Burn Injury
Conditions
Keywords
Infections, Enteral nutrition, SIRS, critically ill
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.
Interventions
DIETARY_SUPPLEMENTω-3 PUFA
The patients are fed as long as the clinically required with the randomly attributed enteral solution.
DIETARY_SUPPLEMENTLow fat enteral diet
The patients are fed as long as the clinically required with the randomly attributed enteral solution
Sponsors
Centro Nacional de Quemados, Uruguay
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Non infectious complications | up to day 28 | Any complication will be recorded during the above time frame |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of mechanical ventilation | up to day 28 | Time on mechanical ventilation though an endotracheal tube (naso-tracheal or tracheostomy) |
| Length of ICU and hospital stay | up to day 28 | ICU and hospital to discharge but maximum for 28 days |
| Mortality | Hospital stay | — |
| Magnitude of CRP increase | during ICU stay and up to day 28 | C-reactive protein as determined for clinical purpose, Temperature (maximal T° per day), Leucocytes |
Countries
Uruguay
Outcome results
None listed