Inmediate Feeding Tolerance in Acute Pancreatitis

November 23, 2017 updated by: David Esmer, Hospital Central "Dr. Ignacio Morones Prieto"

Inmediate Feeding Tolerance in Patients With Mild and Acute Biliary Pancreatitis vs Early Feeding

Objective: Determine tolerance of immediate oral intake (8 hours posterior to the beginning of treatment) against traditional management (early feeding at 48hr) in patients with mild acute pancreatitis of biliary origin.

Double blind, randomized clinical trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators included patients 15 - 85 years old, any sex. Diagnosis of mild acute pancreatitis according to the Ranson, APACHE II and BISAP.

Signed infromed consent to participate in the study. All participants had a hepatic and biliary ultrasound to determine the biliary etiology.

The investigators excluded patients with pancreatitis of nonbiliary etiology, pregnant, severe pancreatitis, cholangitis or choledocholithiasis demonstrated during the hospital stay or with other comorbidities.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

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

15 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients older than 15 years.

  • Patients with a diagnosis of mild acute pancreatitis biliary.
  • Patients who agree to enter the protocol.

Exclusion Criteria:

  • Patients managed at another institution.

    • Patients with a diagnosis of pancreatitis of non-biliary etiology.
    • Patients with heart disease or lung disease.
    • Patients with organic failure.
    • Patients with pregnancy.
    • Patients with cholangitis.

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early oral feeding
TIME OF FEEDING. 48 hours after pancreatitis general management is started ( liquid diet)
Dietary supplement: TIME OF FEEDING
Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)
Experimental: Immediate oral feeding
TIME OF FEEDING: 8 hours of after pancreatitis general management is started (enteral formula)
Dietary supplement: TIME OF FEEDING
Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatitis reactivation after oral Feeding
Time Frame: Measures at 24hours after the begining of the oral intake
Resurgence of characteristically epigastric tansfictive pain, irradiated to the left, upper quadrant region after beginning the oral intake, systemic inflammatory response syndrome ( C reactive protein) or Significant leucocyte elevation
Measures at 24hours after the begining of the oral intake
Pancreatitis reactivation after oral Feeding
Time Frame: Measures at 48hours after the begining of the oral intake
Resurgence of characteristically epigastric tansfictive pain, irradiated to the left, upper quadrant region after beginning the oral intake, systemic inflammatory response syndrome ( C reactive protein) or Significant leucocyte elevation
Measures at 48hours after the begining of the oral intake

Collaborators and Investigators

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

Sponsor

Hospital Central "Dr. Ignacio Morones Prieto"

Investigators

  • Study Chair: Juan F Hernandez, Postgraduate office at UASLP

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)

January 1, 2017

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

October 27, 2017

First Submitted That Met QC Criteria

November 23, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 23, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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