Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

NCT03215862 | Not Yet Recruiting

• 1 other identifier: Pro00029546
• Study Type: interventional
• Target: 242
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, double-blinded, controlled trial. This study is a head to head comparison of normal saline (NS) infusion versus Lactated Ringer's (LR) infusion in patients, with the primary outcome of post-ERCP pancreatitis occurrence. Patients will be randomized to either the NS infusion group or the LR infusion group. IVF will be started pre-procedurally and will be continued throughout the procedure. A IVF bolus will be given at the end of the procedure and then continued as a continuous infusion. Our null hypothesis is that there will be no significant difference in the rate of occurrence of post-ERCP pancreatitis between the infusion of LR and NS solutions. Our alternative hypothesis is that patients receiving LR solution infusion will experience a decreased rate of post-ERCP pancreatitis compared to patients receiving NS solution infusion.

Conditions

Post-ERCP Acute Pancreatitis

Keywords

Post-ERCP Acute Pancreatitis; Normal Saline; Lactated Ringer's

Outcome Measures

Primary Outcomes (1)

• Post-ercp pancreatitis

  The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed.

  24 hours

Study Arms (2)

Control

ACTIVE COMPARATOR

Drug: Normal Saline 0.9% Infusion Solution Bag

Experimental

EXPERIMENTAL

Drug: Lactated Ringer

Interventions

Lactated Ringer DRUG

This is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.

Experimental

Normal Saline 0.9% Infusion Solution Bag DRUG

This is a Normal Saline solution infusion before, during, and after the ERCP procedure.

Control

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i. Possession of one of the following criteria which places the patient at high risk for post-ERCP pancreatitis and/or if patient is to undergo a planned endoscopic intervention deemed at high risk:
• Suspicion of Oddi dysfunction
• Personal history of post-ERCP pancreatitis
• More than 8 cannulation attempts
• Precut sphincterotomy
• Endoscopic papillary balloon dilation of an intact sphincter
• Endoscopic pancreatic duct sphincterotomy
• Ampullectomy
• Total bilirubin \< 1.0
• ii. Or possession of two or more of the following minor criteria:
• Female sex
• Age under 50 years
• Personal history of recurrent acute pancreatitis
• Pancreatic duct injection leading to "acinarization" or over 3 pancreatic duct injections
• Pancreatic duct cytology acquisition

You may not qualify if:

• Patients aged less than 18
• Inability to provide informed consent
• Pregnancy
• Active acute pancreatitis
• Any contraindication to aggressive IVF hydration: evidence of clinical volume overload (peripheral or pulmonary edema), respiratory compromise (oxygen saturation \< 90% on room air), chronic kidney disease (creatinine clearance \< 40 mL/min), systolic congestive heart failure (ejection fraction \< 45%), cirrhosis, and severe electrolyte disturbance with sodium \<130 mEq/L or \>150 mEq/L
• If patient does not undergo a planned high-risk intervention
• If patient does not possess complete criteria which places them at high risk for post-ERCP pancreatitis
• Patients with cholangitis
• Patients with chronic and/or active pancreatitis
• Patients with a true NSAID allergy
• Patients greater than or equal to 75 years old

Sponsors & Collaborators

• University of South Florida: lead

MeSH Terms

Interventions

Ringer's Lactate; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pushpak Taunk, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Primary Investigator

CONTACT

8139743980; ptaunk@health.usf.edu

Researcher

CONTACT

2692676151; rpatel19@health.usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 12, 2017
• Study Start: August 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 12, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share