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Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

Primary Purpose

Post-ERCP Acute Pancreatitis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Lactated Ringer

Normal Saline 0.9% Infusion Solution Bag

About this trial

This is an interventional prevention trial for Post-ERCP Acute Pancreatitis focused on measuring Post-ERCP Acute Pancreatitis, Normal Saline, Lactated Ringer's

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Outcomes

Primary Outcome Measures

Post-ercp pancreatitis

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03215862

First Posted

July 10, 2017

Last Updated

July 10, 2017

Sponsor

University of South Florida

1. Study Identification

Unique Protocol Identification Number

NCT03215862

Brief Title

Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

Official Title

The Effect of the Use of Lactated Ringer's Solution During ERCP on Rate of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2017 (Anticipated)

Primary Completion Date

August 1, 2018 (Anticipated)

Study Completion Date

August 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of South Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-ERCP Acute Pancreatitis

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

242 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Active Comparator

Arm Title

Experimental

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Lactated Ringer

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Normal Saline 0.9% Infusion Solution Bag

Intervention Description

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

Primary Outcome Measure Information:

Title

Post-ercp pancreatitis

Description

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

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

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: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Primary Investigator

Phone

8139743980

ptaunk@health.usf.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Researcher

Phone

2692676151

rpatel19@health.usf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pushpak Taunk, MD

Organizational Affiliation

University of South Florida

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Lactated Ringer's Solution to Prevent Post-ERCP Pancreatitis

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