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High Volume Lactated Ringer's Solution and Pancreatitis

NCT02050048 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-09-06

Study results available
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Summary

The purpose of this study is to examine whether giving large amounts of intravenous (IV) fluids will reduce the risk of developing a complication known as post-ERCP pancreatitis (PEP). Pancreatitis is inflammation of the pancreas, and it is the most frequent serious complication of ERCP. Typically, a small amount of IV fluids are given during this procedure (\~ 1 liter). We are testing whether using a larger amount of fluids (2 - 3 liters) will reduce the risk of PEP.

Conditions

Interventions

OTHER

Administration of Lactated Ringer's (LR) Solution

Patients will be randomized to low volume or high volume group. Patient in the low volume group will receive fluids via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period. Patients in the high volume group will receive fluids via infusion by the following weight based regimen: * initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour * LR fluid infusion during the procedure at 5 cc/kg/hr * Post-procedure bolus of 20 cc/kg over 90 minutes

Sponsors & Collaborators

  • Medical College of Wisconsin

    collaborator OTHER

  • Allina Health System

    collaborator OTHER

  • Wake Forest University Health Sciences

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • Endeavor Health

    lead OTHER

Principal Investigators

  • Russell Brown, MD · Endeavor Health

  • Mick Meiselman, MD · Central Coast Gastroenterology

  • Zachary Smith, MD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Diseases
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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 NCT02050048 on ClinicalTrials.gov