Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
12 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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