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Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

NCT03215862 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2017-07-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Principal Investigators

  • Pushpak Taunk, MD · University of South Florida

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03215862 on ClinicalTrials.gov