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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00673517
First Posted: May 7, 2008
Last Update Posted: November 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Intensive Care Foundation
Information provided by:
St. Michael's Hospital, Toronto
  Purpose
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.

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 Ventilator Induced Lung Injury (VILI): Nested Translational Biology Sub-Study of the OSCILLATE Pilot Study

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
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

Estimated Enrollment: 20
Study Start Date: November 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients randomized to high frequency oscillation
2
Patients randomized to conventional lung protective ventilation

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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673517


Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Intensive Care Foundation
Investigators
Principal Investigator: Claudia C DosSantos, MD St. Michael's Hospital, Toronto
  More Information

Responsible Party: Claudia DosSantos, MD, FRCPC, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT00673517     History of Changes
Other Study ID Numbers: OSCILLATE Biomarkers Substudy
First Submitted: May 5, 2008
First Posted: May 7, 2008
Last Update Posted: November 17, 2008
Last Verified: November 2008

Keywords provided by St. Michael's Hospital, Toronto:
Acute respiratory distress syndrome
Ventilator induced lung injury
High frequency oscillation
Lung protective ventilation
Biomarkers
Biotrauma

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