Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ω-3 PUFA | Experimental | Modular low fat diet (18%) including 9% as ω-3 PUFA |
|
| Low fat enteral diet | Active Comparator | Modular low fat (18%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ω-3 PUFA | Dietary Supplement | The patients are fed as long as the clinically required with the randomly attributed enteral solution. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Non infectious complications | Any complication will be recorded during the above time frame | up to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of mechanical ventilation | Time on mechanical ventilation though an endotracheal tube (naso-tracheal or tracheostomy) | up to day 28 |
| Length of ICU and hospital stay | ICU and hospital to discharge but maximum for 28 days |
Inclusion Criteria:
- adult >16 years, burns > 15% BSA, mechanical ventilation, next of kin consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Serrana Tihista, RD | Universidad de la República Oriental del Uruguay | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro National de Quemados | Recruiting | Montevideo | Uruguay |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28153504 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002056 | Burns |
| D007239 | Infections |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D018955 | CD36 Antigens |
| ID | Term |
|---|---|
| D010980 | Platelet Membrane Glycoproteins |
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Low fat enteral diet | Dietary Supplement | The patients are fed as long as the clinically required with the randomly attributed enteral solution |
|
|
| up to day 28 |
| Mortality | Hospital stay |
| Magnitude of CRP increase | C-reactive protein as determined for clinical purpose, Temperature (maximal T° per day), Leucocytes | during ICU stay and up to day 28 |
| D002241 |
| Carbohydrates |
| D050612 | Fatty Acid Transport Proteins |
| D026901 | Membrane Transport Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008565 | Membrane Proteins |
| D011956 | Receptors, Cell Surface |
| D011971 | Receptors, Immunologic |
| D051122 | Scavenger Receptors, Class B |
| D051116 | Receptors, Scavenger |
| D011973 | Receptors, LDL |
| D018110 | Receptors, Lipoprotein |