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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Burn Injury

Intervention / Treatment
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* Dietary Supplement: ω-3 PUFA
* Dietary Supplement: Low fat enteral diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ω-3 PUFA<br>Modular low fat diet (18%) including 9% as ω-3 PUFA | Dietary Supplement: ω-3 PUFA<br>* The patients are fed as long as the clinically required with the randomly attributed enteral solution.<br>* Other names: modular preparation: 9% ω-3 of the total 18% fat;|
| Active Comparator: Low fat enteral diet<br>Modular low fat (18%) | Dietary Supplement: Low fat enteral diet<br>* The patients are fed as long as the clinically required with the randomly attributed enteral solution<br>* Other names: modular diet;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non infectious complications | Any complication will be recorded during the above time frame | up to day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infections, Enteral nutrition, SIRS, critically ill