The Effect of the Use of Lactated Ringer's Solution During ERCP on Rate of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Overview
- Phase
- Not Applicable
- Intervention
- Normal Saline 0.9% Infusion Solution Bag
- Conditions
- Post-ERCP Acute Pancreatitis
- Sponsor
- University of South Florida
- Enrollment
- 242
- Primary Endpoint
- Post-ercp pancreatitis
- Status
- Not yet recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a randomized, double-blinded, controlled trial. This study is a head to head comparison of normal saline (NS) infusion versus Lactated Ringer's (LR) infusion in patients, with the primary outcome of post-ERCP pancreatitis occurrence. Patients will be randomized to either the NS infusion group or the LR infusion group. IVF will be started pre-procedurally and will be continued throughout the procedure. A IVF bolus will be given at the end of the procedure and then continued as a continuous infusion. Our null hypothesis is that there will be no significant difference in the rate of occurrence of post-ERCP pancreatitis between the infusion of LR and NS solutions. Our alternative hypothesis is that patients receiving LR solution infusion will experience a decreased rate of post-ERCP pancreatitis compared to patients receiving NS solution infusion.
Investigators
Eligibility Criteria
Inclusion Criteria
- •i. Possession of one of the following criteria which places the patient at high risk for post-ERCP pancreatitis and/or if patient is to undergo a planned endoscopic intervention deemed at high risk:
- •Suspicion of Oddi dysfunction
- •Personal history of post-ERCP pancreatitis
- •More than 8 cannulation attempts
- •Precut sphincterotomy
- •Endoscopic papillary balloon dilation of an intact sphincter
- •Endoscopic pancreatic duct sphincterotomy
- •Ampullectomy
- •Total bilirubin \< 1.0
- •ii. Or possession of two or more of the following minor criteria:
Exclusion Criteria
- •Patients aged less than 18
- •Inability to provide informed consent
- •Active acute pancreatitis
- •Any contraindication to aggressive IVF hydration: evidence of clinical volume overload (peripheral or pulmonary edema), respiratory compromise (oxygen saturation \< 90% on room air), chronic kidney disease (creatinine clearance \< 40 mL/min), systolic congestive heart failure (ejection fraction \< 45%), cirrhosis, and severe electrolyte disturbance with sodium \<130 mEq/L or \>150 mEq/L
- •If patient does not undergo a planned high-risk intervention
- •If patient does not possess complete criteria which places them at high risk for post-ERCP pancreatitis
- •Patients with cholangitis
- •Patients with chronic and/or active pancreatitis
- •Patients with a true NSAID allergy
- •Patients greater than or equal to 75 years old
Arms & Interventions
Control
Intervention: Normal Saline 0.9% Infusion Solution Bag
Experimental
Intervention: Lactated Ringer
Outcomes
Primary Outcomes
Post-ercp pancreatitis
Time Frame: 24 hours
The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed.