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Randomized Trial of Aggressive Fluid Hydration to Prevent Post ERCP Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01758549
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
  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 or disease Intervention/treatment
Pancreatitis Other: Aggressive Intravenous Hydration Group Other: Standard Fluids Arm

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Feasibility Study of a Randomized Trial of Aggressive Fluid Hydration to Prevent Post ERCP Pancreatitis
Study Start Date : July 2012
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Clinical volume overload [ Time Frame: 24 hours ]
    Clinical volume overload will be defined by physical findings of lower extremity edema and pulmonary rales.

  2. 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.

  3. 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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
United States, California
Los Angeles County Hospital
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: James L Buxbaum, MD University of Southern California
More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: January 1, 2013    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014

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

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases