Clinical trial NCT06897384: High-dose Intravenous Vitamin C for the Treatment of Severe Acute Pancreatitis
Official title: High-dose Intravenous Vitamin C for the Treatment of Severe Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Severe Acute Pancreatitis
Keywords: high-dose intravenous vitamin C
severe acute pancreatitis
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Science and Technology Commission
First posted: 2025-03-26
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mortality rate in ICU
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: The Impact of HDIVC on Free Organ Support Duration (FOSD) within 14 Days of Enrollment
timeFrame: 14 days of enrollment
measure: 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
timeFrame: 28 days of enrollment
measure: the Duration of Systemic Inflammatory Response Syndrome (SIRS)
timeFrame: 28 days of enrollment
measure: The Impact of HDIVC on Sequential Organ Failure Assessment (SOFA) Score
timeFrame: 28 days of enrollment
measure: The Impact of HDIVC on Modified Marshall Score
timeFrame: 28 days of enrollment
measure: The Impact of HDIVC on Fluid Retention
timeFrame: 28 days of enrollment
measure: The Impact of HDIVC on Acute Physiology and Chronic Health Evaluation II (APACHE II) Score
timeFrame: 28 days of enrollment
measure: The Impact of HDIVC on Bedside Index for Severity in Acute Pancreatitis (BISAP) Score
timeFrame: 28 days of enrollment
measure: The Impact of HDIVC on Pancreatic Necrosis, namely Computed Tomography Severity Index (CTSI).
timeFrame: 28 days of enrollment
measure: The Incidence of IPN (Infection-Related Pancreatic Necrosis)
timeFrame: 28 days of enrollment
measure: ICU Stay Duration
timeFrame: through study completion, an average of 6 months
measure: Hospitalization Costs
timeFrame: through study completion, an average of 6 months
measure: Plasma Concentration of Vitamin C Before and After Treatment
timeFrame: 28 days of enrollment
measure: Adverse events related to Vitamin C
timeFrame: 28 days of enrollment
measure: The Impact of HDIVC on the Composition of the Gut Microbiota
timeFrame: 28 days of enrollment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital
state: Shanghai
Study officials:
References: