Evaluation of Immunonutrition For Patients With Pneumonia in the Intensive Care Unit.
1 other identifier
interventional
102
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2022
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 19, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedJuly 20, 2022
July 1, 2022
1.8 years
June 19, 2022
July 18, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of immunonutrition on : - Duration of mechanical ventilation.
Effect of immunonutrition on : * Duration of mechanical ventilation.
14 days
Secondary Outcomes (1)
Effect of immunonutrition on : - Blood oxygenation (PaO2/FiO2 ratio).
14 days
Study Arms (2)
control
PLACEBO COMPARATORincluded 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.
case
EXPERIMENTALincluded 51 patients who will receive adjusted and calculated dose of omega-3 polyunsaturated fatty acids (PUFA) and anti-oxidants.
Interventions
Standard of nutrition Care plus adjusted and calculated dose of omega-3 polyunsaturated fatty acids (PUFA) anti-oxidants.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Age less than 18 years old.
- Patients with immunosuppressive and malignant tumours. .Patients with severe liver and kidney disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 19, 2022
First Posted
July 19, 2022
Study Start
September 1, 2022
Primary Completion
July 1, 2024
Study Completion
September 1, 2024
Last Updated
July 20, 2022
Record last verified: 2022-07