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

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ClinicalTrials.gov Identifier: NCT01728896
Recruitment Status : Unknown
Verified January 2013 by Max Petrov, University of Auckland, New Zealand.
Recruitment status was:  Recruiting
First Posted : November 20, 2012
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):
Max Petrov, University of Auckland, New Zealand

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.


Condition or disease Intervention/treatment Phase
Acute Pancreatitis Other: Patient-controlled oral refeeding Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
Study Start Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: Patient-controlled oral refeeding
Patients will be allowed to drink and eat hospital food freely as tolerated.
Other: Patient-controlled oral refeeding
No Intervention: Conventional management



Primary Outcome Measures :
  1. Oral food intolerance [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Total length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
  3. Need for opiates [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]

    Need for opiates is defined when one (or more) of the following has been administered:

    • Codeine phosphate
    • Fentanyl
    • Morphine, Sevredol, Meslon
    • Oxynorm, Oxycodone
    • Tramadol

  4. Change in pain intensity [ Time Frame: Baseline and 24, 48, 72h after randomisation ]
  5. Progression of acute pancreatitis severity [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
    To be defined according to the 2012 determinant-based classification of acute pancreatitis severity

  6. Hospital readmission [ Time Frame: 2 weeks after hospital discharge ]
  7. Local and systemic complications [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
    To be defined according to the 2012 determinant-based classification of acute pancreatitis severity

  8. 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 ]
  9. Time from admission until first flatus [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]
  10. Change in blood glucose [ Time Frame: Baseline and 24, 48, 72h after randomisation ]
  11. Change in plasma C-reactive protein [ Time Frame: Baseline and 24, 48, 72h after randomisation ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01728896


Locations
New Zealand
University of Auckland; Auckland City Hospital Recruiting
Auckland, New Zealand
Contact: Max S Petrov, MD, MPH, PhD       max.petrov@gmail.com   
Principal Investigator: Max S Petrov, MD, MPH, PhD         
Sponsors and Collaborators
University of Auckland, New Zealand

Responsible Party: Max Petrov, Prinicpal Investigator Dr. Max Petrov, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT01728896     History of Changes
Other Study ID Numbers: NTX/12/06/051
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Max Petrov, University of Auckland, New Zealand:
Acute pancreatitis, nutrition

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases