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
About this trial
This is an interventional supportive care trial for Nutrition Poor
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.
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
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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Evaluation of Immunonutrition For Patients With Pneumonia in the Intensive Care Unit.
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