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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator |
| |
| Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactated Ringer | Drug | This is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-ercp pancreatitis | The occurrence of pancreatitis as a complication of ERCP procedure, assessed 24 hours after the procedure is completed. | 24 hours |
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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:
ii. Or possession of two or more of the following minor criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Primary Investigator | Contact | 8139743980 | ptaunk@health.usf.edu | |
| Researcher | Contact | 2692676151 | rpatel19@health.usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pushpak Taunk, MD | University of South Florida | Principal Investigator |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 21, 2020 | Nov 10, 2020 | 1 |
| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal Saline 0.9% Infusion Solution Bag | Drug | This is a Normal Saline solution infusion before, during, and after the ERCP procedure. |
|