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Table 1 LOVIT trial timeline

From: Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial

TIME POINTSStudy Period
DaysDaysMonths
Enrolment/AllocationPost-Allocation 
12345–678–91011–131415–27286 months
ENROLMENT:
 Eligibility screenx            
 Informed consentx            
 Allocationx            
INTERVENTION:
 Vitamin C or placeboxxxx         
ASSESSMENTS:
 Baseline variables
  Source of infectionx            
  Severity of illness (APACHE II score)x            
  Pre-existing comorbidities (Charlson comorbidity index, Clinical Frailty Score)x            
  Vitamin C levelax            
 Primary outcome
  Death or persistent organ dysfunctionb           x 
 Secondary outcomes
  Persistent organ dysfunction-free days in ICU, up to day 28bxxxxxxxxxxxx 
  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)xxxx 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 AKIcxxxxxxxxxxxx 
  Acute hemolysisxxxxxxxxxxxx 
  Hypoglycemiadxxxxxxxxx    
 Other variables
  Protocol adherenceexxxx         
  Co-interventionsfxxxxxxxxxx x 
  1. AKI acute kidney injury, ANG-2 angiopoietin-2, APACHE II score Acute Physiology and Chronic Health Evaluation II score, CRP C-reactive protein, EQ-5D-5 L questionnaire EuroQol-5D (EQ-5D), HRQoL: health-related quality of life, ICU intensive care unit, IL-1ß interleukin-1 beta, PCT procalcitonin, SOFA score Sequential Organ Failure Assessment score, TM thrombomodulin, TNF-α tumor necrosis factor-alpha
  2. aMust be collected before the first dose of investigational product
  3. bDependency on mechanical ventilation, RRT, or vasopressors
  4. cAs defined by KDIGO (Kidney Disease: Improving Global Outcomes) criteria22
  5. dAssessed by core lab (during the time participants receive the 16 doses of the investigational product and the 7 days following the last dose)
  6. eReceipt of every planned dose according to schedule until completion of 96-h treatment protocol, samples collected per protocol instructions, vitamin C baseline collected before the first dose of investigational product
  7. fAdministration of mechanical ventilation, RRT, vasopressors, corticosteroids, thiamine, intravenous fluids, blood products, sedatives, and antimicrobials. Daily data until ICU discharge or 28 days (whichever comes first)