Nutrition PoorNCT05463458
Evaluation of Immunonutrition For Patients With Pneumonia in the Intensive Care Unit.
A study testing nutrition in people with Nutrition Poor, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition Poor
- What is being tested?
- nutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age less than 18 years old.
- Patients with immunosuppressive and malignant tumours. .Patients with severe liver and kidney disease.
About this study
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.
Read the 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.
- Conditions
- Nutrition Poor
- Being tested
- nutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritionOther
Standard of nutrition Care plus adjusted and calculated dose of omega-3 polyunsaturated fatty acids (PUFA) anti-oxidants.
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | 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. Receives: Other: nutrition |
| case | Experimental | included 51 patients who will receive adjusted and calculated dose of omega-3 polyunsaturated fatty acids (PUFA) and anti-oxidants. Receives: Other: nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of immunonutrition on : - Duration of mechanical ventilation.
Effect of immunonutrition on :
- Duration of mechanical ventilation.
Measured: 14 days
Secondary outcomes (1)
Effect of immunonutrition on : - Blood oxygenation (PaO2/FiO2 ratio).
Effect of immunonutrition on :
- Blood oxygenation (PaO2/FiO2 ratio).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition PoorStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Azza Bahaa El-Din Ali Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463458
- Sponsor's protocol ID
- nutrition in ICU
- Status last verified
- Jul 2022
- First submitted
- 19 Jun 2022
- Last updated
- 20 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunonutrition For Patients With Pneumonia in the Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT05463458
- Acronym / sponsor ID
- nutrition in ICU
- Conditions
- Nutrition Poor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: nutritionincluded 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 | Experimental | Other: nutritionincluded 51 patients who will receive adjusted and calculated dose of omega-3 polyunsaturated fatty acids (PUFA) and anti-oxidants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Age less than 18 years old.
- Patients with immunosuppressive and malignant tumours. .Patients with severe liver and kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritionStandard of nutrition Care plus adjusted and calculated dose of omega-3 polyunsaturated fatty acids (PUFA) anti-oxidants. | Other | case, control |
Primary outcome
Effect of immunonutrition on : - Duration of mechanical ventilation.
Time frame: 14 days
Effect of immunonutrition on : * Duration of mechanical ventilation.
1 secondary outcome
Effect of immunonutrition on : - Blood oxygenation (PaO2/FiO2 ratio).
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing nutrition in people with Nutrition Poor, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of immunonutrition on : - Duration of mechanical ventilation. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.