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

This study has been completed.
Sponsor:
Collaborator:
Canadian Intensive Care Foundation
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00673517
First received: May 5, 2008
Last updated: November 14, 2008
Last verified: November 2008
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Claudia DosSantos, MD, FRCPC, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT00673517     History of Changes
Other Study ID Numbers: OSCILLATE Biomarkers Substudy
Study First Received: May 5, 2008
Last Updated: November 14, 2008
Health Authority: Canada: Ethics Review Committee

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:
Syndrome
Respiratory Distress Syndrome, Newborn
Lung Injury
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Ventilator-Induced Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 16, 2014