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

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

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.

Study Overview

• Status: Unknown
• Conditions: Burn Injury
• Intervention / Treatment: Dietary supplement: ω-3 PUFA; Dietary supplement: Low fat enteral diet

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uruguay
  • Montevideo, Uruguay
    • Recruiting
    • Centro National de Quemados
    • Contact: Serrana Tihista, RD; Phone Number: (598) 2613 35 63; Email: serranatihista@hotmail.com
    • Principal Investigator: Serrana Tihista, RD
    • Sub-Investigator: Julio Roberto Cabrera Martin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ω-3 PUFA; Modular low fat diet (18%) including 9% as ω-3 PUFA	Dietary supplement: ω-3 PUFA; The patients are fed as long as the clinically required with the randomly attributed enteral solution.; Other Names: modular preparation: 9% ω-3 of the total 18% fat
Active Comparator: Low fat enteral diet; Modular low fat (18%)	Dietary supplement: Low fat enteral diet; The patients are fed as long as the clinically required with the randomly attributed enteral solution; Other Names: modular diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non infectious complications	Any complication will be recorded during the above time frame	up to day 28

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centro Nacional de Quemados, Uruguay
• Investigators: Principal Investigator: Serrana Tihista, RD, Universidad de la República Oriental del Uruguay

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: July 3, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 14, 2014

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Infections, Enteral nutrition, SIRS, critically ill
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: Universidad de la República