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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of Cincinnati

Current Primary Outcome: Inflammatory markers [ Time Frame: Up to 28 days ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Cincinnati

Dates:
Date Received: November 18, 2011
Date Started: June 2011
Date Completion:
Last Updated: February 22, 2013
Last Verified: February 2013