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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

The Effect of High Frequency Oscillation on Biological Markers of Ventilator Induced Lung Injury (VILI): Nested Translational Biology Sub-Study of the OSCILLATE Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673517
• Other study ID #: OSCILLATE Biomarkers Substudy
• Status: Completed
• Phase: N/A
• First received: May 5, 2008
• Last updated: November 14, 2008
• Start date: November 2007
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

Although mechanical ventilation is life saving, it is associated with a number of severe complications collectively referred to as ventilator induced lung injury (VILI). VILI contributes to the high morbidity and mortality associated with the acute respiratory distress syndrome (ARDS). Within the context of a randomized study evaluating the feasibility of conducting a study comparing high frequency oscillation to conventional lung protective ventilation in early severe ARDS, we are evaluating the effect of both ventilator strategies on biological markers of VILI.

Description:

Specific objectives:

To measure known biomarkers conventionally associated with VILI and biotrauma To measure potential novel biomarkers of VILI and biotrauma To identify the best time point for biomarker measurement To collect and store samples for differential expression and genomic analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Informed consent previously obtained for enrollment in the OSCILLATE study:

1. Acute onset of respiratory failure

2. Endotracheal intubation or tracheostomy

3. Hypoxemia (P:F <200 mmHg)

4. Bilateral alveolar consolidation

Exclusion Criteria:

1. Refusal of consent to participate in this biomarkers substudy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Ventilator-Induced Lung Injury

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Canadian Intensive Care Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentration of known biomarkers associated with VILI and biotrauma		Baseline, after standardization, 6-10 hours after randomization, 12-16 hours after randomization, 24-30 hours after randomization, 72-76 hours after randomization, and every 3 subsequent days until death, discharge, or completion of the study at 28 days	No
Secondary	Serum concentration of tissue and cell specific markers that are potential novel biomarkers associated with VILI and biotrauma		Baseline, after standardization, 6-10 hours after randomization, 12-16 hours after randomization, 24-30 hours after randomization, 72-76 hours after randomization, and every 3 subsequent days until death, discharge, or completion of the study at 28 days	No