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

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ClinicalTrials.gov Identifier: NCT01128478
Recruitment Status : Completed
First Posted : May 24, 2010
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):
Max Petrov, University of Auckland, New Zealand

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.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Procedure: Enteral tube feeding Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Enteral Tube Feeding Compared With Pancreas Rest in Patients With Acute Pancreatitis: a Randomized Controlled Trial
Study Start Date : May 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Up to 3 months ]

Secondary Outcome Measures :
  1. Pain relapse [ Time Frame: Up to 3 months ]
  2. Local and systemic complications [ Time Frame: Up to 3 months ]
  3. Feeding intolerance [ Time Frame: Up to 3 months ]
  4. Time to solid oral food tolerated [ Time Frame: Approx. one week ]
  5. Pain-free time [ Time Frame: Up to 3 months ]
  6. Hospital readmission [ Time Frame: Up to 6 months ]
  7. Quality of life [ Time Frame: Up to 6 months ]
  8. Mortality [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: May 24, 2010    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents