High Volume Lactated Ringer's Solution and Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by NorthShore University HealthSystem
Sponsor:
Collaborators:
University of Southern California
Medical College of Wisconsin
Rockford Gastroenterology Associates
Abbott Northwestern Hospital
Advocate Health Care
Information provided by (Responsible Party):
NorthShore University HealthSystem
ClinicalTrials.gov Identifier:
NCT02050048
First received: January 27, 2014
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Pancreatitis
Other: Administration of Lactated Ringer's (LR) Solution
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Perioperative Intravenous Administration of High Volume Lactated Ringer's Solution and the Risk of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Resource links provided by NLM:


Further study details as provided by NorthShore University HealthSystem:

Primary Outcome Measures:
  • Change from Recovery in Development of Post-ERCP Pancreatitis at 5 and 29 Days [ Time Frame: Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants with Adverse Events Related to Fluid Overload [ Time Frame: Phase II portion (~1 year) ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 1400
Study Start Date: January 2014
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050048

Contacts
Contact: Asantewaa Ture, BA 847-570-3708 ature@northshore.org

Locations
United States, California
USC Care Medical Group Not yet recruiting
Los Angeles, California, United States, 90089
Contact: Maria Trjillo    323-442-6515    mit@usc.edu   
Principal Investigator: James L. Buxbaum, MD         
United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Asantewaa Ture, BA    847-570-3708    ature@northshore.org   
Principal Investigator: Mick Meiselman, MD         
Sub-Investigator: Eric Elton, MD         
Sub-Investigator: Michael Goldberg, MD         
NorthShore University HealthSystem Recruiting
Highland Park, Illinois, United States, 60035
Contact: Asantewaa Ture, BA    847-570-3708    ature@northshore.org   
Sub-Investigator: Shailesh Bajaj, MD         
Advocate Health Care Not yet recruiting
Skokie, Illinois, United States, 60076
Contact: Sarosh Bukhari, MD    847-677-1170      
Principal Investigator: Alan Shapiro, MD         
United States, Minnesota
Minnesota Gastroenterology Recruiting
Plymouth, Minnesota, United States, 55446
Contact: Karen Swenson, RN, PhD    612-863-5658    karen.swenson2@allina.com   
Contact: Erin Turpin, BS, CCRC    612-863-9215    erin.turpin@allina.com   
Principal Investigator: Federico Rossi, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Zachary Smith, MD    414-955-6830    zsmith@mcw.edu   
Principal Investigator: Zachary Smith, MD         
Sponsors and Collaborators
NorthShore University HealthSystem
University of Southern California
Medical College of Wisconsin
Rockford Gastroenterology Associates
Abbott Northwestern Hospital
Advocate Health Care
Investigators
Principal Investigator: Mick Meiselman, MD NorthShore University HealthSystem
  More Information

Additional Information:
Publications:

Responsible Party: NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT02050048     History of Changes
Other Study ID Numbers: EH 13-130
Study First Received: January 27, 2014
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NorthShore University HealthSystem:
Pancreatitis
Endoscopic retrograde cholangiopancreatography
Cholangiopancreatography, Endoscopic Retrograde
ERCP
High Volume
Lactated Ringer
Intravenous Administration
Sphincterotomy, Endoscopic
Pancreas

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014