Enteral Feeding Composition and Acute Respiratory Failure

Acute Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421614
• Other study ID #: 054575
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 7, 2015
• Last updated: March 21, 2016
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Other:
• high-protein low-carbohydrate diet with high olive oil

• high-protein low-carbohydrate diet with high sunflower oil

Locations

Country	Name	City	State
Iran, Islamic Republic of	Faculty of Nutrition Sciences and Food Technology	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Zahra Vahdat Shariatpanahi

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of ventilation	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	No
Secondary	Levels of high sensitive C-Reactive Protein (hs-CRP) in patient's vein blood		10 days	No
Secondary	Levels of Total Antioxidant Capacity (TAC) in patient's vein blood		10 days	No
Secondary	Levels of uric acid in patient's vein blood		10 days	No
Secondary	Levels of Interleukin 6 (IL-6) in patient's vein blood		10 days	No