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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05463458
Collaborator
(none)
102
2
24

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: nutrition
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of Immunonutrition For Patients With Pneumonia in the Intensive Care Unit.
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: control

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.

Other: nutrition
Standard of nutrition Care plus adjusted and calculated dose of omega-3 polyunsaturated fatty acids (PUFA) anti-oxidants.

Experimental: case

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

Other: nutrition
Standard of nutrition Care plus adjusted and calculated dose of omega-3 polyunsaturated fatty acids (PUFA) anti-oxidants.

Outcome Measures

Primary Outcome Measures

  1. Effect of immunonutrition on : - Duration of mechanical ventilation. [14 days]

    Effect of immunonutrition on : Duration of mechanical ventilation.

Secondary Outcome Measures

  1. Effect of immunonutrition on : - Blood oxygenation (PaO2/FiO2 ratio). [14 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Azza Bahaa El-Din Ali Mohamed, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05463458
Other Study ID Numbers:
  • nutrition in ICU
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022