MIld to MOderate Acute Pancreatitis: Early naSogastric Tube Feeding Compared With pAncreas Rest (MIMOSA) (MIMOSA)

January 5, 2013 updated by: Max Petrov, University of Auckland, New Zealand

Early Enteral Tube Feeding Compared With Pancreas Rest in Patients With Acute Pancreatitis: a Randomized Controlled Trial

Pain relapse during oral refeeding occurs in at least one-fifth of patients with acute pancreatitis. The study hypothesis is that early administered enteral tube feeding might reduce a risk of pain relapse and shorten the length of hospital stay in patients with acute pancreatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • University of Auckland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of acute pancreatitis
  • age 18 years or older
  • written informed consent

Exclusion Criteria:

  • > 96 hours after onset of symptoms
  • > 24 hours after hospital admission
  • organ failure by the time of randomization
  • infectious complications before randomization
  • received artificial nutrition before randomization
  • previously enrolled into the trial
  • chronic pancreatitis
  • post-ERCP pancreatitis
  • intraoperative diagnosis of acute pancreatitis
  • pregnancy
  • malignancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Enteral tube feeding
Nasogastric tube feeding started within 24 h of hospital admission
Procedure: Enteral tube feeding
Nasogastric tube feeding started within 24 h of hospital admission
NO_INTERVENTION: Nil-per-mouth regimen
Conventional management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: Up to 3 months
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: Up to 6 months
Up to 6 months
Pain relapse
Time Frame: Up to 3 months
Up to 3 months
Local and systemic complications
Time Frame: Up to 3 months
Up to 3 months
Feeding intolerance
Time Frame: Up to 3 months
Up to 3 months
Time to solid oral food tolerated
Time Frame: Approx. one week
Approx. one week
Pain-free time
Time Frame: Up to 3 months
Up to 3 months
Hospital readmission
Time Frame: Up to 6 months
Up to 6 months
Mortality
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Auckland, New Zealand

Investigators

  • Principal Investigator: Max Petrov, MD, MPH (Epi), Universioty of Auckland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (ESTIMATE)

May 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 5, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTX/08/11/107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Pancreatitis

Clinical Trials on Enteral tube feeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe