Acute Pancreatitis
Conditions
Brief summary
Prospective randomized-controlled trial evaluating impact of enhanced recovery protocol compared to standard care for recovery of patients with acute pancreatitis.
Interventions
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Non-English speaking patients for whom an appropriate language interpretor cannot be identified. * Pregnant women will be excluded from participation in this phase IIb trial given the limited projected sample size and rarity of this condition during pregnancy. * Minors (patients \<18 years of age) will not be eligible for study inclusion. The interventions being compared in the study protocol are standard care for adult patients with acute pancreatitis. However, the safety and efficacy of these treatments in the pediatric population has not been established.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to tolerance of oral refeeding | Up to 7 days | Resumption of intake of 50% of solid meal without symptoms of worsening post-prandial abdominal pain, nausea or vomiting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to disease resolution | Up to 30 days | Acute Pancreatitis Clinical Activity Index score\<50 |
| Satisfaction with inpatient hospital care | 30 days post-hospitalization | Comparison of overall and pain management satisfaction score based on validated survey instrument |
Countries
United States
Outcome results
None listed