Effect of high-dose intravenous vitamin C on organ support-free days within the first 14 days in severe acute pancreatitis patients: a multicenter, randomized, double-blind, placebo-controlled clinical trial protocol.

BACKGROUND

The global incidence of severe acute pancreatitis (SAP) is increasing, yet mortality rates remain persistently high. Novel therapeutic approaches are urgently needed to improve outcomes. The aim of this study is to evaluate the efficacy of high-dose intravenous vitamin C in improving organ support-free days within the first 14 days and other clinical outcomes in patients with SAP.

METHOD: This is a prospective, randomized, double-blind, multicenter clinical trial. Participants will be stratified and randomly assigned to either the HDIVC group or the control group. Data will be analyzed using SAS 9.4 with two-sided tests and a significance threshold of p < 0.05. This study will be conduct at eight hospitals in China, including Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital, Shanghai General Hospital, Changhai Hospital, Sichuan Provincial People's Hospital, Chongqing Daping Hospital, The Second People's Hospital of Chengdu, Guanghan People's Hospital and Chongqing Emergency Medical Center. Eligible patients are adults (age ≥ 18 years) diagnosed with severe acute pancreatitis according to 2012 Atlanta classification within 7 days of onset. HDIVC (500 mg/kg, 2 g/h) or placebo (normal saline) will be administered via central vein for 7 days. The primary outcome is organ support-free days within the first 14 days. Secondary outcomes include ICU all-cause mortality, changes in inflammatory biomarkers, and organ failure scores.

DISCUSSION: If proven effective, the results of this trial could establish high-dose intravenous vitamin C as a cost-effective adjunctive therapy to improve survival in patients with severe acute pancreatitis and potentially inform future clinical practice guidelines.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT06897384.