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Enteral Feeding Composition and Acute Respiratory Failure

Primary Purpose

Acute Respiratory Failure

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
high-protein low-carbohydrate diet with high olive oil
high-protein low-carbohydrate diet with high sunflower oil
Sponsored by
Zahra Vahdat Shariatpanahi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Respiratory Failure focused on measuring acute respiratory failure, lung, enteral feeding, feeding composition, olive, high fat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of Nutrition Sciences and Food Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

high olive oli

high sunflower oil

kitchen formula

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

length of ventilation
The number of days from the patient intubation to his/her extubation

Secondary Outcome Measures

Levels of high sensitive C-Reactive Protein (hs-CRP) in patient's vein blood
Levels of Total Antioxidant Capacity (TAC) in patient's vein blood
Levels of uric acid in patient's vein blood
Levels of Interleukin 6 (IL-6) in patient's vein blood

Full Information

First Posted
April 7, 2015
Last Updated
March 21, 2016
Sponsor
Zahra Vahdat Shariatpanahi
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1. Study Identification

Unique Protocol Identification Number
NCT02421614
Brief Title
Enteral Feeding Composition and Acute Respiratory Failure
Official Title
Effect of Enteral Feeding's Macronutrient Composition on Inflammatory Mediators, Oxidative Stress and Outcomes in Intensive Care Unit Patients With Acute Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zahra Vahdat Shariatpanahi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
Keywords
acute respiratory failure, lung, enteral feeding, feeding composition, olive, high fat

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high olive oli
Arm Type
Experimental
Arm Description
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.
Arm Title
high sunflower oil
Arm Type
Experimental
Arm Description
A high fat (45%) low carbohydrate (35%) enteral feeding will be administered to acute respiratory failure patients. The total fat will be sunflower oil.
Arm Title
kitchen formula
Arm Type
No Intervention
Arm Description
A high protein kitchen diet for tube feeding will be administered to acute respiratory failure patients.
Intervention Type
Other
Intervention Name(s)
high-protein low-carbohydrate diet with high olive oil
Intervention Type
Other
Intervention Name(s)
high-protein low-carbohydrate diet with high sunflower oil
Primary Outcome Measure Information:
Title
length of ventilation
Description
The number of days from the patient intubation to his/her extubation
Time Frame
The number of days at least 3, to which days that patient extubated
Secondary Outcome Measure Information:
Title
Levels of high sensitive C-Reactive Protein (hs-CRP) in patient's vein blood
Time Frame
10 days
Title
Levels of Total Antioxidant Capacity (TAC) in patient's vein blood
Time Frame
10 days
Title
Levels of uric acid in patient's vein blood
Time Frame
10 days
Title
Levels of Interleukin 6 (IL-6) in patient's vein blood
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Nutrition Sciences and Food Technology
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Enteral Feeding Composition and Acute Respiratory Failure

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