NCT02813876
Completed
Phase 2
Application of Surgical Enhanced Recovery Techniques in Acute Pancreatitis
ConditionsAcute Pancreatitis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Acute Pancreatitis
- Sponsor
- Kaiser Permanente
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Time to tolerance of oral refeeding
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Prospective randomized-controlled trial evaluating impact of enhanced recovery protocol compared to standard care for recovery of patients with acute pancreatitis.
Investigators
Bechien U. Wu
Center for Pancreatic Care
Kaiser Permanente
Eligibility Criteria
Inclusion Criteria
- •Acute pancreatitis confirmed by clinical history, serologic testing and/or radiographic imaging
Exclusion Criteria
- •• Severe acute pancreatitis defined as the presence of any of the following:
- •Organ failure (oxygen saturation\<90% on room air, mean arterial pressure\<70 mmHG or any requirement for vasopressor or inotropic support, serum creatinine\>2.0, Glasgow coma score\<15)
- •Suspected or confirmed infected pancreatic necrosis: fever, leukocytosis in the setting of suspicious findings on cross-sectional imaging (gas within necrotic collection) or confirmed infection on fine needle aspirate
- •Chronic pancreatitis or any chronic pain syndrome requiring use of narcotic analgesic within 30 days prior to hospitalization
- •Abdominal surgery within 60 days prior to hospitalization
- •History of gastrointestinal motility disorder
- •Inflammatory bowel disease
- •Chronic comorbid illness including but not limited to \>New York Heart Association Class II congestive heart failure, cirrhosis, oxygen-dependent chronic obstructive pulmonary disease or malignancy other than non-squamous skin cancer not in remission.
- •Documented allegy to any of the following medications: dilaudid, Tylenol
- •Patients transferred from an outside hospital for ongoing care
Outcomes
Primary Outcomes
Time to tolerance of oral refeeding
Time Frame: Up to 7 days
Resumption of intake of 50% of solid meal without symptoms of worsening post-prandial abdominal pain, nausea or vomiting
Secondary Outcomes
- Satisfaction with inpatient hospital care(30 days post-hospitalization)
- Time to disease resolution(Up to 30 days)
Study Sites (1)
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