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Enhanced Recovery in Acute Pancreatitis (ASERT)

Primary Purpose

Acute Pancreatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enhanced recovery protocol
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kaiser Permanente Los Angeles Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Enhanced recovery

Standard care

Arm Description

Enhanced recovery protocol for nursing, diet and analgesic regimen

Standard care arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to disease resolution
Acute Pancreatitis Clinical Activity Index score<50
Satisfaction with inpatient hospital care
Comparison of overall and pain management satisfaction score based on validated survey instrument

Full Information

First Posted
June 23, 2016
Last Updated
May 24, 2017
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT02813876
Brief Title
Enhanced Recovery in Acute Pancreatitis
Acronym
ASERT
Official Title
Application of Surgical Enhanced Recovery Techniques in Acute Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
May 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced recovery
Arm Type
Experimental
Arm Description
Enhanced recovery protocol for nursing, diet and analgesic regimen
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard care arm
Intervention Type
Other
Intervention Name(s)
Enhanced recovery protocol
Primary Outcome Measure Information:
Title
Time to tolerance of oral refeeding
Description
Resumption of intake of 50% of solid meal without symptoms of worsening post-prandial abdominal pain, nausea or vomiting
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
Time to disease resolution
Description
Acute Pancreatitis Clinical Activity Index score<50
Time Frame
Up to 30 days
Title
Satisfaction with inpatient hospital care
Description
Comparison of overall and pain management satisfaction score based on validated survey instrument
Time Frame
30 days post-hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bechien U Wu, MD, MPH
Organizational Affiliation
Kaiser Permanente Southern California, Los Angeles Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30629020
Citation
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.
Results Reference
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Enhanced Recovery in Acute Pancreatitis

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