Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis

Phase 3

Completed

• Conditions: Pancreatitis
• Interventions: Drug: Lactated Ringer's solution

• Registration Number: NCT02821546
• Lead Sponsor: Mahidol University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-07-01
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-26
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard hydration	Lactated Ringer's solution	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.
aggressive hydration	Lactated Ringer's solution	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.

Primary Outcome Measures

Name	Time	Method
post ERCP pancreatitis	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.

Secondary Outcome Measures

Name	Time	Method
severity of post ERCP pancreatitis	24 hours	severity is defined by length of hospital stay, mild pancreatitis is defined by hospitalization of 48 hours, moderate pancreatitis is defined by hospitalization of more than 48 hours without additional intervention, severe pancreatitis is defined by hospitalization of greater than 72 hours and/or requiring intervention

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkok, Thailand