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Inmediate Feeding Tolerance in Acute Pancreatitis

Primary Purpose

Acute Pancreatitis Due to Gallstones

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TIME OF FEEDING
Sponsored by
Hospital Central "Dr. Ignacio Morones Prieto"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis Due to Gallstones focused on measuring pancreatitis, mild, biliary, referring

Eligibility Criteria

15 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Early oral feeding

    Immediate oral feeding

    Arm Description

    TIME OF FEEDING. 48 hours after pancreatitis general management is started ( liquid diet)

    TIME OF FEEDING: 8 hours of after pancreatitis general management is started (enteral formula)

    Outcomes

    Primary Outcome Measures

    Pancreatitis reactivation after oral Feeding
    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
    Pancreatitis reactivation after oral Feeding
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 2017
    Last Updated
    November 23, 2017
    Sponsor
    Hospital Central "Dr. Ignacio Morones Prieto"
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03354065
    Brief Title
    Inmediate Feeding Tolerance in Acute Pancreatitis
    Official Title
    Inmediate Feeding Tolerance in Patients With Mild and Acute Biliary Pancreatitis vs Early Feeding
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    July 1, 2017 (Actual)
    Study Completion Date
    August 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Central "Dr. Ignacio Morones Prieto"

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pancreatitis Due to Gallstones
    Keywords
    pancreatitis, mild, biliary, referring

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    blinding of the evaluator to the study group blinding of patient to study hypothesis
    Allocation
    Randomized
    Enrollment
    59 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Early oral feeding
    Arm Type
    Active Comparator
    Arm Description
    TIME OF FEEDING. 48 hours after pancreatitis general management is started ( liquid diet)
    Arm Title
    Immediate oral feeding
    Arm Type
    Experimental
    Arm Description
    TIME OF FEEDING: 8 hours of after pancreatitis general management is started (enteral formula)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    TIME OF FEEDING
    Intervention Description
    Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)
    Primary Outcome Measure Information:
    Title
    Pancreatitis reactivation after oral Feeding
    Description
    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
    Time Frame
    Measures at 24hours after the begining of the oral intake
    Title
    Pancreatitis reactivation after oral Feeding
    Description
    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
    Time Frame
    Measures at 48hours after the begining of the oral intake

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan F Hernandez
    Organizational Affiliation
    Postgraduate office at UASLP
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Inmediate Feeding Tolerance in Acute Pancreatitis

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