Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mahidol University
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• patients at age between 18-65 years old undergoing first time ERCP

Exclusion Criteria:

• 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)