Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients

Study Overview
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Brief Summary
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This study will evaluate the effects of omega-3 fatty acid supplementation on inflammation in trauma patients. The main hypothesis is that such supplementation will reduce the presence of biomarkers of systemic inflammation, as compared to placebo

Detailed Description
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This prospective, randomized study will evaluate the effects of omega-3 fatty acid supplementation on inflammatory response in multi-injured trauma patients. Its primary objective is to compare the intensity of inflammation between an active omega-3 group and a placebo group.

Official Title
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Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients

Conditions
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Multiple Trauma

Intervention / Treatment
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* Dietary Supplement: Omega-3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multi-system blunt trauma patients Ages 18 through 65 years, inclusive Admission to ICU Nasogastric or nasoenteric feeding tube in place Intention of primary medical team to feed the patient enterally Exclusion Criteria: Expected mortality within 48 hours Intracranial hemorrhage Pregnant or breast feeding Patient, surrogate, or physician not committed to full support Refractory shock Unable to obtain enteral access Presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction Current total parenteral nutrition (TPN) use, or intent to use TPN within 7 days Current gastrointestinal bleeding Requirement for vasopressors

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3<br>50 mg/kg per day of omega-3 fatty acids (DHA Omega-3, Martek Biosciences, Columbia, MD) | Dietary Supplement: Omega-3<br>* 50 mg/kg per day of omega-3 fatty acids<br>|
| Placebo Comparator: Placebo<br>50 mg/kg per day of vehicle | Dietary Supplement: Placebo<br>* 50 mg/kg per day of placebo equivalent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers | Plasma levels of pro-inflammatory cytokines IL-6 and IL-8, as well as C-reactive protein | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious complications | Incidence of infectious disease complications using established diagnostic criteria | Up to 28 days | 
| Intensive Care Unit length of stay | A count of the number of days during which patients are resident in the Surgical Intensive Care Unit | Up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma