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Enteral Nutrition in Acute Generalized Peritonitis (PAG/NUTRI)

Primary Purpose

Enteral and Supplement Feeds Adverse Reaction, Peritonitis; Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
study group
Sponsored by
Université Evangélique enAfrique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Enteral and Supplement Feeds Adverse Reaction

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patient operated for peritonitis with intestinal suture during treatment have a q-SOFA score of 1 to 2 surgeon's agreement to enteral feeding at risk of malnutrition (BMC) Exclusion Criteria: q SOFA score > 2 patients with tare (diabetes, HIV, renal failure)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    study group

    control group

    Arm Description

    an intervention arm consisting of patients who will receive the locally manufactured protein-energy ration after a laparotomy indicated for generalized acute peritonitis

    patients who will receive the commercially available protein-energy ration after a laparotomy indicated for generalized acute peritonitis

    Outcomes

    Primary Outcome Measures

    Tolerability of feeding
    We will screen complications after feeding

    Secondary Outcome Measures

    nutritional surveillance
    changes in nutritional status using body mass index, albumin measurement, anthropometric data

    Full Information

    First Posted
    August 7, 2023
    Last Updated
    August 11, 2023
    Sponsor
    Université Evangélique enAfrique
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05997745
    Brief Title
    Enteral Nutrition in Acute Generalized Peritonitis
    Acronym
    PAG/NUTRI
    Official Title
    Effects of Early Enteral Nutrition With a Locally Produced Protein-energy Ration Versus a Marketed Nutritional Solution in Patients Operated on for Acute Generalized Peritonitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 20, 2023 (Anticipated)
    Primary Completion Date
    October 30, 2023 (Anticipated)
    Study Completion Date
    October 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Université Evangélique enAfrique

    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
    Hospitals in South Kivu always have problems supplying artificial enteral nutritional products because of their high cost and low availability in our areas. While the Province has cereals, knowing their nutritional composition would enable the formulation of a nutritional product based on local protein-energy products. Hence the questions below: Can a local cereal-based protein-energy ration be used instead of a costly imported artificial nutritional solution to improve the nutritional status of patients operated on for PAG? What is the tolerance of this early enteral nutrition on the healing and functional recovery of patients compared with an artificial nutritional solution? To answer these questions, a randomized clinical trial has been designed with the following objectives: To formulate an enteral diet using cereals available in our environment with a protein-calorie composition superimposable on the artificial enteral ration, Evaluate the tolerance and advantages of early enteral nutrition with a locally manufactured protein-caloric ration vs. a commercially available artificial nutritional solution in patients undergoing surgery for PAG.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Enteral and Supplement Feeds Adverse Reaction, Peritonitis; Acute

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Description
    an intervention arm consisting of patients who will receive the locally manufactured protein-energy ration after a laparotomy indicated for generalized acute peritonitis
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    patients who will receive the commercially available protein-energy ration after a laparotomy indicated for generalized acute peritonitis
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    study group
    Intervention Description
    Patients will receive early enteral locally nutrition postoperatively following surgery for peritonitis
    Primary Outcome Measure Information:
    Title
    Tolerability of feeding
    Description
    We will screen complications after feeding
    Time Frame
    10 days after surgery
    Secondary Outcome Measure Information:
    Title
    nutritional surveillance
    Description
    changes in nutritional status using body mass index, albumin measurement, anthropometric data
    Time Frame
    2 days after, 5 days after, 10 days after feeding

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient operated for peritonitis with intestinal suture during treatment have a q-SOFA score of 1 to 2 surgeon's agreement to enteral feeding at risk of malnutrition (BMC) Exclusion Criteria: q SOFA score > 2 patients with tare (diabetes, HIV, renal failure)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    JEAN PAUL CIKWANINE, MASTER
    Phone
    +243990860491
    Email
    jpcikwa1@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Enteral Nutrition in Acute Generalized Peritonitis

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