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Enhanced Recovery in Acute Pancreatitis (ASERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813876
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Bechien U. Wu, 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.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Other: Enhanced recovery protocol Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Application of Surgical Enhanced Recovery Techniques in Acute Pancreatitis
Actual Study Start Date : June 2016
Actual Primary Completion Date : May 15, 2017
Actual Study Completion Date : May 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Enhanced recovery
Enhanced recovery protocol for nursing, diet and analgesic regimen
Other: Enhanced recovery protocol
No Intervention: Standard care
Standard care arm



Primary Outcome Measures :
  1. Time to tolerance of oral refeeding [ Time Frame: 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 :
  1. Time to disease resolution [ Time Frame: Up to 30 days ]
    Acute Pancreatitis Clinical Activity Index score<50

  2. Satisfaction with inpatient hospital care [ Time Frame: 30 days post-hospitalization ]
    Comparison of overall and pain management satisfaction score based on validated survey instrument



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813876


Locations
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United States, California
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Kaiser Permanente
Investigators
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Principal Investigator: Bechien U Wu, MD, MPH Kaiser Permanente Southern California, Los Angeles Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bechien U. Wu, Center for Pancreatic Care, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02813876    
Other Study ID Numbers: 10920
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases