High-dose Intravenous Vitamin C for the Treatment of Severe Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 388
- 试验地点
- 1
- 主要终点
- Mortality rate in ICU
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Time from onset of illness to enrollment is less than 7 days
- •Meet the 2012 Atlanta Guidelines SAP diagnostic criteria
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Vitamin C (Ascorbic Acid) (Drug)
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.
干预措施: Saline (NaCl 0,9 %) (Drug)
结局指标
主要结局
Mortality rate in ICU
时间窗: through study completion, an average of 6 months
次要结局
- 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 Incidence of IPN (Infection-Related Pancreatic Necrosis)(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)
- The Impact of HDIVC on Fluid Retention(28 days of enrollment)
- The Impact of HDIVC on Acute Physiology and Chronic Health Evaluation II (APACHE II) Score(28 days of enrollment)
- The Impact of HDIVC on Bedside Index for Severity in Acute Pancreatitis (BISAP) Score(28 days of enrollment)
- ICU Stay Duration(through study completion, an average of 6 months)
- Plasma Concentration of Vitamin C Before and After Treatment(28 days of enrollment)
- The Impact of HDIVC on Pancreatic Necrosis, namely Computed Tomography Severity Index (CTSI).(28 days of enrollment)
- Adverse events related to Vitamin C(28 days of enrollment)
- Hospitalization Costs(through study completion, an average of 6 months)
- The Impact of HDIVC on the Composition of the Gut Microbiota(28 days of enrollment)