High Volume Lactated Ringer's Solution and Pancreatitis

August 26, 2019 updated by: Rachel Pulido, NorthShore University HealthSystem

Perioperative Intravenous Administration of High Volume Lactated Ringer's Solution and the Risk of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This trial is designed as a phase II/III study. The phase II portion of the trial will be completed to establish safety and efficacy data prior to proceeding with a phase III study. The phase II trial will enroll 110 patients that are undergoing elective ERCP as outpatients. Following the phase II portion, if the data suggests that the intervention arm (high volume group) is safe, the investigators will begin enrolling patients who are undergoing ERCP in a more urgent setting as inpatients.

We plan on enrolling 1,400 consecutive high risk patients undergoing ERCP. We are assuming a baseline PEP risk of 9.2%. Fluid administration will be based on Ideal Body Weight (IBW) in order to standardize the aggressive fluid administration across all body weights and reduce the potential for adverse cardiopulmonary outcomes.

All participants will be monitored for 90 minutes following their procedure to assess the development of any adverse symptoms. Analysis by a data safety monitoring board (DSMB) will take place throughout the study. The DSMB is comprised of a panel of experts independent of NorthShore University HealthSystem.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • NorthShore University HealthSystem
      • Highland Park, Illinois, United States, 60035
        • NorthShore University HealthSystem
      • Skokie, Illinois, United States, 60076
        • Advocate Health Care
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Gastroenterology
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Care
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients to be included in the study are those undergoing ERCP with the following:

  • Clinical suspicion of sphincter of Oddi dysfunction
  • History of post-ERCP pancreatitis (at least one episode)
  • Pancreatic sphincterotomy
  • Pre-cut (access) sphincterotomy
  • Ampullectomy

Exclusion Criteria:

  • Age < 18 years old
  • Intrauterine pregnancy or breastfeeding mother
  • Congestive heart failure
  • Advanced/symptomatic coronary artery disease
  • Known ascites
  • Renal failure
  • Active or recent gastrointestinal hemorrhage
  • Acute pancreatitis within 72 hours prior to ERCP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High Volume Group (Intervention Arm)

Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. 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
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
ACTIVE_COMPARATOR: Low Volume Group (Control Arm)
Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of Post-ERCP Pancreatitis
Time Frame: Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure
Patients will be monitored after procedure to see if they develop abdominal pain. If so, serum amylase and lipase blood draws will be completed at least once every 24 hours following procedure to monitor the development of post-ERCP pancreatitis. If patients do not develop abdominal pain following the procedure, research staff will follow up with the patients 5 days and 29 days after the procedure to evaluate for the development of post-ERCP pancreatitis and other related or unrelated complications.
Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events Related to Fluid Overload
Time Frame: Phase II portion (~1 year)
A portion of the study will assess whether there is a significant risk of adverse events related to fluid overload states in the high volume (HV) intervention arm. We anticipate the rate of adverse events in patients randomized to the HV arm to be small. By using more modest, weight based regimens, we aim to optimize benefit while eliminating overly aggressive fluid administration and causing undue harm.
Phase II portion (~1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NorthShore University HealthSystem

Collaborators

Medical College of Wisconsin
University of Utah
Advocate Health Care
Allina Health System

Investigators

  • Principal Investigator: Russell Brown, MD, NorthShore University HealthSystem
  • Study Director: Mick Meiselman, MD, Central Coast Gastroenterology
  • Study Director: Zachary Smith, MD, Medical College of Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 28, 2014

First Posted (ESTIMATE)

January 30, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH 13-130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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