Home Treatment of Acute Pancreatitis

Completed

• Conditions: Acute Pancreatitis

• Registration Number: NCT01796652
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

Acute pancreatitis (AP) is considered a disease requiring in-hospital treatment. We studied the feasibility of home management in AP.The aim of study was to compare 30 day readmission rates in patients with mild non-alcoholic acute pancreatitis (NAAP) randomized to home monitoring versus hospitalization.

Detailed Description

Between 11/11-5/12, 84 patients with mild NAAP were randomized to home or hospital groups after a short (≤24 hours) hospital stay. AP was defined as ≥2 or more of the following: characteristic abdominal pain, amylase and/or lipase ≥3X the upper limit of normal, and/or imaging findings. Patients with an Imrie's score ≤5 and a harmless acute pancreatitis score (HAPS) ≤2 were included. Patients in both groups received intravenous lactated Ringer for 3 days and pain was treated with intramuscular diclofenac. A nurse visited all patients in the home group on the 2nd, 3rd and 5th day. All patients recalled for follow-up on the 7th, 14th, and 30th days.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-02
• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-02-21
• Last Update Submitted: 2013-02-21
• Study First Posted: 2013-02-22
• Last Update Posted: 2013-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Diagnosis of AP based on 2 out of 3 findings: characteristic abdominal pain, amylase and/or lipase levels ≥3 times the upper limit of normal, and/or abdominal imaging demonstrating changes of acute pancreatitis
• Presentation within 48 hours of symptom onset
• Imrie's scores of ≤5 and HAP score ≤2 within 24 hours of presentation to the hospital
• Lack of hemoconcentration (hematocrit ≥44%) on presentation since hemoconcentration has been shown to be a risk factor for pancreatic necrosis.

Exclusion Criteria

• The presence of organ failure by the Atlanta criteria on the first day of presentation
• The presence of clinical signs and/or symptoms of sepsis
• Alcoholic acute pancreatitis
• A history of abdominal imaging demonstrating a dilated pancreatic duct and/or pancreatic calcifications
• Coagulopathy (international normalized ratio >1, and/or platelet count <50,000/mm3
• Comorbidities requiring hospitalization regardless of the presence of AP e.g. acute myocardial infarction, malignancy, cirrhosis, chronic kidney disease, and chronic pulmonary disease)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study was the 30 day hospital readmission rate.	30 days	30 day hospital readmission of home and hospital groups of patients were evaluated.

Secondary Outcome Measures

Name	Time	Method
Other outcomes evaluated included the duration of abdominal pain and time to resumption of an oral diet, both measured in hours from the time of presentation.	hours	Elaboration time of abdominal pain in home and hospital group patients as hour from the admission time to ICU.; Time to resumption of an oral diet measured from the time of presentation.

Trial Locations

Locations (1)

Bezmialem Vakıf University Hospital, Gastroenterology Clinic; 🇹🇷 İstanbul, Turkey