Enhanced Recovery in Acute Pancreatitis (ASERT)

Kaiser Permanente

Status and phase

Completed

Phase 2

Conditions

Acute Pancreatitis

Treatments

Other: Enhanced recovery protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT02813876

10920

Details and patient eligibility

About

Prospective randomized-controlled trial evaluating impact of enhanced recovery protocol compared to standard care for recovery of patients with acute pancreatitis.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.