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| Name | Class |
|---|---|
| Canadian Intensive Care Foundation | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients randomized to high frequency oscillation | ||
| 2 | Patients randomized to conventional lung protective ventilation |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Informed consent previously obtained for enrollment in the OSCILLATE study:
Exclusion Criteria:
1. Refusal of consent to participate in this biomarkers substudy
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Subset of patients enrolled in the parent study (OSCILLATE- #NCT00474656) Patients enrolled in the parent study have early severe acute respiratory syndrome and will be recruited from a critical care environment
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| Name | Affiliation | Role |
|---|---|---|
| Claudia C DosSantos, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D055397 | Ventilator-Induced Lung Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D055370 | Lung Injury |
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Known biomarkers: IL6, IL8, IL10, IL-1Beta, ICAM-1, TGFBeta, Chemokine ligand 10, FGFBeta, VEGF, and INFGamma Novel biomarkers: ACE, surfactant protein D, clara cell protetin, von Willerbrand Facotr, Ang1, Ang2, and TF, PCIII, neuropeptide Y, PBEF, APCRc, and PAI-1