Burn InjuryOmegaBurnNCT02189538
Effect of n-3 PUFA From Fish in Enteral Nutrition of Major Burn Patients
A study testing ω-3 PUFA and Low fat enteral diet in people with Burn Injury, run by Centro Nacional de Quemados, Uruguay at 1 site in Uruguay.
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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Burn Injury
- What is being tested?
- ω-3 PUFA and Low fat enteral diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUruguay
- Study dates
- Jan 2013to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult >16 years, burns > 15% BSA, mechanical ventilation, next of kin consent
Who cannot join
- absence of the above, absence of commitment to full treatment
- comorbidities (cancer, COPD, diabetes, liver failure (Child Pugh B and C)
- pregnancy
Trial locations and contacts
1 site in 1 country.
Uruguay1 site, 1 recruiting
- Recruiting
Centro National de Quemados
Montevideo
Serrana Tihista, RD, (598) 2613 35 63, serranatihista@hotmail.com
Serrana Tihista, RD
About this study
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
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.
Read the 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.
- Conditions
- Burn Injury
- Being tested
- ω-3 PUFA, Low fat enteral diet
- Keywords
- Infections, Enteral nutrition, SIRS, critically ill
- Medical subject headings
- Burns, Infections, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ω-3 PUFADietary supplement
Also called modular preparation: 9% ω-3 of the total 18% fat
The patients are fed as long as the clinically required with the randomly attributed enteral solution.
Low fat enteral dietDietary supplement
Also called modular diet
The patients are fed as long as the clinically required with the randomly attributed enteral solution
| Study group | Role | What they receive |
|---|---|---|
| ω-3 PUFA | Experimental | Modular low fat diet (18%) including 9% as ω-3 PUFA Receives: Dietary Supplement: ω-3 PUFA |
| Low fat enteral diet | Active comparator | Modular low fat (18%) Receives: Dietary Supplement: Low fat enteral diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to Day 28 after burn injury
Secondary outcomes (1)
Non infectious complications
Any complication will be recorded during the above time frame
Measured: up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Nacional de Quemados, Uruguay
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serrana Tihista, Centro Nacional de Quemados, Uruguay
- Investigators
- Serrana Tihista, RD, Principal investigator, Universidad de la República Oriental del Uruguay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189538
- Sponsor's protocol ID
- Universidad de la República
- Acronym
- OmegaBurn
- Status last verified
- Feb 2016
- First submitted
- 3 Jul 2014
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28153504
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02189538
- Acronym / sponsor ID
- OmegaBurn / Universidad de la República
- Conditions
- Burn Injury
- Keywords
- Infections, Enteral nutrition, SIRS, critically ill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Nacional de Quemados, UruguayUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ω-3 PUFA | Experimental | Dietary Supplement: ω-3 PUFAModular low fat diet (18%) including 9% as ω-3 PUFA |
| Low fat enteral diet | Active comparator | Dietary Supplement: Low fat enteral dietModular low fat (18%) |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adult >16 years, burns > 15% BSA, mechanical ventilation, next of kin consent
Key exclusion criteria (3 listed)
- absence of the above, absence of commitment to full treatment
- comorbidities (cancer, COPD, diabetes, liver failure (Child Pugh B and C)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ω-3 PUFAAlso: modular preparation: 9% ω-3 of the total 18% fatThe patients are fed as long as the clinically required with the randomly attributed enteral solution. | Dietary supplement | ω-3 PUFA |
| Low fat enteral dietAlso: modular dietThe patients are fed as long as the clinically required with the randomly attributed enteral solution | Dietary supplement | Low fat enteral diet |
Primary outcome
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
1 secondary outcome
Non infectious complications
Time frame: up to day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Derived from this study: PubMed 28153504Tihista 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serrana Tihista, RD principal investigator
Universidad de la República Oriental del Uruguay
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ω-3 PUFA and Low fat enteral diet in people with Burn Injury, run by Centro Nacional de Quemados, Uruguay at 1 site in Uruguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of infections (time frame: up to Day 28 after burn injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02189538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.