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

NCT ID: NCT06897384

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin C Group

The intervention is the administration of vitamin C via central venous infusion at a rate of 500mg/kg/24h, 2g/h, for a total of 7 days.

Group Type: EXPERIMENTAL

Vitamin C (Ascorbic Acid)

Intervention Type: DRUG

Vitamin C at dose of 500mg/kg/24h, 2g/h

Control Group

The intervention for the control group involves administering the same dosage of normal saline via the same injection method for a total of 7 days.

Group Type: PLACEBO_COMPARATOR

Saline (NaCl 0,9 %)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Vitamin C (Ascorbic Acid)

Vitamin C at dose of 500mg/kg/24h, 2g/h

Intervention Type: DRUG

Other Intervention Names

Vitamin C group

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Time from onset of illness to enrollment is less than 7 days
• Meet the 2012 Atlanta Guidelines SAP diagnostic criteria

Exclusion Criteria

• SAP caused by tumors or ERCP
• Pregnant or breastfeeding
• Allergic to vitamin C
• Use of other experimental drugs within the timeframe of this study
• Chronic organs failure such as heart, liver, lung, or kidney before admission, with specific indicators being (chronic cardiovascular dysfunction requiring long-term mechanical hemodynamic support or inotropic drug support; chronic obstructive pulmonary disease requiring home oxygen therapy; chronic liver dysfunction at Child-Pugh Class C; chronic kidney disease with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m² or serum creatinine greater than 150 μmol/L)
• Immunosuppressed state, including malignant tumors, post-transplant status, long-term use of immunosuppressor (for at least 1 month before enrollment), AIDS, etc.
• The patient and family are unwilling to sign the informed consent form
• Body weight greater than 100kg
• Urinary system stones

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Municipal Science and Technology Commission

OTHER_GOV

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

2024430

Identifier Type: -

Identifier Source: org_study_id