Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

NCT ID: NCT03215862

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2018-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control

Group Type: ACTIVE_COMPARATOR

Normal Saline 0.9% Infusion Solution Bag

Intervention Type: DRUG

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

Experimental

Group Type: EXPERIMENTAL

Lactated Ringer

Intervention Type: DRUG

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

Interventions

Lactated Ringer

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

Intervention Type: DRUG

Normal Saline 0.9% Infusion Solution Bag

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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:

1. Suspicion of Oddi dysfunction

2. Personal history of post-ERCP pancreatitis

3. More than 8 cannulation attempts

4. Precut sphincterotomy

5. Endoscopic papillary balloon dilation of an intact sphincter

6. Endoscopic pancreatic duct sphincterotomy

7. Ampullectomy

8. Total bilirubin < 1.0

ii. Or possession of two or more of the following minor criteria:

1. Female sex

2. Age under 50 years

3. Personal history of recurrent acute pancreatitis

4. Pancreatic duct injection leading to "acinarization" or over 3 pancreatic duct injections

5. Pancreatic duct cytology acquisition

Exclusion Criteria

1. Patients aged less than 18

2. Inability to provide informed consent

3. Pregnancy

4. Active acute pancreatitis

5. 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

6. If patient does not undergo a planned high-risk intervention

7. If patient does not possess complete criteria which places them at high risk for post-ERCP pancreatitis

8. Patients with cholangitis

9. Patients with chronic and/or active pancreatitis

10. Patients with a true NSAID allergy

11. Patients greater than or equal to 75 years old

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pushpak Taunk, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Central Contacts

Primary Investigator

Role: CONTACT

ptaunk@health.usf.edu

8139743980

Researcher

Role: CONTACT

rpatel19@health.usf.edu

2692676151

Other Identifiers

Pro00029546

Identifier Type: -

Identifier Source: org_study_id