From: Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial
TIME POINTS | Study Period | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Days | Days | Months | |||||||||||
Enrolment/Allocation | Post-Allocation | Â | |||||||||||
1 | 2 | 3 | 4 | 5–6 | 7 | 8–9 | 10 | 11–13 | 14 | 15–27 | 28 | 6 months | |
ENROLMENT: | |||||||||||||
 Eligibility screen | x |  |  |  |  |  |  |  |  |  |  |  |  |
 Informed consent | x |  |  |  |  |  |  |  |  |  |  |  |  |
 Allocation | x |  |  |  |  |  |  |  |  |  |  |  |  |
INTERVENTION: | |||||||||||||
 Vitamin C or placebo | x | x | x | x |  |  |  |  |  |  |  |  |  |
ASSESSMENTS: | |||||||||||||
 Baseline variables | |||||||||||||
  Source of infection | x |  |  |  |  |  |  |  |  |  |  |  |  |
  Severity of illness (APACHE II score) | x |  |  |  |  |  |  |  |  |  |  |  |  |
  Pre-existing comorbidities (Charlson comorbidity index, Clinical Frailty Score) | x |  |  |  |  |  |  |  |  |  |  |  |  |
  Vitamin C levela | x |  |  |  |  |  |  |  |  |  |  |  |  |
 Primary outcome | |||||||||||||
  Death or persistent organ dysfunctionb |  |  |  |  |  |  |  |  |  |  |  | x |  |
 Secondary outcomes | |||||||||||||
  Persistent organ dysfunction-free days in ICU, up to day 28b | x | x | x | x | x | x | x | x | x | x | x | x |  |
  Mortality at 6 months |  |  |  |  |  |  |  |  |  |  |  |  | x |
  HRQoL (EQ-5D-5 L) |  |  |  |  |  |  |  |  |  |  |  |  | x |
  Global tissue dysoxia (serum lactate concentration) | x |  | x |  |  | x |  |  |  |  |  |  |  |
  Organ function including renal function (SOFA score) | x | x | x | x |  | x |  | x |  | x |  | x |  |
  Inflammation biomarkers (IL-1ß, TNF-α, CRP) | x |  | x |  |  | x |  |  |  |  |  |  |  |
  Infection biomarkers (PCT) | x |  | x |  |  | x |  |  |  |  |  |  |  |
  Endothelial injury biomarkers (TM, ANG-2) | x |  | x |  |  | x |  |  |  |  |  |  |  |
 Occurrence of stage 3 AKIc | x | x | x | x | x | x | x | x | x | x | x | x |  |
  Acute hemolysis | x | x | x | x | x | x | x | x | x | x | x | x |  |
  Hypoglycemiad | x | x | x | x | x | x | x | x | x |  |  |  |  |
 Other variables | |||||||||||||
  Protocol adherencee | x | x | x | x |  |  |  |  |  |  |  |  |  |
  Co-interventionsf | x | x | x | x | x | x | x | x | x | x |  | x |  |