Home Treatment of Acute Pancreatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ali Tüzün İnce, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT01796652
First received: February 19, 2013
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition
Acute Pancreatitis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: A Randomized Controlled Trial of Home Monitoring Versus Hospitalization in Mild Non-Alcoholic Acute Interstitial Pancreatitis

Resource links provided by NLM:


Further study details as provided by Bezmialem Vakif University:

Primary Outcome Measures:
  • The primary outcome of the study was the 30 day hospital readmission rate. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    30 day hospital readmission of home and hospital groups of patients were evaluated.


Secondary Outcome Measures:
  • 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. [ Time Frame: hours ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 84
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Home and hospital treatment groups
Patients were randomized into either home or hospital groups after a brief hospitalization(≤24 hours. Hospital patients were followed 5 days in hospital.Home patients were visited on 2nd,3rd and 5th days by a staff nurse and the vital signs, symptoms, and general condition were recorded and transmitted back to the attending physician. On the 7th, 14th and 30th days, the home and hospital group patients were requested to return for a follow-up clinic visit at Bezmialem, at which time an assessment of their symptoms, physical examination, and laboratory evaluation was conducted.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Mild acute non-alhololic patients managed in home.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01796652

Locations
Turkey
Bezmialem Vakıf University Hospital, Gastroenterology Clinic
İstanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
Principal Investigator: Hakan Şentürk, Prof. Bezmialem Vakıf University Hospital, Gastroenterology Clinic
  More Information

Publications:
Responsible Party: Ali Tüzün İnce, Asc Prof, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT01796652     History of Changes
Other Study ID Numbers: B.30.2.BAV.0.05.05/374
Study First Received: February 19, 2013
Last Updated: February 21, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Bezmialem Vakif University:
Acute interstitial pancreatitis
Home therapy

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 16, 2014