||
Weight and height | x | ||||
Date of eligibility | x | ||||
ICU and hospital admission date | x | ||||
ICU admission type | x | ||||
ICU admission diagnosis | x | ||||
Clinical frailty scale score | x | ||||
APACHE II score | x | ||||
Etiology of shock | x | ||||
Comorbid illness | x | ||||
Vasopressor therapy | x | x | |||
Mechanical ventilation | x | x | |||
Total duration of vasopressor support | x | ||||
Vasopressors initiated after cessation | x | ||||
ICU or hospital death | x | ||||
Date of ICU death or discharge | x | ||||
ICU length of stay | x | ||||
Hospital length of stay | x | ||||
ICU readmission during hospital stay | x | ||||
Discharge location from hospital | x | ||||
Persistent organ dysfunction or death | x | x | |||
EQ-5D | x | ||||
Adverse events | x | x | x | x | x |
Cardiac events (clinically significant bradycardia, acute coronary syndrome) | x | x | x | x | x |
Allergic events (paresthesia, piloerection, dysuria, pruritis, chills, pain, rash) | x | x | x | x | x |
Hypertension | x | x | x | x | x |
Bowel ischemia | x | x | x | x | x |
Limb ischemia | x | x | x | x | x |
Stroke | x | x | x | x | x |
Protocol violations | x | x | x | x | x |