The Effect of High Frequency Oscillation on Biological Markers of Lung Injury
| Tracking Information | |||||
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| First Received Date ICMJE | May 5, 2008 | ||||
| Last Updated Date | November 14, 2008 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Serum concentration of known biomarkers associated with VILI and biotrauma [ Time Frame: 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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00673517 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Serum concentration of tissue and cell specific markers that are potential novel biomarkers associated with VILI and biotrauma [ Time Frame: 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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of High Frequency Oscillation on Biological Markers of Lung Injury | ||||
| Official Title ICMJE | 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 | ||||
| Brief 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. |
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| Detailed 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: 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 |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | 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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| Condition ICMJE | Acute Respiratory Distress Syndrome | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Completion Date | November 2008 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00673517 | ||||
| Other Study ID Numbers ICMJE | OSCILLATE Biomarkers Substudy | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Claudia DosSantos, MD, FRCPC, St. Michael's Hospital | ||||
| Study Sponsor ICMJE | St. Michael's Hospital, Toronto | ||||
| Collaborators ICMJE | Canadian Intensive Care Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | St. Michael's Hospital, Toronto | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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