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

Burn Injury Clinical Trial

— OmegaBurn  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02189538
• Other study ID #: Universidad de la República
• Status: Recruiting
• Phase: N/A
• First received: July 3, 2014
• Last updated: February 14, 2017
• Start date: January 2013
• Est. completion date: February 2018

Study information

• Verified date: February 2016
• Source: Centro Nacional de Quemados, Uruguay
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Injury
• Burns

Intervention

Dietary Supplement:
• ?-3 PUFA
The patients are fed as long as the clinically required with the randomly attributed enteral solution.
• Low fat enteral diet
The patients are fed as long as the clinically required with the randomly attributed enteral solution

Locations

Country	Name	City	State
Uruguay	Centro National de Quemados	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
Centro Nacional de Quemados, Uruguay

Country where clinical trial is conducted

Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of mechanical ventilation	Time on mechanical ventilation though an endotracheal tube (naso-tracheal or tracheostomy)	up to day 28
Other	Length of ICU and hospital stay	ICU and hospital to discharge but maximum for 28 days	up to day 28
Other	Mortality		Hospital stay
Other	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
Primary	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	Non infectious complications	Any complication will be recorded during the above time frame	up to day 28