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

Not Applicable

• Conditions: Burn Injury
• Interventions: Dietary Supplement: ω-3 PUFA; Dietary Supplement: Low fat enteral diet

• Registration Number: NCT02189538
• Lead Sponsor: Centro Nacional de Quemados, Uruguay

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-07-03
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-14
• Status Verified: 2016-02
• Last Update Submitted: 2017-02-14
• Last Update Posted: 2017-02-15
• Primary Completion: 2017-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ω-3 PUFA	ω-3 PUFA	Modular low fat diet (18%) including 9% as ω-3 PUFA
Low fat enteral diet	Low fat enteral diet	Modular low fat (18%)

Primary Outcome Measures

Name	Time	Method
Number of infections	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 Outcome Measures

Name	Time	Method
Non infectious complications	up to day 28	Any complication will be recorded during the above time frame

Trial Locations

Locations (1)

Centro National de Quemados; 🇺🇾 Montevideo, Uruguay