NCT02189538

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 15, 2017

Status Verified

February 1, 2016

Enrollment Period

4.9 years

First QC Date

July 3, 2014

Last Update Submit

February 14, 2017

Conditions

Burn Injury

Keywords

Infections, Enteral nutrition, SIRS, critically ill

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Non infectious complications

    up to day 28

Other Outcomes (4)

  • Duration of mechanical ventilation

    up to day 28

  • Length of ICU and hospital stay

    up to day 28

  • Mortality

    Hospital stay

  • +1 more other outcomes

Study Arms (2)

ω-3 PUFA

EXPERIMENTAL

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

Dietary Supplement: ω-3 PUFA

Low fat enteral diet

ACTIVE COMPARATOR

Modular low fat (18%)

Dietary Supplement: Low fat enteral diet

Interventions

ω-3 PUFADIETARY_SUPPLEMENT

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

Also known as: modular preparation: 9% ω-3 of the total 18% fat
ω-3 PUFA
Low fat enteral dietDIETARY_SUPPLEMENT

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

Also known as: modular diet
Low fat enteral diet

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- adult \>16 years, burns \> 15% BSA, mechanical ventilation, next of kin consent

You may not qualify if:

  • absence of the above, absence of commitment to full treatment
  • comorbidities (cancer, COPD, diabetes, liver failure (Child Pugh B and C)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro National de Quemados

Montevideo, Uruguay

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28153504DERIVED

MeSH Terms

Conditions

BurnsInfectionsCritical Illness

Interventions

CD36 Antigens

Condition Hierarchy (Ancestors)

Wounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Platelet Membrane GlycoproteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesFatty Acid Transport ProteinsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsReceptors, Cell SurfaceReceptors, ImmunologicScavenger Receptors, Class BReceptors, ScavengerReceptors, LDLReceptors, Lipoprotein

Study Officials

  • Serrana Tihista, RD

    Universidad de la República Oriental del Uruguay

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dietitian

Study Record Dates

First Submitted

July 3, 2014

First Posted

July 14, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2017

Study Completion

February 1, 2018

Last Updated

February 15, 2017

Record last verified: 2016-02

Locations

UR(1)