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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01728896
Registration number
NCT01728896
Ethics application status
Date submitted
5/11/2012
Date registered
20/11/2012
Date last updated
26/09/2019
Titles & IDs
Public title
Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)
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Scientific title
A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
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Secondary ID [1]
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NTX/12/06/051
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Universal Trial Number (UTN)
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Trial acronym
PICTOR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Pancreatitis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Patient-controlled oral refeeding - Patients will be allowed to drink and eat hospital food freely as tolerated.
No intervention: Conventional management -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Oral food intolerance
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Assessment method [1]
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Timepoint [1]
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Secondary outcome [1]
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Time from admission until tolerance of oral food
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Assessment method [1]
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Timepoint [1]
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Secondary outcome [2]
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Total length of hospital stay
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Assessment method [2]
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Timepoint [2]
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Secondary outcome [3]
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Need for opiates
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Assessment method [3]
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Need for opiates is defined when one (or more) of the following has been administered:
* Codeine phosphate
* Fentanyl
* Morphine, Sevredol, Meslon
* Oxynorm, Oxycodone
* Tramadol
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Timepoint [3]
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Secondary outcome [4]
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Change in pain intensity
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Assessment method [4]
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Timepoint [4]
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Baseline and 24, 48, 72h after randomisation
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Secondary outcome [5]
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Progression of acute pancreatitis severity
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Assessment method [5]
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To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
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Timepoint [5]
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Secondary outcome [6]
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Hospital readmission
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Assessment method [6]
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Timepoint [6]
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2 weeks after hospital discharge
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Secondary outcome [7]
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Local and systemic complications
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Assessment method [7]
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To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
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Timepoint [7]
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Secondary outcome [8]
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Number and type of interventions during hospital stay
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Assessment method [8]
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Timepoint [8]
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Secondary outcome [9]
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Time from admission until first flatus
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Assessment method [9]
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Timepoint [9]
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Participants will be followed for the duration of hospital stay, an expected average of 7 days
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Secondary outcome [10]
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Change in blood glucose
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Assessment method [10]
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Timepoint [10]
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Baseline and 24, 48, 72h after randomisation
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Secondary outcome [11]
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Change in plasma C-reactive protein
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Assessment method [11]
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Timepoint [11]
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Baseline and 24, 48, 72h after randomisation
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Eligibility
Key inclusion criteria
* diagnosis of acute pancreatitis
* age > 18 years
* written informed consent
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* ongoing need for opiates
* >96 hours after onset of symptoms
* chronic pancreatitis
* post-ERCP pancreatitis
* intraoperative diagnosis
* pregnancy
* malignancy
* received nutrition before randomisation
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2019
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Sample size
Target
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Accrual to date
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Final
56
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The first step in treating patients with acute pancreatitis is to provide pain relief and intravenous fluids to keep them comfortable. As the pain subsides and patient starts to feel better food and fluids by mouth are restarted. This is done to rest the pancreas which is the organ that has been inflamed. In some patients when food by mouth restarts they have pain and as a consequence they have a longer stay in hospital. It is thought that patients who have little pain and are within 24 hours of admission to hospital do well if they control their own food intake. This is in contrast to the usual treatment where the treating team advise when eating should restart.
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Trial website
https://clinicaltrials.gov/study/NCT01728896
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01728896
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