search
Back to results

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

Primary Purpose

Acute Pancreatitis

Status
Completed
Phase
Phase 2
Locations
New Zealand
Study Type
Interventional
Intervention
Enteral tube feeding
Sponsored by
University of Auckland, New Zealand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Pancreatitis focused on measuring Acute pancreatitis, Enteral nutrition, Pancreas rest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Auckland

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Enteral tube feeding

Nil-per-mouth regimen

Arm Description

Nasogastric tube feeding started within 24 h of hospital admission

Conventional management

Outcomes

Primary Outcome Measures

Length of hospital stay

Secondary Outcome Measures

Pain relapse
Local and systemic complications
Feeding intolerance
Time to solid oral food tolerated
Pain-free time
Hospital readmission
Quality of life
Mortality

Full Information

First Posted
May 11, 2010
Last Updated
January 5, 2013
Sponsor
University of Auckland, New Zealand
search

1. Study Identification

Unique Protocol Identification Number
NCT01128478
Brief Title
MIld to MOderate Acute Pancreatitis: Early naSogastric Tube Feeding Compared With pAncreas Rest (MIMOSA)
Acronym
MIMOSA
Official Title
Early Enteral Tube Feeding Compared With Pancreas Rest in Patients With Acute Pancreatitis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Auckland, New Zealand

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
Acute pancreatitis, Enteral nutrition, Pancreas rest

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enteral tube feeding
Arm Type
Other
Arm Description
Nasogastric tube feeding started within 24 h of hospital admission
Arm Title
Nil-per-mouth regimen
Arm Type
No Intervention
Arm Description
Conventional management
Intervention Type
Procedure
Intervention Name(s)
Enteral tube feeding
Intervention Description
Nasogastric tube feeding started within 24 h of hospital admission
Primary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Pain relapse
Time Frame
Up to 3 months
Title
Local and systemic complications
Time Frame
Up to 3 months
Title
Feeding intolerance
Time Frame
Up to 3 months
Title
Time to solid oral food tolerated
Time Frame
Approx. one week
Title
Pain-free time
Time Frame
Up to 3 months
Title
Hospital readmission
Time Frame
Up to 6 months
Title
Quality of life
Time Frame
Up to 6 months
Title
Mortality
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Max Petrov, MD, MPH (Epi)
Organizational Affiliation
Universioty of Auckland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Auckland
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
17686077
Citation
Petrov MS. Enteral nutrition: goody or good-for-nothing in acute pancreatitis? Am J Gastroenterol. 2007 Aug;102(8):1828-9; author reply 1829-30. doi: 10.1111/j.1572-0241.2007.01361.x. No abstract available.
Results Reference
background
PubMed Identifier
17573797
Citation
Petrov MS, van Santvoort HC, Besselink MG, Cirkel GA, Brink MA, Gooszen HG. Oral refeeding after onset of acute pancreatitis: a review of literature. Am J Gastroenterol. 2007 Sep;102(9):2079-84; quiz 2085. doi: 10.1111/j.1572-0241.2007.01357.x. Epub 2007 Jun 16.
Results Reference
background
PubMed Identifier
18331767
Citation
Petrov MS. To feed or not to feed early in acute pancreatitis: still depend on severity? Clin Nutr. 2008 Apr;27(2):317-8. doi: 10.1016/j.clnu.2008.01.011. Epub 2008 Mar 10. No abstract available.
Results Reference
background
PubMed Identifier
23340042
Citation
Petrov MS, McIlroy K, Grayson L, Phillips AR, Windsor JA. Early nasogastric tube feeding versus nil per os in mild to moderate acute pancreatitis: a randomized controlled trial. Clin Nutr. 2013 Oct;32(5):697-703. doi: 10.1016/j.clnu.2012.12.011. Epub 2012 Dec 31.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs