Enhanced Recovery in Acute Pancreatitis

Acute Pancreatitis Clinical Trial

— ASERT  

Official title:

Application of Surgical Enhanced Recovery Techniques in Acute Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813876
• Other study ID #: 10920
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2016
• Last updated: May 24, 2017
• Start date: June 2016
• Est. completion date: May 15, 2017

Study information

• Verified date: May 2017
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Other:
• Enhanced recovery protocol

Locations

Country	Name	City	State
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to tolerance of oral refeeding	Resumption of intake of 50% of solid meal without symptoms of worsening post-prandial abdominal pain, nausea or vomiting	Up to 7 days
Secondary	Time to disease resolution	Acute Pancreatitis Clinical Activity Index score<50	Up to 30 days
Secondary	Satisfaction with inpatient hospital care	Comparison of overall and pain management satisfaction score based on validated survey instrument	30 days post-hospitalization