NCT00351533

Brief Summary

The purpose of this study is to determine whether fish oil (containing omega-3 fatty acids) given enterally is safe and effective in reducing lung and systemic inflammation seen in acute lung injury.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2006

Typical duration for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

October 3, 2011

Completed
Last Updated

October 3, 2011

Status Verified

August 1, 2011

Enrollment Period

2.5 years

First QC Date

July 11, 2006

Results QC Date

February 16, 2011

Last Update Submit

August 26, 2011

Conditions

Respiratory Distress Syndrome, AdultAcute Lung InjuryAcute Respiratory Distress Syndrome

Keywords

Respiratory distress syndrome, adultAcute lung injuryAcute respiratory distress syndromeARDS, humanFish oilsFatty Acids, Omega-3Docosahexaenoic AcidsEicosapentaenoic Acid

Outcome Measures

Primary Outcomes (1)

  • Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8

    30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.

    Days 1 and 5

Secondary Outcomes (27)

  • Change in BALF Leukotriene B4

    Days 1 and 5

  • Change in BALF Interleukin-6

    Days 1 and 5

  • Change in BALF Monocyte Chemotactic Protein-1

    Days 1 and 5

  • Change in BALF Neutrophil Count

    Days 1 and 5

  • Static Lung Compliance

    Day 5

  • +22 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Enteral fish oil

Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)

2

PLACEBO COMPARATOR

Enteral saline

Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)

Interventions

Fish oil (eicosapentaenoic acid and docosahexanoic acid)DRUG

Liquid fish oil 7.5cc enterally every 6 hours

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Requiring positive-pressure mechanical ventilation
  • ALI criteria: PaO2/FiO2 \<300, bilateral infiltrates on chest radiograph, no left atrial hypertension
  • Age \> 17 years

You may not qualify if:

  • Expected ICU length of stay \<48 hours
  • Unable to undergo bronchoalveolar lavage at enrollment
  • Unable to obtain enteral access
  • Post-cardiac arrest with suspected significant anoxic brain injury
  • Expected survival \< 28 days
  • Pregnant
  • Platelet count \< 30,000, active bleeding, or international normalized ratio (INR)\>3.0
  • History of ventricular tachycardia or fibrillation
  • Receiving recombinant human activated protein C (rh-APC) for sepsis
  • Acquired immune deficiency syndrome (AIDS) with CD4 count \< 200
  • Metastatic cancer
  • History of bone marrow, lung, liver, cardiac, kidney, or pancreas transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

St. Alphonsus Medical Center

Boise, Idaho, 83706, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

University of Vermont/Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Lung Injury

Interventions

Fish OilsEicosapentaenoic Acid

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Injury

Intervention Hierarchy (Ancestors)

OilsLipidsFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsEicosanoidsFatty Acids, UnsaturatedFatty Acids

Results Point of Contact

Title
Renee Stapleton, MD PhD
Organization
University of Vermont
renee.stapleton@uvm.edu
802-656-7975

Study Officials

  • Renee D. Stapleton, MD, MSc

    University of Vermont

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 11, 2006

First Posted

July 13, 2006

Study Start

July 1, 2006

Primary Completion

January 1, 2009

Study Completion

August 1, 2009

Last Updated

October 3, 2011

Results First Posted

October 3, 2011

Record last verified: 2011-08

Locations

CA(1)US(4)