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Clinical Trials/NCT02421614
NCT02421614
Completed
Phase 2

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

Zahra Vahdat Shariatpanahi1 site in 1 country48 target enrollmentAugust 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Acute Respiratory Failure
Sponsor
Zahra Vahdat Shariatpanahi
Enrollment
48
Locations
1
Primary Endpoint
length of ventilation
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Zahra Vahdat Shariatpanahi
Responsible Party
Sponsor Investigator
Principal Investigator

Zahra Vahdat Shariatpanahi

Assistant professor

Shahid Beheshti University

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Levels of Interleukin 6 (IL-6) in patient's vein blood(10 days)
  • Levels of uric acid in patient's vein blood(10 days)
  • 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)

Study Sites (1)

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