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:10.3389/fmed.2023.1278167

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

Front Med (Lausanne). 2023 Nov 9:10:1278167. doi: 10.3389/fmed.2023.1278167. eCollection 2023.

Authors

Wenwu Sun^#¹, Bing Zhao^#¹, Jiaoyan Li^#¹, Yihui Wang¹, Xing Qi¹, Ning Ning¹, Silei Sun¹, Mengjiao Li¹, Yi Yao¹, Tongtian Ni¹, Li Ma¹, Juan He², Jun Huang³, Zhitao Yang¹, Ying Chen¹, Huiqiu Sheng¹, Enqiang Mao¹

Affiliations

¹ Department of Emergency, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
² Department of Pharmacy, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
³ Department of Cardiovascular Medicine, State Key Laboratory of Medical Genomics, Shanghai Key Laboratory of Hypertension, Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

^# Contributed equally.

Abstract

Introduction: Acute 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 design: A 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 dissemination: This 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 registration: Chinese Clinical Trial Registry (ChiCTR1900022022). Version 1.5.

Keywords: acute pancreatitis; intravenous infusion; protocol; randomized controlled trials; vitamin C.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This trial was supported by Shanghai Municipal Science and Technology Commission (Grant No. 18411966400). The funding sponsors were involved neither in study design, collection, management, analysis, interpretation of data, report writing nor in the decision to submit the report for publication.