Enhanced Recovery in Acute Pancreatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-05-15

Brief Summary

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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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Detailed Description

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Conditions

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Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Enhanced recovery

Enhanced recovery protocol for nursing, diet and analgesic regimen

Group Type EXPERIMENTAL

Enhanced recovery protocol

Intervention Type OTHER

Standard care

Standard care arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Enhanced recovery protocol

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No