Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01798511




Registration number
NCT01798511
Ethics application status
Date submitted
13/02/2013
Date registered
26/02/2013
Date last updated
26/09/2019

Titles & IDs
Public title
Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION)
Scientific title
A Randomized Controlled Trial of Oral Refeeding Intolerance After Nasogastric Tube Feeding
Secondary ID [1] 0 0
13/NTA/9
Universal Trial Number (UTN)
Trial acronym
ORION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Pancreatitis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Nasogastric Tube Feeding
Other interventions - Conventional Nutritonal Management

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.

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.


Treatment: Surgery: Nasogastric Tube Feeding
A nasogastric tube will be placed into the stomach of patients.

Other interventions: 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)
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of oral food intolerance
Timepoint [1] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcome [1] 0 0
Progression of severity
Timepoint [1] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcome [2] 0 0
Pain relapse
Timepoint [2] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcome [3] 0 0
Use of opioids
Timepoint [3] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Secondary outcome [4] 0 0
Duration of hospital stay
Timepoint [4] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Eligibility
Key inclusion criteria
- Diagnosis of AP

- Age 18 years or older

- Written informed consent

- Ongoing need for opiates
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 96 hours after onset of symptoms

- Chronic pancreatitis

- Post-ERCP pancreatitis

- Intraoperative diagnosis

- Pregnancy

- Malignancy

- Received nutrition before randomisation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2020
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01798511
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Max Petrov, MD, MPH, PhD
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01798511