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

Shanghai Jiao Tong University

Status: Active, not recruiting

Conditions: Severe Acute Pancreatitis

Treatments: Drug: Vitamin C (Ascorbic Acid); Drug: Saline (NaCl 0,9 %)

Study type: Interventional

Funder types: Other

Identifiers

NCT06897384

2024430

Details and patient eligibility

About

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.

Enrollment: 388 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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388 participants in 2 patient groups, including a placebo group

Vitamin C Group

Experimental group

Description:

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.

Treatment:

Drug: Vitamin C (Ascorbic Acid)

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline (NaCl 0,9 %)