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

NCT06897384 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2025-03-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shanghai Municipal Science and Technology Commission

    collaborator OTHER_GOV

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-01-01
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06897384 on ClinicalTrials.gov