Clinical trial NCT01728896: Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)
Official title: A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pancreatitis
Keywords: Acute pancreatitis, nutrition
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Oral food intolerance
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcomes:
measure: Time from admission until tolerance of oral food
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Total length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Need for opiates
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Change in pain intensity
timeFrame: Baseline and 24, 48, 72h after randomisation
measure: Progression of acute pancreatitis severity
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Hospital readmission
timeFrame: 2 weeks after hospital discharge
measure: Local and systemic complications
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Number and type of interventions during hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Time from admission until first flatus
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Change in blood glucose
timeFrame: Baseline and 24, 48, 72h after randomisation
measure: Change in plasma C-reactive protein
timeFrame: Baseline and 24, 48, 72h after randomisation
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: University of Auckland; Auckland City Hospital
Study officials:
References: