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

Phase 1

Terminated

• Conditions: Multiple Trauma
• Interventions: Dietary Supplement: Omega-3; Dietary Supplement: Placebo

• Registration Number: NCT01477697
• Lead Sponsor: University of Cincinnati

Brief Summary

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

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3	Omega-3	50 mg/kg per day of omega-3 fatty acids (DHA Omega-3, Martek Biosciences, Columbia, MD)
Placebo	Placebo	50 mg/kg per day of vehicle

Primary Outcome Measures

Name	Time	Method
Inflammatory markers	Up to 28 days	Plasma levels of pro-inflammatory cytokines IL-6 and IL-8, as well as C-reactive protein

Secondary Outcome Measures

Name	Time	Method
Infectious complications	Up to 28 days	Incidence of infectious disease complications using established diagnostic criteria
Intensive Care Unit length of stay	Up to 28 days	A count of the number of days during which patients are resident in the Surgical Intensive Care Unit

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Cincinnati, Ohio, United States