A Randomized Controlled Trial of Patient-Initiated and ConTrolled Oral Refeeding in Acute Pancreatitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Oral food intolerance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patient-controlled oral refeeding
Patients will be allowed to drink and eat hospital food freely as tolerated.
Intervention: Patient-controlled oral refeeding (Other)
Conventional management
Outcomes
Primary Outcomes
Oral food intolerance
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary Outcomes
- Time from admission until tolerance of oral food(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Change in plasma C-reactive protein(Baseline and 24, 48, 72h after randomisation)
- Need for opiates(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Hospital readmission(2 weeks after hospital discharge)
- Total length of hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Change in pain intensity(Baseline and 24, 48, 72h after randomisation)
- Progression of acute pancreatitis severity(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Local and systemic complications(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Time from admission until first flatus(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
- Change in blood glucose(Baseline and 24, 48, 72h after randomisation)
- Number and type of interventions during hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
Investigators
Max Petrov
Prinicpal Investigator Dr. Max Petrov
University of Auckland, New Zealand