Last updated: December 4, 2020
Sponsor: University of Cincinnati
Overall Status: Active - Enrolling
Phase
4
Condition
Pancreatitis
Treatment
N/AClinical Study ID
NCT04282200
2019-0283
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 years old
- opioid order for pain secondary to acute pancreatitis
- diagnosis of acute pancreatitis defined by the presence of two of the following threecriteria: abdominal pain, lipase > 3x upper limit of normal, and/or findings of AP onimaging
- a patient with acute-on-chronic pancreatitis that does not exhibit elevated lipaselevels is eligible for inclusion if the patient has the other two criteria
- received at least 3 L of IV crystalloid fluid within first 24 hours of admission toensure patients have received initial volume expansion
- hemodynamically stable represented by a mean arterial blood pressure (MAP) of ≥65 mmHg
- female patients not documented in chart as post-menopause must have a negativepregnancy test
Exclusion
Exclusion Criteria:
- history of chronic heart failure
- history of acute coronary syndrome (ST-elevation myocardial infarction (STEMI) ornon-ST elevation myocardial infarction (NSTEMI)) within last 6 months
- history of ischemic or hemorrhagic stroke within last 6 months
- history of upper gastrointestinal bleed (GI) within last 6 months
- history of inflammatory bowel disease
- history of cirrhosis
- any overt, active bleeding requiring blood transfusion
- considered to be high bleed risk (platelet < 50,000/mcL)
- pregnant or breastfeeding
- prisoners
- cognitively impaired patients: not alert and oriented to person, place, and time (patient must be able to consent)
- allergy to NSAIDs, ketorolac, or aspirin
- admission to an intensive care unit
- evidence of infected pancreatitis (i.e. abscess) on imaging studies
- acute kidney injury or chronic kidney disease with CrCl<30
Study Design
Total Participants: 60
Study Start date:
February 24, 2020
Estimated Completion Date:
December 31, 2022
Study Description
Connect with a study center
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesSite Not Available
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