Skip to main content
OpenTrials
Completed

NCT Number: NCT02421614

Enteral Feeding Composition and 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Nutrition Sciences and Food Technology

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high-protein low-carbohydrate diet with high olive oil

Other

high-protein low-carbohydrate diet with high sunflower oil

Other

Primary outcomes

  1. 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

  1. Levels of high sensitive C-Reactive Protein (hs-CRP) in patient's vein blood

    Time frame: 10 days

  2. Levels of Total Antioxidant Capacity (TAC) in patient's vein blood

    Time frame: 10 days

  3. Levels of uric acid in patient's vein blood

    Time frame: 10 days

  4. Levels of Interleukin 6 (IL-6) in patient's vein blood

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Zahra Vahdat Shariatpanahi

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 20, 2015
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.