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Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION) (ORION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798511
Recruitment Status : Withdrawn (No funding)
First Posted : February 26, 2013
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Max Petrov, University of Auckland, New Zealand

Brief Summary:
Acute pancreatitis (AP) is one of the most common diseases in routine clinical practice of surgeons and gastroenterologists throughout the world. The high rate of pain relapse after oral refeeding contributes to high consumption of healthcare resources and prolonged hospital stay in AP patients. The data from the pilot MIMOSA trial suggest that early administration of nasogastric tube feeding may prevent pain relapse after oral refeeding in AP. The potential beneficial effects of enteral tube feeding include induction of postprandial gastrointestinal motility and improving the tolerance of oral refeeding. This may reduce the risk of pain relapse, thereby shortening length of hospital stay and reducing cost of treatment. The primary endpoint of the ORION trial will be the incidence of oral food intolerance. All eligible AP patients will be randomly allocated to either the Early Nasogastric Tube (ENT) group or Conventional Nutritional Management group (CNM) at 24h of hospital admission.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Procedure: Nasogastric Tube Feeding Other: Conventional Nutritonal Management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Oral Refeeding Intolerance After Nasogastric Tube Feeding
Estimated Study Start Date : April 1, 2013
Estimated Primary Completion Date : April 1, 2015
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Nasogastric Tube Feeding
Patients who are to have NTF will receive enteral nutrition within 6 hours after randomisation via a nasogastric tube placed into the stomach. A commercially available low fat semi-elemental feed (Peptisorb®, Nutricia Clinical NZ) will be used. The caloric target will be 2000 kcal per day. Enteral tube feeding will be commenced at a rate of 30 mL/h and increased gradually until 100 mL/h over 24-48 h.
Procedure: Nasogastric Tube Feeding
A nasogastric tube will be placed into the stomach of patients.

Active Comparator: Conventional Nutritional Management
Patients who are to have CNM will be on nil-by-mouth regimen until they either develop signs of severe AP (in which case enteral tube feeding will be introduced) or the signs of AP mitigate,in which case clear liquids (as tolerated) followed by oral food (as tolerated) will be introduced.
Other: Conventional Nutritonal Management
Patients who are to have CNM will be on nil-by-mouth regimen until they either develop signs of severe AP (in which case nasojejunal tube feeding will be introduced) or the signs of AP mitigate (in which case clear liquids (as tolerated) followed by oral food (as tolerated) will be introduced)




Primary Outcome Measures :
  1. Incidence of oral food intolerance [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]

Secondary Outcome Measures :
  1. Progression of severity [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
  2. Pain relapse [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
  3. Use of opioids [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]
  4. Duration of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks ]


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 AP
  • Age 18 years or older
  • Written informed consent
  • Ongoing need for opiates

Exclusion Criteria:

  • 96 hours after onset of symptoms
  • Chronic pancreatitis
  • Post-ERCP pancreatitis
  • Intraoperative diagnosis
  • Pregnancy
  • Malignancy
  • Received nutrition before randomisation

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): NCT01798511


Locations
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New Zealand
University of Auckland
Auckland, New Zealand
Sponsors and Collaborators
University of Auckland, New Zealand
Investigators
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Principal Investigator: Max Petrov, MD, MPH, PhD University of Auckland, New Zealand
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Responsible Party: Max Petrov, Principal Investigator Dr. Max Petrov, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT01798511    
Other Study ID Numbers: 13/NTA/9
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Keywords provided by Max Petrov, University of Auckland, New Zealand:
enteral nutrition
acute pancreatitis
oral food intolerance
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases