Effect of n-3 PUFA From Fish in Enteral Nutrition of Major Burn Patients

Overview

Studies have shown that burn patients may benefit from low fat diets, but there is still no strong data regarding the impact of fatty acid composition used for feeding. The trial test the hypothesis that the inclusion of omega-3 PUFA in a low fat diet may improve outcome. Prospective randomised controlled trial in adult patients admitted for burns > 15% body surface area (BSA), and inhalation injury requiring mechanical ventilation and enteral nutrition. On admission randomization to receive a low-fat (18% energy as fat) modular enteral diet (LF-EN) and identical with the half of fat provided by fish oil (FO-EN). Study endpoints: mechanical ventilation time, inflammation (CRP), infectious and other complications, mortality until discharge.

The study is planed as 2 parts: 1) preliminary study testing the feasibility of the study, 2) the study completed with information from the preliminary phase, both phases being randomised and controlled.

Full Title of Study: “Effect of Omega-3 PUFA From Fish in Major Burn Patients. EFECTO DE ÁCIDOS GRASOS POLIINSATURADOS OMEGA 3 DERIVADOS DE ACEITE DE PESCADO, EN QUEMADOS GRAVES”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2017

Detailed Description

Randomisation within the first 24 hours of admission to 2 types of enteral feeds: 1) ω 3 PUFA (FO-EN) or 2) control solution which is the hospitals standard low 18% fat containing solution.

The patients are fed as long as clinically required with the initial solution.

Interventions

  • Dietary Supplement: ω-3 PUFA
    • The patients are fed as long as the clinically required with the randomly attributed enteral solution.
  • Dietary Supplement: Low fat enteral diet
    • The patients are fed as long as the clinically required with the randomly attributed enteral solution

Arms, Groups and Cohorts

  • Experimental: ω-3 PUFA
    • Modular low fat diet (18%) including 9% as ω-3 PUFA
  • Active Comparator: Low fat enteral diet
    • Modular low fat (18%)

Clinical Trial Outcome Measures

Primary Measures

  • Number of infections
    • Time Frame: up to Day 28 after burn injury
    • Infectious complications will be recorded according to CDC criteria, and grouped as pulmonary, blood stream infections (catheter related or not), cutaneous, abdominal and others

Secondary Measures

  • Non infectious complications
    • Time Frame: up to day 28
    • Any complication will be recorded during the above time frame

Participating in This Clinical Trial

Inclusion Criteria

  • adult >16 years, burns > 15% BSA, mechanical ventilation, next of kin consent

Exclusion Criteria

  • absence of the above, absence of commitment to full treatment
  • comorbidities (cancer, COPD, diabetes, liver failure (Child Pugh B and C)
  • pregnancy

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centro Nacional de Quemados, Uruguay
  • Provider of Information About this Clinical Study
    • Principal Investigator: Serrana Tihista, dietitian – Centro Nacional de Quemados, Uruguay
  • Overall Official(s)
    • Serrana Tihista, RD, Principal Investigator, Universidad de la República Oriental del Uruguay

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