Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Lactated Ringer's solution

Intervention Type DRUG

Standard fluid hydration with Lactated Ringer's solution is calculated based on Holiday Segar's equation Aggressive hydration with Lactated Ringer's solution is defined as administration of 150 ml/hour of fluid

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.

Group Type ACTIVE_COMPARATOR

Lactated Ringer's solution

Intervention Type DRUG

Standard fluid hydration with Lactated Ringer's solution is calculated based on Holiday Segar's equation Aggressive hydration with Lactated Ringer's solution is defined as administration of 150 ml/hour of fluid

Interventions

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Lactated Ringer's solution

Standard fluid hydration with Lactated Ringer's solution is calculated based on Holiday Segar's equation Aggressive hydration with Lactated Ringer's solution is defined as administration of 150 ml/hour of fluid

Intervention Type DRUG

Other Intervention Names

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Ringer's Lactated solution

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No