drugset / Trial / NCT03215862

Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

NCT03215862

Not yet recruiting 242 enrolled University of South Florida
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2017-08-01
Primary completion
2018-08-01
Completion
2018-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactated Ringer Other / unclassified
Comparator sodium chloride Unknown

Indications