Patient-Initiated and ConTrolled Oral Refeeding (PICTOR) | NCT01728896

Studies
Patient-Initiated and ConTrolled Oral Refeeding (PICTOR)

NCT01728896

Sponsor

University of Auckland, New Zealand

Status

Completed

Last Update Posted

Sep 26, 2019Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Acute Pancreatitis

Interventions

Patient-controlled oral refeeding

Countries

New Zealand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2013Actual

Primary Completion Date

Jun 1, 2018Actual

Completion Date

Jun 1, 2019Actual

First Submitted Date

Nov 5, 2012

First Submission Date that Met QC Criteria

Nov 13, 2012

First Posted Date

Nov 20, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2019

Last Update Posted Date

Sep 26, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Max Petrov, Prinicpal Investigator Dr. Max Petrov, University of Auckland, New ZealandPrincipal Investigator

Lead Sponsor

University of Auckland, New ZealandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient-controlled oral refeeding	Experimental	Patients will be allowed to drink and eat hospital food freely as tolerated.	Other: Patient-controlled oral refeeding
Conventional management	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patient-controlled oral refeeding	Other		Patient-controlled oral refeeding

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Time from admission until tolerance of oral food		Participants will be followed for the duration of hospital stay, an expected average of 7 days
Total length of hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 7 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Auckland; Auckland City Hospital		Auckland			New Zealand

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided