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

Primary Purpose

Acute Pancreatitis

Status
Withdrawn
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Nasogastric Tube Feeding
Conventional Nutritonal Management
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 enteral nutrition, acute pancreatitis, oral food intolerance

Eligibility Criteria

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

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

Sites / Locations

  • University of Auckland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nasogastric Tube Feeding

Conventional Nutritional Management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of oral food intolerance

Secondary Outcome Measures

Progression of severity
Pain relapse
Use of opioids
Duration of hospital stay

Full Information

First Posted
February 13, 2013
Last Updated
September 24, 2019
Sponsor
University of Auckland, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT01798511
Brief Title
Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION)
Acronym
ORION
Official Title
A Randomized Controlled Trial of Oral Refeeding Intolerance After Nasogastric Tube Feeding
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
April 1, 2013 (Anticipated)
Primary Completion Date
April 1, 2015 (Anticipated)
Study Completion Date
April 1, 2020 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
enteral nutrition, acute pancreatitis, oral food intolerance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasogastric Tube Feeding
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Nutritional Management
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Nasogastric Tube Feeding
Intervention Description
A nasogastric tube will be placed into the stomach of patients.
Intervention Type
Other
Intervention Name(s)
Conventional Nutritonal Management
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Progression of severity
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Title
Pain relapse
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Title
Use of opioids
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Title
Duration of hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

10. Eligibility

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

12. IPD Sharing Statement

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Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION)

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