Frontiers in Medicine (Nov 2023)

Effect of high-dose intravenous vitamin C therapy on the prognosis in patients with moderately severe and severe acute pancreatitis: protocol of a prospective, randomized, double-blinded, placebo-controlled study

  • Wenwu Sun,
  • Bing Zhao,
  • Jiaoyan Li,
  • Yihui Wang,
  • Xing Qi,
  • Ning Ning,
  • Silei Sun,
  • Mengjiao Li,
  • Yi Yao,
  • Tongtian Ni,
  • Li Ma,
  • Juan He,
  • Jun Huang,
  • Zhitao Yang,
  • Ying Chen,
  • Huiqiu Sheng,
  • Enqiang Mao

DOI
https://doi.org/10.3389/fmed.2023.1278167
Journal volume & issue
Vol. 10

Abstract

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IntroductionAcute pancreatitis is a common gastrointestinal disease. The mortality of patients affected by severe acute pancreatitis (SAP) remains high. It is unclear whether high-dose intravenous vitamin C (HDIVC) therapy could improve the prognosis of these patients. The current prospective, randomized, double-blinded, placebo-controlled study will explore the effect of high-dose intravenous vitamin C therapy on the prognosis in patients with moderately severe and severe acute pancreatitis.Methods and designA total of 418 participants with moderately severe and severe acute pancreatitis who meet the eligible criteria will be randomly assigned in a 1:1 ratio to receive treatment with HDIVC (200 mg/kg/24 h) or placebo (saline) for a period of 7 days. The primary outcome is 28-day mortality in these patients. The secondary outcomes include organ functions and interventions, laboratory tests, healthcare, and 90-day mortality.Ethics and disseminationThis protocol was approved by the institutional ethics board of the Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China (Registration Number: 2019-90). The report of the study will be published in peer-reviewed journals and presented at conferences, both nationally and internationally.Clinical trial registrationChinese Clinical Trial Registry (ChiCTR1900022022). Version 1.5.

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