Enteral Feeding Composition and Acute Respiratory Failure

Study Overview
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Brief Summary
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This study aimed to investigate the effect of enteral feeding's macronutrient composition on inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients with acute respiratory failure. In this double-blind randomized control trial, 42 patients of both sexes and diagnosed with acute respiratory failure in ICU that receive enteral feeding, will be randomly assigned to three groups of 14 each. First Intervention group; high-protein low-carbohydrate diet with high olive oil, the second intervention group; high-protein low-carbohydrate diet with high sunflower oil and control; high-protein kitchen formula. Intravenous levels of uric acid, high sensitive C-Reactive Protein (hs-CRP), Interleukin 6 (IL-6) and Total Antioxidant Capacity (TAC) measured at days 0 and 10. As well as, organ failure, duration of ventilation, length of ICU stay and mortality rates will be evaluated.

Official Title
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Effect of Enteral Feeding's Macronutrient Composition on Inflammatory Mediators, Oxidative Stress and Outcomes in Intensive Care Unit Patients With Acute Respiratory Failure

Conditions
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Acute Respiratory Failure

Intervention / Treatment
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* Other: high-protein low-carbohydrate diet with high olive oil
* Other: high-protein low-carbohydrate diet with high sunflower oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: enrolled in ICU age older than 18 years old need to be mechanically ventilation have enteral feeding no previous diabetes no previous HIV infection no previous nervous system no previous liver failure no previous nephrotic syndrome not passed more than 48 hours from diagnose of acute respiratory failure Exclusion Criteria: death at less than three days of enteral feeding administration extubation at less than three days of enteral feeding administration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high olive oli<br>A high fat (45%) low carbohydrate (35%) enteral feeding will be administered to acute respiratory failure patients. The percentage of olive oil will be half of total fat. | Other: high-protein low-carbohydrate diet with high olive oil<br> <br> |
| Experimental: high sunflower oil<br>A high fat (45%) low carbohydrate (35%) enteral feeding will be administered to acute respiratory failure patients. The total fat will be sunflower oil. | Other: high-protein low-carbohydrate diet with high sunflower oil<br> <br> |
| No Intervention: kitchen formula<br>A high protein kitchen diet for tube feeding will be administered to acute respiratory failure patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of ventilation | The number of days from the patient intubation to his/her extubation | The number of days at least 3, to which days that patient extubated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of high sensitive C-Reactive Protein (hs-CRP) in patient's vein blood |  | 10 days | 
| Levels of Total Antioxidant Capacity (TAC) in patient's vein blood |  | 10 days | 
| Levels of uric acid in patient's vein blood |  | 10 days | 
| Levels of Interleukin 6 (IL-6) in patient's vein blood |  | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute respiratory failure, lung, enteral feeding, feeding composition, olive, high fat