High Volume Lactated Ringer's Solution and Pancreatitis

Phase 2

Terminated

Brief 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.

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Low Volume Group (Control Arm)	Administration of Lactated Ringer's (LR) Solution	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.
High Volume Group (Intervention Arm)	Administration of Lactated Ringer's (LR) Solution	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

Primary Outcome Measures

Name	Time	Method
Development of Post-ERCP Pancreatitis	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events Related to Fluid Overload	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.

Locations (5): Advocate Health Care
🇺🇸
Skokie, Illinois, United States
Minnesota Gastroenterology
🇺🇸
Plymouth, Minnesota, United States
University of Utah Health Care
🇺🇸
Salt Lake City, Utah, United States
NorthShore University HealthSystem
🇺🇸
Highland Park, Illinois, United States
Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States