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

Primary Purpose

Burn Injury

Status

Unknown status

Phase

Not Applicable

Locations

Uruguay

Study Type

Interventional

Intervention

ω-3 PUFA

Low fat enteral diet

About this trial

This is an interventional supportive care trial for Burn Injury focused on measuring Infections, Enteral nutrition, SIRS, critically ill

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centro National de QuemadosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ω-3 PUFA

Low fat enteral diet

Arm Description

Modular low fat diet (18%) including 9% as ω-3 PUFA

Modular low fat (18%)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Non infectious complications

Any complication will be recorded during the above time frame

Full Information

NCT ID

NCT02189538

First Posted

July 3, 2014

Last Updated

February 14, 2017

Sponsor

Centro Nacional de Quemados, Uruguay

1. Study Identification

Unique Protocol Identification Number

NCT02189538

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centro Nacional de Quemados, Uruguay

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burn Injury

Keywords

Infections, Enteral nutrition, SIRS, critically ill

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ω-3 PUFA

Arm Type

Experimental

Arm Description

Modular low fat diet (18%) including 9% as ω-3 PUFA

Arm Title

Low fat enteral diet

Arm Type

Active Comparator

Arm Description

Modular low fat (18%)

Intervention Type

Dietary Supplement

Intervention Name(s)

ω-3 PUFA

Other Intervention Name(s)

modular preparation: 9% ω-3 of the total 18% fat

Intervention Description

The patients are fed as long as the clinically required with the randomly attributed enteral solution.

Intervention Type

Dietary Supplement

Intervention Name(s)

Low fat enteral diet

Other Intervention Name(s)

modular diet

Intervention Description

The patients are fed as long as the clinically required with the randomly attributed enteral solution

Primary Outcome Measure Information:

Title

Number of infections

Description

Infectious complications will be recorded according to CDC criteria, and grouped as pulmonary, blood stream infections (catheter related or not), cutaneous, abdominal and others

Time Frame

up to Day 28 after burn injury

Secondary Outcome Measure Information:

Title

Non infectious complications

Description

Any complication will be recorded during the above time frame

Time Frame

up to day 28

Other Pre-specified Outcome Measures:

Title

Duration of mechanical ventilation

Description

Time on mechanical ventilation though an endotracheal tube (naso-tracheal or tracheostomy)

Time Frame

up to day 28

Title

Length of ICU and hospital stay

Description

ICU and hospital to discharge but maximum for 28 days

Time Frame

up to day 28

Title

Mortality

Time Frame

Hospital stay

Title

Magnitude of CRP increase

Description

C-reactive protein as determined for clinical purpose, Temperature (maximal T° per day), Leucocytes

Time Frame

during ICU stay and up to day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Serrana Tihista, RD

Organizational Affiliation

Universidad de la República Oriental del Uruguay

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centro National de Quemados

City

Montevideo

Country

Uruguay

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Serrana Tihista, RD

Phone

(598) 2613 35 63

serranatihista@hotmail.com

First Name & Middle Initial & Last Name & Degree

Serrana Tihista, RD

First Name & Middle Initial & Last Name & Degree

Julio Roberto Cabrera Martin, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

28153504

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.

Results Reference

derived

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

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