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

NCT01581255 | Terminated

• 1 other identifier: OSCILLATE Biomarkers Study
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

acute respiratory distress syndrome; high frequency oscillation ventilation; ventilator-induced lung injury; biomarkers

Outcome Measures

Primary Outcomes (1)

• Change from baseline in biomarkers of ventilator-induced lung injury

  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.

  24 hrs

Study Arms (2)

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 Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• enrollment in OSCILLATE (NCT01506401)

You may not qualify if:

• inability to provide blood samples

Sponsors & Collaborators

• Canadian Critical Care Trials Group: lead
• Canadian Intensive Care Foundation: collaborator

Study Sites (2)

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Links

• OSCILLATE trial

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.

MeSH Terms

Conditions

Respiratory Distress Syndrome; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2012
• First Posted: April 20, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 12, 2012

Record last verified: 2012-09

Locations

CA (2)