Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Pancreatitis

Treatments: Drug: Lactated Ringer's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02821546

Si416/2014

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 286 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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286 participants in 2 patient groups, including a placebo group

standard hydration

Placebo Comparator group

Description:

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.

Treatment:

Drug: Lactated Ringer's solution

aggressive hydration

Active Comparator group

Description:

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.

Treatment:

Drug: Lactated Ringer's solution