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

Multiple Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01477697
• Other study ID #: Athota-2010-01
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: November 18, 2011
• Last updated: February 22, 2013
• Start date: June 2011
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Trauma
• Wounds and Injuries

Intervention

Dietary Supplement:
• Omega-3
50 mg/kg per day of omega-3 fatty acids
• Placebo
50 mg/kg per day of placebo equivalent

Locations

Country	Name	City	State
United States	University Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory markers	Plasma levels of pro-inflammatory cytokines IL-6 and IL-8, as well as C-reactive protein	Up to 28 days	No
Secondary	Infectious complications	Incidence of infectious disease complications using established diagnostic criteria	Up to 28 days	No
Secondary	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	No