NCT06897384

High-dose Intravenous Vitamin C for the Treatment of Severe Acute Pancreatitis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 388 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized, double-blinded, parallel-controlled, multi-central clinical trial for patients with severe acute pancreatitis (SAP). Patients with SAP in the early stage (within 7 days of onset) and over the age of 18, based on the routine treatment, will be randomly divided into a high-dose intravenous vitamin C group (HDIVC, 500mg/kg/24h, administered by iv. pump at a rate of 2g/h for 7 days) and a control group (an equal volume of normal saline). The primary endpoint is mortality rate in ICU, and secondary endpoints include free organ support duration (FOSD) within 14 days after enrollment, changes in inflammatory response and severity, disease severity scores and changes, fluid retention, incidence of infectious pancreatic necrosis (IPN), ICU mortality, pancreatic necrosis scores, monitoring of vitamin C plasma concentrations before and after HDIVC use, composition of gut microbiota, observation of vitamin C-related adverse reactions. The study hypothesis is that HDIVC can reduce mortality rate in ICU, significantly decrease the FOSD within 14 days and significantly reduce inflammatory response, decrease fluid retention, and improve disease severity.

Conditions

• Severe Acute Pancreatitis

Interventions

Type	Name	Description
DRUG	Saline (NaCl 0,9 %)	The control group involves only adding 50ml of normal saline to a 50ml syringe, without any labels to ensure identical appearance, and the method of administration and dosage are the same with vitamin C group.
DRUG	Vitamin C (Ascorbic Acid)	Vitamin C at dose of 500mg/kg/24h, 2g/h

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-01-01
• Completion: 2027-12-31
• First posted: 2025-03-26
• Last updated: 2025-03-26

Locations

1 site across 1 country: China