NCT03215862

Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

The Effect of the Use of Lactated Ringer's Solution During ERCP on Rate of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-ERCP Acute Pancreatitis

Interventions

Type	Name	Description
DRUG	Lactated Ringer	This is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.
DRUG	Normal Saline 0.9% Infusion Solution Bag	This is a Normal Saline solution infusion before, during, and after the ERCP procedure.

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2017-07-12
• Last updated: 2017-07-12