Perioperative Intravenous Administration of High Volume Lactated Ringer's Solution and the Risk of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 11
- 主要终点
- Development of Post-ERCP Pancreatitis
研究概览
简要总结
The purpose of this study is to examine whether giving large amounts of intravenous (IV) fluids will reduce the risk of developing a complication known as post-ERCP pancreatitis (PEP). Pancreatitis is inflammation of the pancreas, and it is the most frequent serious complication of ERCP. Typically, a small amount of IV fluids are given during this procedure (~ 1 liter). We are testing whether using a larger amount of fluids (2 - 3 liters) will reduce the risk of PEP.
详细描述
This trial is designed as a phase II/III study. The phase II portion of the trial will be completed to establish safety and efficacy data prior to proceeding with a phase III study. The phase II trial will enroll 110 patients that are undergoing elective ERCP as outpatients. Following the phase II portion, if the data suggests that the intervention arm (high volume group) is safe, the investigators will begin enrolling patients who are undergoing ERCP in a more urgent setting as inpatients.
We plan on enrolling 1,400 consecutive high risk patients undergoing ERCP. We are assuming a baseline PEP risk of 9.2%. Fluid administration will be based on Ideal Body Weight (IBW) in order to standardize the aggressive fluid administration across all body weights and reduce the potential for adverse cardiopulmonary outcomes.
All participants will be monitored for 90 minutes following their procedure to assess the development of any adverse symptoms. Analysis by a data safety monitoring board (DSMB) will take place throughout the study. The DSMB is comprised of a panel of experts independent of NorthShore University HealthSystem.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients to be included in the study are those undergoing ERCP with the following:
- •Clinical suspicion of sphincter of Oddi dysfunction
- •History of post-ERCP pancreatitis (at least one episode)
- •Pancreatic sphincterotomy
- •Pre-cut (access) sphincterotomy
- •Ampullectomy
排除标准
- •Age < 18 years old
- •Intrauterine pregnancy or breastfeeding mother
- •Congestive heart failure
- •Advanced/symptomatic coronary artery disease
- •Known ascites
- •Renal failure
- •Active or recent gastrointestinal hemorrhage
- •Acute pancreatitis within 72 hours prior to ERCP
研究组 & 干预措施
High Volume Group (Intervention Arm)
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
- initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
- LR fluid infusion during the procedure at 5 cc/kg/hr
- Post-procedure bolus of 20 cc/kg over 90 minutes
干预措施: Administration of Lactated Ringer's (LR) Solution (Other)
Low Volume Group (Control Arm)
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
干预措施: Administration of Lactated Ringer's (LR) Solution (Other)
结局指标
主要结局
Development of Post-ERCP Pancreatitis
时间窗: Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure
Patients will be monitored after procedure to see if they develop abdominal pain. If so, serum amylase and lipase blood draws will be completed at least once every 24 hours following procedure to monitor the development of post-ERCP pancreatitis. If patients do not develop abdominal pain following the procedure, research staff will follow up with the patients 5 days and 29 days after the procedure to evaluate for the development of post-ERCP pancreatitis and other related or unrelated complications.
次要结局
- Number of Participants With Adverse Events Related to Fluid Overload(Phase II portion (~1 year))
研究者
Rachel Pulido
Russelll Brown, M.D.
NorthShore University HealthSystem