NCT06260878招募中4 期
Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 505
- 试验地点
- 2
- 主要终点
- Serum amylase
研究概览
简要总结
This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients >75 years of age)
- •ability to give informed consent
- •native major papillary anatomy
- •ability and willingness to obtain bloodwork the day after ERCP
排除标准
- •prior ERCP with sphincterotomy and/or sphincteroplasty
- •confirmed or suspected cholangitis or sepsis
- •confirmed pancreatitis, hyperlipasemia, or hyperamylasemia within the preceding 7 days
- •NYHA Class II or greater heart failure
- •active pulmonary edema
- •myocardial infarction or ischemia within the preceding 3 months
- •renal insufficiency with CrCl < 40 mL/minute
- •CPT Class B or C cirrhosis and/or end-stage liver disease
- •room air oxygen saturation <90% or requirement of home O2
- •hypernatremia with Na+ ≥ 150 mEq/L or Na+ <130 mEq/L
- •uncontrolled hypertension or hypotension
- •pregnant status
结局指标
主要结局
Serum amylase
时间窗: 24 hours
次要结局
- Cholangitis(14 days)
- Brain natriuretic peptide(24 hours)
- Cardiorespiratory adverse event(7 days)
- Serum lipase(24 hours)
- Creatinine(24 hours)
- Pancreatitis(7 days)
- Bleeding(30 days)
- Electrolytes(24 hours)
研究者
研究点 (2)
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