High Volume Lactated Ringer's Solution and Pancreatitis

Stopped early · Phase 2/Phase 3

Conditions studied: Pancreatitis

In brief

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.

Key facts

Study ID: NCT02050048
Run by: Endeavor Health
People needed: 26
Starts: 2014-01-01
Expected to finish: 2016-01-01
Last updated by the study team: 2019-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

NorthShore University HealthSystem — Evanston, Illinois, United States
NorthShore University HealthSystem — Highland Park, Illinois, United States
Advocate Health Care — Skokie, Illinois, United States
Minnesota Gastroenterology — Plymouth, Minnesota, United States
University of Utah Health Care — Salt Lake City, Utah, United States
Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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