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

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This study investigates high-dose intravenous vitamin C for sepsis patients. The randomized controlled trial aims to determine if vitamin C reduces death or persistent organ dysfunction within 28 days.

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Area of Science:

  • Critical Care Medicine
  • Nutritional Science
  • Translational Medicine

Background:

  • Sepsis is a critical global health issue requiring effective treatments.
  • Intravenous vitamin C shows potential in reducing sepsis-related mortality.
  • This study addresses the need for robust clinical evidence on vitamin C in sepsis management.

Purpose of the Study:

  • To evaluate the efficacy of high-dose intravenous vitamin C in sepsis patients.
  • To ascertain the effect of vitamin C on the composite endpoint of death or persistent organ dysfunction at 28 days.
  • To provide evidence for vitamin C's role in improving patient outcomes in sepsis.

Main Methods:

  • A multicenter, parallel-group, blinded, superiority randomized controlled trial (RCT) involving at least 800 patients.
  • Patients with sepsis receiving vasopressors in the ICU were randomized to receive high-dose intravenous vitamin C or placebo for 96 hours.
  • The primary outcome was a composite of death or persistent organ dysfunction at day 28, with secondary outcomes including organ dysfunction-free days, mortality, quality of life, and biomarkers.

Main Results:

  • The study is designed to provide definitive evidence on the effectiveness of vitamin C.
  • Results will elucidate the impact of vitamin C on key clinical outcomes in sepsis.
  • Analysis will include subgroup investigations and assessment of various biomarkers and adverse effects.

Conclusions:

  • This randomized controlled trial will offer crucial insights into the clinical utility of high-dose intravenous vitamin C for sepsis.
  • The findings are expected to inform clinical practice guidelines for sepsis management.
  • Evidence generated will focus on patient-important outcomes, including mortality and organ dysfunction.