Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)

Not Applicable

Completed

• Conditions: Acute Pancreatitis
• Interventions: Other: Patient-controlled oral refeeding

• Registration Number: NCT01728896
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2012-11-13
• Study First Posted: 2012-11-20
• Study Start: 2013-12-01
• Primary Completion: 2018-06-01
• Study Completion: 2019-06-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient-controlled oral refeeding	Patient-controlled oral refeeding	Patients will be allowed to drink and eat hospital food freely as tolerated.

Primary Outcome Measures

Name	Time	Method
Oral food intolerance	Participants will be followed for the duration of hospital stay, an expected average of 7 days

Secondary Outcome Measures

Name	Time	Method
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	Need for opiates is defined when one (or more) of the following has been administered: * Codeine phosphate; * Fentanyl; * Morphine, Sevredol, Meslon; * Oxynorm, Oxycodone; * Tramadol
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	To be defined according to the 2012 determinant-based classification of acute pancreatitis severity
Local and systemic complications	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
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

Trial Locations

Locations (1)

University of Auckland; Auckland City Hospital; 🇳🇿 Auckland, New Zealand