High Volume Lactated Ringer's Solution and Pancreatitis

This study has been terminated.
(Study was closed prematurely due to low enrollment numbers.)
Sponsor:
Collaborators:
Medical College of Wisconsin
Abbott Northwestern Hospital
Advocate Health Care
University of Utah
Information provided by (Responsible Party):
NorthShore University HealthSystem
ClinicalTrials.gov Identifier:
NCT02050048
First received: January 27, 2014
Last updated: June 13, 2016
Last verified: June 2016
  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:
  • Development of Post-ERCP Pancreatitis [ 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.


Enrollment: 26
Study Start Date: January 2014
Study Completion Date: January 2016
Primary Completion Date: January 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   (Adult, Senior)
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

Locations
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
NorthShore University HealthSystem
Highland Park, Illinois, United States, 60035
Advocate Health Care
Skokie, Illinois, United States, 60076
United States, Minnesota
Minnesota Gastroenterology
Plymouth, Minnesota, United States, 55446
United States, Utah
University of Utah Health Care
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
NorthShore University HealthSystem
Medical College of Wisconsin
Abbott Northwestern Hospital
Advocate Health Care
University of Utah
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
  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
Results First Received: March 29, 2016
Last Updated: June 13, 2016
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

ClinicalTrials.gov processed this record on July 21, 2016