Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310401
Status:
COMPLETED
Last Update Posted:
2018-03-16
First Post:
2006-03-01
Brief Title:
The Effect of Nebulized Albuterol on Donor Oxygenation
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
The Effect of Nebulized Albuterol on Donor Oxygenation
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the effectiveness of albuterol versus placebo with the following specific aims a Treatment of brain dead organ donors with albuterol will reduce pulmonary edema improve donor oxygenation and increase the number of lungs available for transplantation b Developing a blood test to predict the development of primary graft dysfunction in lung transplant recipients and c treating brain dead organ donors with albuterol will decrease markers of primary graft dysfunction and lead to improved lung transplant recipient outcomes and to higher rates of lungs suitable for transplantation
Detailed Description:
The donor lung utilization rate in the United States remains less than 15 and the demand for donor lungs far exceeds the available supply The most common reasons for failure to utilize donor lungs are donor hypoxemia andor pulmonary infiltrates Since pulmonary edema is a common reversible cause of hypoxemia and infiltrates in patients with brain injury strategies to treat pulmonary edema in organ donors should lead to improved donor oxygenation and higher rates of donor lung utilization Inhaled beta-2 agonists increase the rate of alveolar fluid clearance and reduce pulmonary edema in both animal and human lungs In addition our group has recently reported that the majority of human donor lungs that are rejected for transplantation have measurable pulmonary edema and respond to beta-2 agonists with increased rates of alveolar fluid clearance Based on this compelling scientific evidence we propose to test the efficacy of an inhaled beta-2 agonist to increase the rate of alveolar fluid clearance and reduce pulmonary edema in brain dead organ donors with the following specific aims
Specific Aim 1 To test the effect of aerosolized albuterol on donor oxygenation in a multicenter randomized double-blinded placebo-controlled trial in 500 brain dead organ donors managed over a 2 year period by the California Transplant Donor Network CTDN
Hypothesis 1a Treatment of brain dead organ donors with aerosolized albuterol will improve donor oxygenation and increase the donor lung utilization rate compared to treatment with placebo
Hypothesis 1b Treatment of brain dead organ donors with aerosolized albuterol will reduce the severity of pulmonary edema in procured lungs compared to treatment with placebo
Specific Aim 2 To develop and validate a panel of biological markers that can predict and diagnose acute lung injury due to primary graft dysfunction in lung transplant recipients
Hypothesis 2a A panel of plasma biological markers measured in brain dead organ donors that includes markers of inflammation coagulation endothelial injury and lung epithelial injury will predict the development of primary graft dysfunction in the lung recipient
Hypothesis 2b Treatment of brain dead organ donors with inhaled beta-2 agonists will lead to reductions in levels of a panel of biological markers of inflammation coagulation endothelial injury and lung epithelial injury that will be associated with increased donor lung utilization and improved recipient outcomes
Specific Aim 1 To test the effect of aerosolized albuterol on donor oxygenation in a multicenter randomized double-blinded placebo-controlled trial in 500 brain dead organ donors managed over a 2 year period by the California Transplant Donor Network CTDN
Hypothesis 1a Treatment of brain dead organ donors with aerosolized albuterol will improve donor oxygenation and increase the donor lung utilization rate compared to treatment with placebo
Hypothesis 1b Treatment of brain dead organ donors with aerosolized albuterol will reduce the severity of pulmonary edema in procured lungs compared to treatment with placebo
Specific Aim 2 To develop and validate a panel of biological markers that can predict and diagnose acute lung injury due to primary graft dysfunction in lung transplant recipients
Hypothesis 2a A panel of plasma biological markers measured in brain dead organ donors that includes markers of inflammation coagulation endothelial injury and lung epithelial injury will predict the development of primary graft dysfunction in the lung recipient
Hypothesis 2b Treatment of brain dead organ donors with inhaled beta-2 agonists will lead to reductions in levels of a panel of biological markers of inflammation coagulation endothelial injury and lung epithelial injury that will be associated with increased donor lung utilization and improved recipient outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None