Randomized Trial of Aggressive Fluid Hydration to Prevent Post ERCP Pancreatitis
Completed · Not applicable
Conditions studied: Pancreatitis
In brief
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.
Key facts
- Study ID
- NCT01758549
- Run by
- University of Southern California
- People needed
- 62
- Starts
- 2012-07-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2014-07-01
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All Inpatients aged 18 to 70 years undergoing ERCP for the first time
- Patients undergoing ERCP for standard clinical indications
You may not qualify if…
- 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
Where it is running
- Los Angeles County Hospital — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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