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
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: 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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 20, 2014