High Volume Lactated Ringer's Solution and Pancreatitis

NorthShore University HealthSystem

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Pancreatitis

Treatments: Other: Administration of Lactated Ringer's (LR) Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02050048

EH 13-130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

High Volume Group (Intervention Arm)

Experimental group

Description:

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

Treatment:

Other: Administration of Lactated Ringer's (LR) Solution

Low Volume Group (Control Arm)

Active Comparator group

Description:

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.

Treatment:

Other: Administration of Lactated Ringer's (LR) Solution