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

NCT06897384 | Active Not Recruiting DMC

• 1 other identifier: 2024430
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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

Keywords

high-dose intravenous vitamin C; severe acute pancreatitis

Outcome Measures

Primary Outcomes (1)

• Mortality rate in ICU

  through study completion, an average of 6 months

Secondary Outcomes (15)

• The Impact of HDIVC on Free Organ Support Duration (FOSD) within 14 Days of Enrollment

  14 days of enrollment

• The Impact of HDIVC on Early Inflammatory Markers in SAP, Including the Levels and Changes of C-Reactive Protein and Inflammatory Cytokines IL-6, IL-1, and IL-10

  28 days of enrollment

• the Duration of Systemic Inflammatory Response Syndrome (SIRS)

  28 days of enrollment

• The Impact of HDIVC on Sequential Organ Failure Assessment (SOFA) Score

  28 days of enrollment

• The Impact of HDIVC on Modified Marshall Score

  28 days of enrollment

Study Arms (2)

Vitamin C Group

EXPERIMENTAL

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.

Drug: Vitamin C (Ascorbic Acid)

Control Group

PLACEBO COMPARATOR

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.

Drug: Saline (NaCl 0,9 %)

Interventions

Saline (NaCl 0,9 %) 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.

Control Group

Vitamin C (Ascorbic Acid) DRUG

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

Also known as: Vitamin C group

Vitamin C Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai Municipal Science and Technology Commission: collaborator

Study Sites (1)

Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Sodium Chloride; Ascorbic Acid

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 26, 2025
• Study Start: March 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 26, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)