Enteral Feeding Composition and Acute Respiratory Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-12-31

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.

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Detailed Description

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Conditions

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Acute Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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high olive oli

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.

Group Type EXPERIMENTAL

high-protein low-carbohydrate diet with high olive oil

Intervention Type OTHER

high sunflower oil

A high fat (45%) low carbohydrate (35%) enteral feeding will be administered to acute respiratory failure patients. The total fat will be sunflower oil.

Group Type EXPERIMENTAL

high-protein low-carbohydrate diet with high sunflower oil

Intervention Type OTHER

kitchen formula

A high protein kitchen diet for tube feeding will be administered to acute respiratory failure patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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high-protein low-carbohydrate diet with high olive oil

Intervention Type OTHER

high-protein low-carbohydrate diet with high sunflower oil

Intervention Type OTHER

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