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Patient-Initiated and ConTrolled Oral Refeeding (PICTOR) (PICTOR)

Primary Purpose

Acute Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Patient-controlled oral refeeding
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 Acute pancreatitis, nutrition

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of acute pancreatitis
  • age > 18 years
  • written informed consent

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

Sites / Locations

  • University of Auckland; Auckland City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient-controlled oral refeeding

Conventional management

Arm Description

Patients will be allowed to drink and eat hospital food freely as tolerated.

Outcomes

Primary Outcome Measures

Oral food intolerance

Secondary Outcome Measures

Time from admission until tolerance of oral food
Total length of hospital stay
Need for opiates
Need for opiates is defined when one (or more) of the following has been administered: Codeine phosphate Fentanyl Morphine, Sevredol, Meslon Oxynorm, Oxycodone Tramadol
Change in pain intensity
Progression of acute pancreatitis severity
To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
Hospital readmission
Local and systemic complications
To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
Number and type of interventions during hospital stay
Time from admission until first flatus
Change in blood glucose
Change in plasma C-reactive protein

Full Information

First Posted
November 5, 2012
Last Updated
September 24, 2019
Sponsor
University of Auckland, New Zealand
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1. Study Identification

Unique Protocol Identification Number
NCT01728896
Brief Title
Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)
Acronym
PICTOR
Official Title
A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2013 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2019 (Actual)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
Acute pancreatitis, nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient-controlled oral refeeding
Arm Type
Experimental
Arm Description
Patients will be allowed to drink and eat hospital food freely as tolerated.
Arm Title
Conventional management
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Patient-controlled oral refeeding
Primary Outcome Measure Information:
Title
Oral food intolerance
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary Outcome Measure Information:
Title
Time from admission until tolerance of oral food
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Total length of hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Need for opiates
Description
Need for opiates is defined when one (or more) of the following has been administered: Codeine phosphate Fentanyl Morphine, Sevredol, Meslon Oxynorm, Oxycodone Tramadol
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Change in pain intensity
Time Frame
Baseline and 24, 48, 72h after randomisation
Title
Progression of acute pancreatitis severity
Description
To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Hospital readmission
Time Frame
2 weeks after hospital discharge
Title
Local and systemic complications
Description
To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Number and type of interventions during hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Time from admission until first flatus
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Change in blood glucose
Time Frame
Baseline and 24, 48, 72h after randomisation
Title
Change in plasma C-reactive protein
Time Frame
Baseline and 24, 48, 72h after randomisation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of acute pancreatitis age > 18 years written informed consent 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
Facility Information:
Facility Name
University of Auckland; Auckland City Hospital
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

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Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)

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