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OpenTrials
Completed

NCT Number: NCT02813876

Enhanced Recovery in Acute Pancreatitis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced recovery protocol

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

Application of Surgical Enhanced Recovery Techniques in Acute Pancreatitis

Acronym: ASERT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 27, 2016
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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