Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- post ERCP pancreatitis
研究概览
简要总结
Aggressive hydration with lactated Ringer's solution (LRS) has been shown in a preliminary research to reduce the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. This randomized, controlled trial was designed to assess the effect of peri-procedural aggressive intravenous hydration with LRS on the incidence of post ERCP pancreatitis.
详细描述
Patients underwent first-time ERCP were randomly assigned (1:1) to receive either LRS at a rate of 150 ml/hr starting 2 hours prior to procedure, and continued during and after procedure to complete 24 hours (aggressive hydration) or LRS at a rate calculated by the Holliday-Segar method given peri-procedurally as described earlier (standard hydration). Visual analog scale, serum amylase, lipase, C-reactive protein (CRP), and urine analysis were assessed prior to procedure and 24 hours after. The primary endpoint was post ERCP pancreatitis defined as new or increased epigastric pain persisting for ≥24 hours, elevation of amylase or lipase >3 times the upper limit of normal.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients at age between 18-65 years old undergoing first time ERCP
排除标准
- •Ongoing acute pancreatitis
- •Chronic pancreaittis
- •Prior sphincterotomy
- •Ongoing hypotension including those with sepsis
- •Cardiac insufficiency (CI, >NYHA Class II heart failure)
- •Renal insufficiency (RI, creatinine clearance <40mL/min)
- •Severe liver dysfunction (albumin < 3mg/dL)
- •Respiratory insufficiency (defined as oxygen saturation < 90%)
- •Pregnancy
- •Hyponatremia (Na+ levels < 130mEq/L))
- •Hypernatremia (Na+ levels > 150mEq/L)
研究组 & 干预措施
standard hydration
Patients underwent first-time ERCP to receive standard fluid hydration with Lactated Ringer's solution at a rate calculated by the Holliday-Segar method given peri-procedurally starting 2 hours prior to procedure, and continued during and after procedure to complete 24 hours.
干预措施: Lactated Ringer's solution (Drug)
aggressive hydration
Patients underwent first-time ERCP to receive aggressive fluid hydration with Lactated Ringer's solution at a rate of 150 ml/hr starting 2 hours prior to procedure, and continued during and after procedure to complete 24 hours.
干预措施: Lactated Ringer's solution (Drug)
结局指标
主要结局
post ERCP pancreatitis
时间窗: 24 hours
Post ERCP pancreatitis is defined as hyperamylasemia (amylase \>3 times the upper limit of normal \[300 U/L\]) and pancreatic pain (epigastric abdominal pain radiating to the back scored by patient as development of or increase of pain ≥3 on a 0-10 visual analogue pain scale and persisting for ≥24 hours after ERCP). In those who had pain before the procedure, pancreatic pain is defined as an increase of ≥3 on the 0-10 visual analogue scale.
次要结局
- severity of post ERCP pancreatitis(24 hours)
研究者
Nonthalee Pausawasdi
Associate Professor
Mahidol University