Enhanced Recovery in Acute Pancreatitis

Phase 2

Completed

• Conditions: Acute Pancreatitis
• Interventions: Other: Enhanced recovery protocol

• Registration Number: NCT02813876
• Lead Sponsor: Kaiser Permanente

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-27
• Status Verified: 2017-05
• Primary Completion: 2017-05-15
• Study Completion: 2017-05-15
• Last Update Submitted: 2017-05-24
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced recovery	Enhanced recovery protocol	Enhanced recovery protocol for nursing, diet and analgesic regimen

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States