Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis

Study Overview
=================
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.

Official Title
-----------------
Aggressive Fluid Hydration for the Prevention of Post-ERCP Pancreatitis

Conditions
-----------------
Pancreatitis

Intervention / Treatment
-----------------
* Drug: Lactated Ringer's solution


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: standard hydration<br>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. | Drug: Lactated Ringer's solution<br>* 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<br>* Other names: Ringer's Lactated solution;|
| Active Comparator: aggressive hydration<br>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. | Drug: Lactated Ringer's solution<br>* 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<br>* Other names: Ringer's Lactated solution;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post ERCP pancreatitis | 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. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of post ERCP pancreatitis | 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 | 24 hours |