Clinical trial NCT02189538: Effect of n-3 PUFA From Fish in Enteral Nutrition of Major Burn Patients
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burn Injury
Keywords: Infections, Enteral nutrition, SIRS, critically ill
Lead sponsor: Centro Nacional de Quemados, Uruguay
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of infections
timeFrame: up to Day 28 after burn injury
Secondary outcomes:
measure: Non infectious complications
timeFrame: up to day 28
Other outcomes:
measure: Duration of mechanical ventilation
timeFrame: up to day 28
measure: Length of ICU and hospital stay
timeFrame: up to day 28
measure: Mortality
timeFrame: Hospital stay
measure: Magnitude of CRP increase
timeFrame: during ICU stay and up to day 28
Locations:
city: Montevideo
country: Uruguay
facility: Centro National de Quemados
Study officials:
affiliation: Universidad de la República Oriental del Uruguay
name: Serrana Tihista, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tihista S, Echavarria E. Effect of omega 3 polyunsaturated fatty acids derived from fish oil in major burn patients: A prospective randomized controlled pilot trial. Clin Nutr. 2018 Feb;37(1):107-112. doi: 10.1016/j.clnu.2017.01.002. Epub 2017 Jan 16.