Enhanced Recovery in Acute Pancreatitis

NCT02813876 | Completed Phase 2

• 1 other identifier: 10920
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Time to disease resolution

  Up to 30 days

• Satisfaction with inpatient hospital care

  30 days post-hospitalization

Study Arms (2)

Enhanced recovery

EXPERIMENTAL

Enhanced recovery protocol for nursing, diet and analgesic regimen

Other: Enhanced recovery protocol

Standard care

NO INTERVENTION

Standard care arm

Interventions

Enhanced recovery protocol OTHER

Enhanced recovery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute pancreatitis confirmed by clinical history, serologic testing and/or radiographic imaging

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Related Publications (1)

• Dong E, Chang JI, Verma D, Butler RK, Villarin CK, Kwok KK, Chen W, Wu BU. Enhanced Recovery in Mild Acute Pancreatitis: A Randomized Controlled Trial. Pancreas. 2019 Feb;48(2):176-181. doi: 10.1097/MPA.0000000000001225.

  PMID: 30629020 DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Bechien U Wu, MD, MPH

  Kaiser Permanente Southern California, Los Angeles Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center for Pancreatic Care

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 27, 2016
• Study Start: June 1, 2016
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (1)