Study of the Diet in Patients With the Diagnostic of Acute Pancreatitis (PADI)

February 1, 2019 updated by: Elena Ramírez-Maldonado, Consorci Sanitari del Garraf

Randomized Multicenter Prospective Clinical Trial to Compare the Effectiveness of Starting Early Oral Diet Versus Nil Per Oral in Patients With Acute Pancreatitis

Acute pancreatitis (AP) is a common condition in emergency services worldwide. Approximately 85% of AP are mild and the patients usually recover within 1 to 2 weeks, not requeiring any critical care and organ support. The management of mild AP conventionally involves fasting, intravenous hydration and adequate analgesia until pain improves in order to prevent stimulation and allow the pancreas gland to rest.

The current guidelines recommend the oral food intake should be tried as soon as possible, and beneficial effects or early enteral nutrition with mild AP have been reported in literature.

Then, early oral refeeding (EORF) after mild and moderate AP is beneficial, but the optimal timing and starting criteria are unclear. Even now, refeeding after mild and moderate AP is typically started until clinical symptoms have resolved and pancreatic enzymes are decreasing, in a successively increasing manner. The aim of this study is to evaluate length of hospital stay, clinical findings and complications for EORF with immediately full caloric intake in patients with mild and moderate AP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is prospective, randomized, controlled, multicentre trial. Patients with mild and moderate acute pancreatitis (AP) will be randomly in two groups: group A: with early oral refeeding (EOR) with low fat solid diet (LFSD), started from the first day of admission in the hospital, and group B: with Nil Per Oral (NPO), until the symptoms, signs, inflammatory parameters of AP have resolved.

The primary and several secondary endpoints will be obtained and EORF with LFSD will improve the following measures of outcome:

  1. Length of hospital admission (the primary endpoint)
  2. Serum amylase, lipase, electrolytes, calcium, urea, creatinine, liver function tests, C-reactive protein (biomarker of inflammation), nutritional parameters (albumin, prealbumin, cholesterol, triglycerides) and full blood count - routine blood tests performed daily until normalization of serum lipase or until discharge.
  3. Weight, at hospital admission and discharge, and at day 30 post-discharge clinic follow-up.
  4. Systemic complications including hemodynamic instability, renal failure, intensive care admission, surgery, radiological and endoscopic procedures.
  5. Pain and Analgesic requirement.
  6. Local complications including pancreatic necrosis, abscess, pseudocyst.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sant Pere De Ribes, Barcelona, Spain, 08810
        • Consorci Sanitari del Garraf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1) Diagnosed of AP by at least two of these three criteria: compatible abdominal pain, amylase or lipase level superior in three-fold respective laboratory baseline levels, and suitable findings in imaging techniques (CT, ultrasound or MRI)
  • 2) age > 18 years, sign consent form.

Exclusion Criteria:

  • 1) pregnant o breastfeeding women;
  • 2) abdominal pain lasting >96 horas before admission;
  • 3) the possibility of poor oral intake for reasons other than AP;
  • 4) Pancreatic neoplasm, endoscopic retrograde cholangiopancreatography or trauma etiology;
  • 5) Chronic pancreatitis;
  • 6) Randomization greater the 12 hours after admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Early oral refeeding

The patients will be started the oral refeeding from the first day of admission in the hospital.

Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day
Other: EARLY ORAL REFEEDING
the oral refeeding will be started after admission. Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day
NO_INTERVENTION: FASTING
The oral diet will be reintroduced in a traditional stepwise manner until the symptoms, signs, inflammatory parameters of AP have resolved

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospitalization
Time Frame: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.
Days
measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse of abdominal pain
Time Frame: measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days, and during the follow up (1 month after discharge)
Pain Scale: 0=No pain, 1=Very mild, 2=Discomforting, 3=Tolerable, 4=Distressing, 5=Distressing, 6=Intense pain, 7=Very intense pain, 8=Horrible pain, 9=Excruciating, 10=Unimaginable pain
measured from onset of admission until time of actual discharge from hospital. Assessed between 1-10 days up to 14 days, and during the follow up (1 month after discharge)
Duration of fasting
Time Frame: 2-3 days approximately since the first day of hospital admission
Days
2-3 days approximately since the first day of hospital admission
Tolerance to food
Time Frame: 2-7 days approximately during hospital admission and during the follow up
The patient's symptoms are controlled with the established treatment and the patient can eat at least 50% of the meals
2-7 days approximately during hospital admission and during the follow up
Elevation of serum amylase or lipase
Time Frame: 2-4 days approximately during hospital admission after oral refeeding, until hospital discharge
Elevation amylase or lipase level after oral refeeding
2-4 days approximately during hospital admission after oral refeeding, until hospital discharge
Intra-abdominal infection
Time Frame: 1 month
Fever: temperature greater than 38 or positive cultures of blood or pancreatic necrosis
1 month
Death
Time Frame: During hospital stay (up to 1 day)
Mortality
During hospital stay (up to 1 day)
Operation rate
Time Frame: 2 month
The rate of patients received operation for pancreatitis debridement
2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari del Garraf

Collaborators

Hospital Clinic of Barcelona
Hospital Universitari Joan XXIII de Tarragona.

Investigators

  • Principal Investigator: Elena Ramírez-Maldonado, MD, Consorcio Sanitari del Garraf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

December 31, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

January 27, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (ACTUAL)

February 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PADI_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results of this trial will be published in an open access way and disseminates among medical societies

IPD Sharing Time Frame

From June 2019 the data will be available until publication

IPD Sharing Access Criteria

Open accès publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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