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

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ClinicalTrials.gov Identifier: NCT02189538
Recruitment Status : Unknown
Verified February 2016 by Serrana Tihista, Centro Nacional de Quemados, Uruguay.
Recruitment status was:  Recruiting
First Posted : July 14, 2014
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
Serrana Tihista, Centro Nacional de Quemados, Uruguay

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.


Condition or disease Intervention/treatment Phase
Burn Injury Dietary Supplement: ω-3 PUFA Dietary Supplement: Low fat enteral diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
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 Start Date : January 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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 Name: 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 Name: modular diet




Primary Outcome Measures :
  1. Number of infections [ Time Frame: up to Day 28 after burn injury ]
    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 :
  1. Non infectious complications [ Time Frame: up to day 28 ]
    Any complication will be recorded during the above time frame


Other Outcome Measures:
  1. Duration of mechanical ventilation [ Time Frame: up to day 28 ]
    Time on mechanical ventilation though an endotracheal tube (naso-tracheal or tracheostomy)

  2. Length of ICU and hospital stay [ Time Frame: up to day 28 ]
    ICU and hospital to discharge but maximum for 28 days

  3. Mortality [ Time Frame: Hospital stay ]
  4. Magnitude of CRP increase [ Time Frame: during ICU stay and up to day 28 ]
    C-reactive protein as determined for clinical purpose, Temperature (maximal T° per day), Leucocytes



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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189538


Locations
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Uruguay
Centro National de Quemados Recruiting
Montevideo, Uruguay
Contact: Serrana Tihista, RD    (598) 2613 35 63    serranatihista@hotmail.com   
Principal Investigator: Serrana Tihista, RD         
Sub-Investigator: Julio Roberto Cabrera Martin, MD         
Sponsors and Collaborators
Centro Nacional de Quemados, Uruguay
Investigators
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Principal Investigator: Serrana Tihista, RD Universidad de la República Oriental del Uruguay
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Serrana Tihista, dietitian, Centro Nacional de Quemados, Uruguay
ClinicalTrials.gov Identifier: NCT02189538    
Other Study ID Numbers: Universidad de la República
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: February 15, 2017
Last Verified: February 2016
Keywords provided by Serrana Tihista, Centro Nacional de Quemados, Uruguay:
Infections, Enteral nutrition, SIRS, critically ill
Additional relevant MeSH terms:
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Burns
Wounds and Injuries