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Table 1 Schedule of events

From: The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) Protocol: a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial

Events

Screen enroll (time of randomization)

Day 1

Day 2

Day 3

Day 4

Day 5

ICU

D/C

Hospital

D/C

Day 30

Day 180

Procedure

 Eligibility Verification

X

         

 Informed consent

X

         

 Randomization

X

         

 Study drug admina

X

X

X

X

X

X

    

 Demographics

X

         

 Anthropometrics

X

         

 Source of Admission

X

         

 History and physicalb (including comorbidity)

X

         

 Respiratory supportb

X

X

X

X

X

X

X

X

O

 

 Vasopressor use (each agent and dose)b,c

X

X

X

X

X

X

X

X

O

 

 APACHE IId [71]

X

         

 SOFA scored [72]

X

X

X

X

X

X

    

 Vitalse

X

X

X

X

X

X

    

 GCS [90]

X

X

X

X

X

X

    

 RASS [73]

X

X

X

X

X

X

    

 CAM-ICUf [74, 75]

X

X

X

X

X

X

    

 Hematology (platelets)

A

A

A

A

A

A

    

 Chemistry (T. bili, creatinine)

A

A

A

A

A

A

    

 Lactate

A

A

A

       

 Coagulation

A

         

 Pregnancy testg

X

         

 Central research labsh

X

X

X

X

X

     

 Antimicrobial therapyb

X

     

X

X

O

 

 Infection source datab

X

     

X

X

  

 Health-care location

X

X

X

X

X

X

X

X

O

C

Adverse event monitoring

 Potentially associated

X

X

X

X

X

X

X

X

O

 

 Serious

X

X

X

X

X

X

X

X

O

 

Subject completion and follow-up

 Vital status

      

X

X

O

C

 Renal Replacement free days

       

X

O

 

 VVFD

       

X

O

 

 Neuro-psychological Battery [65]

         

C

  1. X = Performed by study site
  2. A = Collect if available
  3. O = Performed by study site only if patient remains hospitalized at 30 days
  4. C = Performed by Central Long-Term Outcomes Team
  5. aNote: patients who receive not more than three administrations of study drug/placebo on calendar day 1 will complete the last dose(s) on calendar day 5 (if they remain in the intensive care unit (ICU) that long)
  6. bWill be abstracted from electronic medical record (EMR). Abstracted data will include baseline data and daily data. For baseline data, use data from as close to the time of randomization as is possible. For daily values, use data from as close to 8 a.m. as is possible up to day 5 or ICU discharge (whichever occurs first). Vasopresssor doses will be recorded only at time of randomization
  7. cAfter day 5 or ICU discharge (whichever occurs first), report only the use of vasopressors or not (yes/no)
  8. dData elements collected via Research Electronic Data Capture (REDCap), score calculated centrally. For baseline Acute Physiology and Chronic Health Evaluation II (APACHE II), use most aberrant elements from the 24 h preceding the time of randomization. For baseline Sequential Organ Failure Assessment (SOFA) score, use data elements as close as possible to and preceding the time of randomization. For daily SOFA scores, use data elements from as close to 8 a.m. as is possible up to day 5 or ICU discharge (whichever occurs first)
  9. eMean arterial pressure, heart rate, respiratory rate, and temperature will be abstracted from EMR. Abstracted data will include baseline data and daily data. For baseline data, use data from as close to the time of randomization as is possible. For daily values, use data from as close to 8 a.m. as is possible up to day 5 of ICU discharge (whichever occurs first)
  10. fPerformed by research staff, at time of randomization and days 1–5 or ICU discharge (whichever occurs first)
  11. gPregnancy test (serum or urine), documentation of surgical sterilization, or menopausal required for eligibility. If not performed as standard of care, patient will not be eligible
  12. hCentral research labs will be collected at designated sites only.
  13. Abbreviations: CAM-ICU Confusion Assessment Method for the Intensive Care Unit, D/C discharge, GCS Glasgow Coma Scale, RASS Richmond Agitation and Sedation Scale, T. bili total bilirubin, VVFD ventilator- and vasopressor-free day
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