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Table 2 Trial activity timeline

From: LIBERATE: a study protocol for midodrine for the early liberation from vasopressor support in the intensive care unit (LIBERATE): protocol for a randomized controlled trial

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