Enteral Feeding Composition and Acute Respiratory Failure

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02421614

Enrollment

Registered

2015-04-20

Start date

2013-08-31

Completion date

2015-12-31

Last updated

2016-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

acute respiratory failure, lung, enteral feeding, feeding composition, olive, high fat

Brief summary

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.

Interventions

OTHERhigh-protein low-carbohydrate diet with high olive oil

OTHERhigh-protein low-carbohydrate diet with high sunflower oil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026