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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)
Scientific title
A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
Secondary ID [1] 0 0
NTX/12/06/051
Universal Trial Number (UTN)
Trial acronym
PICTOR
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
Experimental: Patient-controlled oral refeeding - Patients will be allowed to drink and eat hospital food freely as tolerated.

No intervention: Conventional management -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Oral food intolerance
Timepoint [1] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [1] 0 0
Time from admission until tolerance of oral food
Timepoint [1] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [2] 0 0
Total length of hospital stay
Timepoint [2] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [3] 0 0
Need for opiates
Timepoint [3] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [4] 0 0
Change in pain intensity
Timepoint [4] 0 0
Baseline and 24, 48, 72h after randomisation
Secondary outcome [5] 0 0
Progression of acute pancreatitis severity
Timepoint [5] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [6] 0 0
Hospital readmission
Timepoint [6] 0 0
2 weeks after hospital discharge
Secondary outcome [7] 0 0
Local and systemic complications
Timepoint [7] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [8] 0 0
Number and type of interventions during hospital stay
Timepoint [8] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [9] 0 0
Time from admission until first flatus
Timepoint [9] 0 0
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcome [10] 0 0
Change in blood glucose
Timepoint [10] 0 0
Baseline and 24, 48, 72h after randomisation
Secondary outcome [11] 0 0
Change in plasma C-reactive protein
Timepoint [11] 0 0
Baseline and 24, 48, 72h after randomisation

Eligibility
Key inclusion criteria
* diagnosis of acute pancreatitis
* age > 18 years
* written informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2019
Sample size
Target
Accrual to date
Final
56
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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

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