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NCT03215862

Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

Not yet recruiting NA Last updated 12 July 2017
What this trial tests

NA trial testing Lactated Ringer in Post-ERCP Acute Pancreatitis in 242 participants. Not yet recruiting.

Timeline
1 August 2017
Primary endpoint
1 August 2018
1 August 2018

Quick facts

Lead sponsorUniversity of South Florida
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment242
Start date1 August 2017
Primary completion1 August 2018
Estimated completion1 August 2018

Drugs / interventions tested

Conditions studied

Sponsor

University of South Florida

Who can join

Adults 18 to 74, any sex, with Post-ERCP Acute Pancreatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy of aggressive hydration with normal saline versus lactated Ringer's solution for the prevention of post-ERCP pancreatitis in high-risk patients: a randomized controlled trial.
    Patel R, Bertran-Rodriguez C, Kumar A, Brady P, et al · · 2022 · cited 5× · PMID 35845031 · DOI 10.1055/a-1834-6568

Verify or expand the search:

Other trials of Lactated Ringer

Trials testing the same drug.

Other recruiting trials for Post-ERCP Acute Pancreatitis

Currently open trials in the same condition.

Other University of South Florida trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03215862.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing