Clinical trial NCT02050048: High Volume Lactated Ringer's Solution and Pancreatitis
Official title: Perioperative Intravenous Administration of High Volume Lactated Ringer's Solution and the Risk of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Pancreatitis
Keywords: Pancreatitis
Endoscopic retrograde cholangiopancreatography
Cholangiopancreatography, Endoscopic Retrograde
ERCP
High Volume
Lactated Ringer
Intravenous Administration
Sphincterotomy, Endoscopic
Pancreas
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
name: Allina Health System
name: Wake Forest University Health Sciences
name: University of Utah
First posted: 2014-01-30
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Development of Post-ERCP Pancreatitis
timeFrame: Assessed 90 minutes after procedure, 5 days after procedure, and 29 days after procedure
Secondary outcomes:
measure: Number of Participants With Adverse Events Related to Fluid Overload
timeFrame: Phase II portion (~1 year)
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Highland Park
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Skokie
country: United States
facility: Advocate Health Care
state: Illinois
city: Plymouth
country: United States
facility: Minnesota Gastroenterology
state: Minnesota
city: Salt Lake City
country: United States
facility: University of Utah Health Care
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Endeavor Health
name: Russell Brown, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Coast Gastroenterology
name: Mick Meiselman, MD
role: STUDY_DIRECTOR
affiliation: Medical College of Wisconsin
name: Zachary Smith, MD
role: STUDY_DIRECTOR
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