Randomized Trial of Aggressive Fluid Hydration to Prevent Post ERCP Pancreatitis
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|ClinicalTrials.gov Identifier: NCT01758549|
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : July 1, 2014
- ERCP is a commonly performed endoscopic procedure used to treat stones and blockages of the bile duct as well as to manage leaks which occurs following laparoscopic gallbladder removal.
- Post ERCP pancreatitis (PEP) complicates 5-15% of biliary endoscopic procedures and results in considerable suffering and cost.
- Patients with acute pancreatitis are treated with fluids.
- Our aim is to assess whether prophylactic treatment with aggressive intravenous hydration prevents ERCP pancreatitis.
- In a blinded fashion patients will be randomized to aggressive intravenous versus moderate hydration during and aftere ERCP for standard clinical indications.
Our hypothesis is that prophylactic treatment with aggressive intravenous hydration protects against ERCP pancreatitis.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis||Other: Aggressive Intravenous Hydration Group Other: Standard Fluids Arm||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Feasibility Study of a Randomized Trial of Aggressive Fluid Hydration to Prevent Post ERCP Pancreatitis|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: Aggressive Intravenous Hydration Group
Patients randomized to the aggressive intravenous hydration group receive lactated ringers (LR) IV at 3 mL kg-1 hr-1 during the procedure, a 20cc/kg LR IV bolus immediately afterward, and LR IV at 3 mL kg-1 hr-1 for 8 hours following the procedure.
Other: Aggressive Intravenous Hydration Group
Patients in the intravenous hydration group wll be treated with lactated ringer infusion at a rate of 3cc/kg/hour during the procedure, be given a bolus of 20cc/kg immediately afterward and receive an infusion of 3cc/kg/hour for 8 hours after the procedure.
Active Comparator: Standard Fluids Arm
Those in the control arm receive standard fluids defined as LR at 1.5 mL kg-1 hr-1 during the procedure and for 8 hours afterwards.
Other: Standard Fluids Arm
Patients randomized to the standard fluids arm will receive lactated ringers at an infusion rate of 1.5cc/kg/hour during the procedure, will receive no bolus, and will receive an infusion of lactated ringers at 1.5cc/kg for 8 hours after the procedure.
- Acute Pancreatitis [ Time Frame: 24 hours ]The primary endpoint is post ERCP pancreatitis which is defined as increased abdominal pain and a serum amylase level three times the upper limit of normal (3xULN). Increased pain will be defined as an increase in the visual analog pain score compared to the value immediately prior to ERCP
- Clinical volume overload [ Time Frame: 24 hours ]Clinical volume overload will be defined by physical findings of lower extremity edema and pulmonary rales.
- Serum amylase three times the upper limit of normal [ Time Frame: 24 hours ]Serum amylase three times the upper limit of normal is a secondary outcome measure.
- Increased abdominal pain [ Time Frame: 24 hours ]Increased abdominal pain is defined as an increase in abdominal pain based on the visual analogue score following the ERCP compared to the score immediately prior to the ERCP.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758549
|United States, California|
|Los Angeles County Hospital|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||James L Buxbaum, MD||University of Southern California|