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

Phase 2TerminatedNCT01477697

University of Cincinnati12 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Multiple Trauma

Interventions

Omega-3DIETARY_SUPPLEMENT

50 mg/kg per day of omega-3 fatty acids

PlaceboDIETARY_SUPPLEMENT

50 mg/kg per day of placebo equivalent

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Inflammatory markers

Plasma levels of pro-inflammatory cytokines IL-6 and IL-8, as well as C-reactive protein

Time frame: Up to 28 days

Secondary Outcomes

Infectious complications

Incidence of infectious disease complications using established diagnostic criteria

Time frame: 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

Time frame: Up to 28 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.