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Randomized Trial of Aggressive Fluid Hydration to Prevent Post ERCP Pancreatitis

This study is currently recruiting participants.
Verified December 2012 by University of Southern California
Sponsor:
Information provided by (Responsible Party):
James Buxbaum, University of Southern California
ClinicalTrials.gov Identifier:
NCT01758549
First received: November 25, 2012
Last updated: December 24, 2012
Last verified: December 2012
History of Changes
  Purpose
  1. 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.
  2. Post ERCP pancreatitis (PEP) complicates 5-15% of biliary endoscopic procedures and results in considerable suffering and cost.
  3. Patients with acute pancreatitis are treated with fluids.
  4. Our aim is to assess whether prophylactic treatment with aggressive intravenous hydration prevents ERCP pancreatitis.
  5. 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 Intervention
Pancreatitis
 Other: Aggressive Intravenous Hydration Group
Other: Standard Fluids Arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Feasibility Study of a Randomized Trial of Aggressive Fluid Hydration to Prevent Post ERCP Pancreatitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Acute Pancreatitis [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Clinical volume overload [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Serum amylase three times the upper limit of normal is a secondary outcome measure.

  • Increased abdominal pain [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All Inpatients aged 18 to 70 years undergoing ERCP for the first time
  • Patients undergoing ERCP for standard clinical indications

Exclusion Criteria:

  • Ongoing acute pancreatitis
  • Ongoing hypotension including those with sepsis
  • Cardiac insufficiency (CI, >NYHA Class II heart failure)
  • Renal insufficiency (RI, creatinine clearance <40mL/min)
  • Severe liver dysfunction (albumin < 3mg/dL)
  • Respiratory insufficiency (defined as oxygen saturation < 90%)
  • Greater than 70 years of age
  • Pregnancy
  • Hyponatremia (Na+ levels < 135mEq/L))
  • Hypernatremia (Na+ levels > 150mEq/L) will be excluded.
  • Edema or anasarca
  • Ascites
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758549

Contacts
Contact: Maria Trujillo 323 409 0939 mit@usc.edu
Contact: James Buxbaum, MD 323 409 5371 jbuxbaum@usc.edu

Locations
United States, California
Los Angeles County Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: James Buxbaum, MD     323-409-5371     buxbaum@usc.edu    
Contact: Maria Trujillo     323 409 6939     mit@usc.edu    
Principal Investigator: James Buxbaum, MD            
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: James L Buxbaum, MD University of Southern California
  More Information

Publications:

Responsible Party: James Buxbaum, Director of Endoscopy, University of Southern California, University of Southern California
ClinicalTrials.gov Identifier: NCT01758549     History of Changes
Other Study ID Numbers: HS-10-00576
Study First Received: November 25, 2012
Last Updated: December 24, 2012
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Southern California:
pancreatitis
cholangiopancreatography, endoscopic retrograde
hyperamylasemia

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013