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

Primary Purpose

Multiple Trauma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Omega-3
Placebo
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Trauma focused on measuring Trauma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy 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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Omega-3

Placebo

Arm Description

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

50 mg/kg per day of vehicle

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 18, 2011
Last Updated
February 22, 2013
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT01477697
Brief Title
Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients
Official Title
Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to slow enrollment and interim analysis showing no difference between treatment arms.
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Trauma
Keywords
Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3
Arm Type
Active Comparator
Arm Description
50 mg/kg per day of omega-3 fatty acids (DHA Omega-3, Martek Biosciences, Columbia, MD)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
50 mg/kg per day of vehicle
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Intervention Description
50 mg/kg per day of omega-3 fatty acids
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
50 mg/kg per day of placebo equivalent
Primary Outcome Measure Information:
Title
Inflammatory markers
Description
Plasma levels of pro-inflammatory cytokines IL-6 and IL-8, as well as C-reactive protein
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
Infectious complications
Description
Incidence of infectious disease complications using established diagnostic criteria
Time Frame
Up to 28 days
Title
Intensive Care Unit length of stay
Description
A count of the number of days during which patients are resident in the Surgical Intensive Care Unit
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krishna Athota, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard Branson, MSc
Organizational Affiliation
University of Cincinnati
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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