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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Max Petrov, University of Auckland, New Zealand
ClinicalTrials.gov Identifier:
NCT01128478
First received: May 11, 2010
Last updated: January 5, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Acute Pancreatitis
Procedure: Enteral tube feeding
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Enteral Tube Feeding Compared With Pancreas Rest in Patients With Acute Pancreatitis: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Auckland, New Zealand:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain relapse [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
  • Local and systemic complications [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Feeding intolerance [ Time Frame: Up to 3 months ] [ Designated as safety issue: Yes ]
  • Time to solid oral food tolerated [ Time Frame: Approx. one week ] [ Designated as safety issue: No ]
  • Pain-free time [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
  • Hospital readmission [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: May 2010
Study Completion Date: April 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128478

Locations
New Zealand
University of Auckland
Auckland, New Zealand
Sponsors and Collaborators
University of Auckland, New Zealand
Investigators
Principal Investigator: Max Petrov, MD, MPH (Epi) Universioty of Auckland
  More Information

Publications:
Responsible Party: Max Petrov, Principal Investigator, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT01128478     History of Changes
Other Study ID Numbers: NTX/08/11/107
Study First Received: May 11, 2010
Last Updated: January 5, 2013
Health Authority: New Zealand: Institutional Review Board

Keywords provided by University of Auckland, New Zealand:
Acute pancreatitis
Enteral nutrition
Pancreas rest

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014