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Evaluation of Immunonutrition For Patients With Pneumonia in the Intensive Care Unit.

Primary Purpose

Nutrition Poor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nutrition
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nutrition Poor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients ( >18 years) with pneumonia requiring ventilatory support either invasive mechanical ventilation or non-invasive ventilation and could be enterally or parenterally fed in the respiratory intensive care unit of Assiut University Hospitals.

A diagnosis of pneumonia will be made based on clinical data and laboratory investigation. Radiological confirmation of the diagnosis will be done.

Patients will assess using the simplified acute physiology score (SAPS II) system (4). Also we will use nutric score.

Exclusion Criteria:

  • Age less than 18 years old.
  • Patients with immunosuppressive and malignant tumours. .Patients with severe liver and kidney disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    control

    case

    Arm Description

    included 51 patients who will receive Standard of nutrition Care (2.0 g/kg body weight/day(A I) Calories should be in range of 25-30 Kcal/kg body weight/day.

    included 51 patients who will receive adjusted and calculated dose of omega-3 polyunsaturated fatty acids (PUFA) and anti-oxidants.

    Outcomes

    Primary Outcome Measures

    Effect of immunonutrition on : - Duration of mechanical ventilation.
    Effect of immunonutrition on : Duration of mechanical ventilation.

    Secondary Outcome Measures

    Effect of immunonutrition on : - Blood oxygenation (PaO2/FiO2 ratio).
    Effect of immunonutrition on : - Blood oxygenation (PaO2/FiO2 ratio).

    Full Information

    First Posted
    June 19, 2022
    Last Updated
    July 18, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05463458
    Brief Title
    Evaluation of Immunonutrition For Patients With Pneumonia in the Intensive Care Unit.
    Official Title
    Evaluation of Immunonutrition For Patients With Pneumonia in the Intensive Care Unit.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    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
    The aim of the work will be to assess the combined effect of enteral or parenteral nutrition enriched with immunonutrition on the outcome of critically ill patients with pneumonia in comparison with patients who received standard care of nutrition in intensive care unit.
    Detailed Description
    Pneumonia is defined as an infection process of the lung parenchyma, which results from the invasion and overgrowth of microorganisms, breaking down defences, and provoking intra-alveolar exudates. Patients with pneumonia become malnourished ,exhibit declining health and changes in weight loss, and impair respiratory muscle contractility. Adequate nutrition aids respiratory muscle function and immune defence mechanisms. Therefore, the major role of nutrition in pneumonia is reducing malnutrition that induces high mortality and morbidity and maintaining impaired respiratory muscle contractility. Pulmonary failure is associated with increased catabolism and decreased gut absorption. If respiratory failure require mechanical ventilation or patient need non-invasive ventilation. The presence of an artificial airway prevents volitional nutrition intake, leading to an energy deficit, the underlying process leading to respiratory failure may induce protein catabolism, causing loss of diaphragmatic and intercostal muscle mass, impairing immunity, impairing wound healing, and increasing the risk for new infection. Nutrition support also protects patients by minimizing malnutrition and loss of lean body mass. Immunonutrition refers to modulation of the immune system provided by specific interventions that modify dietary nutrients. Several specialized enteral and parenteral formulas with immunonutrients are currently available on the market. These primarily consist of a combination of antioxidant vitamins (eg, vitamin C, vitamin E, ß-carotene), trace elements (eg, selenium, zinc), essential amino acids (eg, glutamine, arginine)or essential fatty acids, such as omega-3 fatty acids (eg, eicosapentaenoic acid, docosahexaenoic acid), and Ƴ-linolenic acid.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nutrition Poor

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    Placebo Comparator
    Arm Description
    included 51 patients who will receive Standard of nutrition Care (2.0 g/kg body weight/day(A I) Calories should be in range of 25-30 Kcal/kg body weight/day.
    Arm Title
    case
    Arm Type
    Experimental
    Arm Description
    included 51 patients who will receive adjusted and calculated dose of omega-3 polyunsaturated fatty acids (PUFA) and anti-oxidants.
    Intervention Type
    Other
    Intervention Name(s)
    nutrition
    Intervention Description
    Standard of nutrition Care plus adjusted and calculated dose of omega-3 polyunsaturated fatty acids (PUFA) anti-oxidants.
    Primary Outcome Measure Information:
    Title
    Effect of immunonutrition on : - Duration of mechanical ventilation.
    Description
    Effect of immunonutrition on : Duration of mechanical ventilation.
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    Effect of immunonutrition on : - Blood oxygenation (PaO2/FiO2 ratio).
    Description
    Effect of immunonutrition on : - Blood oxygenation (PaO2/FiO2 ratio).
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients ( >18 years) with pneumonia requiring ventilatory support either invasive mechanical ventilation or non-invasive ventilation and could be enterally or parenterally fed in the respiratory intensive care unit of Assiut University Hospitals. A diagnosis of pneumonia will be made based on clinical data and laboratory investigation. Radiological confirmation of the diagnosis will be done. Patients will assess using the simplified acute physiology score (SAPS II) system (4). Also we will use nutric score. Exclusion Criteria: Age less than 18 years old. Patients with immunosuppressive and malignant tumours. .Patients with severe liver and kidney disease.

    12. IPD Sharing Statement

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