Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Effect of High Frequency Oscillation on Biological Markers of Lung Injury

This study has been terminated.
(Parent study (OSCILLATE) stopped by the Data Monitoring Committee)
Sponsor:
Collaborator:
Canadian Intensive Care Foundation
Information provided by (Responsible Party):
Canadian Critical Care Trials Group
ClinicalTrials.gov Identifier:
NCT01581255
First received: April 17, 2012
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

Mechanical ventilation, although life-saving, damages the lungs through what is known as ventilator-induced lung injury. High frequency oscillation ventilation has been proposed as a ventilation method that may be less injurious to the lungs than conventional mechanical ventilation and may lead to better patient outcomes. To evaluate this hypothesis, the OSCILLATE trial is comparing outcomes in patients with the acute respiratory distress syndrome randomized to high frequency oscillation ventilation vs conventional lung protective ventilation. The present study is a substudy of the OSCILLATE trial looking at biomarkers of ventilator-induced lung injury in blood samples drawn from patients enrolled in OSCILLATE. The objective is to look for biochemical evidence of decreased ventilator-induced lung injury in patients treated with high frequency oscillation ventilation relative to conventional ventilation.


Condition
Acute Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of High Frequency Oscillation on Biological Markers of Lung Injury

Resource links provided by NLM:


Further study details as provided by Canadian Critical Care Trials Group:

Primary Outcome Measures:
  • Change from baseline in biomarkers of ventilator-induced lung injury [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    The following biomarkers will be measured in patients enrolled in both arms of the OSCILLATE trial (high frequency oscillation ventilation and conventional lung protective ventilation) at randomization and again at 24 hrs post randomization: IL-1β, IL-6, IL-8, IL-10, IFN-γ, TGF-β, TNF-α, VEGF, sICAM-1, surfactant protein D (SP-D), Krebs von den Lungen protein (KL-6), Clara cell 16 kD protein (CC16), Angiopoietin-1, Angiopoietin-2, and vWF.


Biospecimen Retention:   Samples Without DNA

Blood samples will be drawn to measure the following biomarkers of ventilator-induced lung injury: IL-1β, IL-6, IL-8, IL-10, IFN-γ, TGF-β, TNF-α, VEGF, sICAM-1, surfactant protein D (SP-D), Krebs von den Lungen protein (KL-6), Clara cell 16 kD protein (CC16), Angiopoietin-1, Angiopoietin-2, and vWF.


Enrollment: 2
Study Start Date: February 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Conventional lung protective ventilation
Critically-ill patients with the acute respiratory distress syndrome randomized to the conventional lung protective ventilation arm of the OSCILLATE trial.
High frequency oscillation ventilation
Critically-ill patients with the acute respiratory distress syndrome randomized to the high frequency oscillation ventilation arm of the OSCILLATE trial.

  Eligibility

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Critically-ill patients with the acute respiratory distress syndrome enrolled in the OSCILLATE trial (NCT01506401).

Criteria

Inclusion Criteria:

  • enrollment in OSCILLATE (NCT01506401)

Exclusion Criteria:

  • inability to provide blood samples
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01581255

Locations
Canada, Ontario
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Canadian Critical Care Trials Group
Canadian Intensive Care Foundation
Investigators
Principal Investigator: Alexandra Binnie, MD, DPhil University of Toronto
Principal Investigator: Claudia dos Santos, MD, PhD University of Toronto
Principal Investigator: Niall Ferguson, MD, MSc University of Toronto
  More Information

Additional Information:
No publications provided

Responsible Party: Canadian Critical Care Trials Group
ClinicalTrials.gov Identifier: NCT01581255     History of Changes
Other Study ID Numbers: OSCILLATE Biomarkers Study
Study First Received: April 17, 2012
Last Updated: September 10, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Canadian Critical Care Trials Group:
acute respiratory distress syndrome
high frequency oscillation ventilation
ventilator-induced lung injury
biomarkers

Additional relevant MeSH terms:
Acute Lung Injury
Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014