Enteral Feeding Composition and Acute Respiratory Failure

March 21, 2016 updated by: Zahra Vahdat Shariatpanahi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Other: high-protein low-carbohydrate diet with high olive oil
EXPERIMENTAL: 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.
Other: high-protein low-carbohydrate diet with high sunflower oil
NO_INTERVENTION: kitchen formula
A high protein kitchen diet for tube feeding will be administered to acute respiratory failure patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of ventilation
Time Frame: 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
The number of days at least 3, to which days that patient extubated

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zahra Vahdat Shariatpanahi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (ESTIMATE)

April 20, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 054575

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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