The Effect of Nebulized Albuterol on Donor Oxygenation
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|ClinicalTrials.gov Identifier: NCT00310401|
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : September 2, 2013
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Brain Death Organ Donor Pulmonary Edema||Drug: Albuterol Drug: Saline||Phase 2|
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 and/or 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||506 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Nebulized Albuterol on Donor Oxygenation|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||June 2011|
Albuterol sulfate 5 mg dissolved in normal saline administered every 4 hours by nebulization
5 mg nebulized q4h
Other Name: salbutamol
Placebo Comparator: Saline
Saline administered every 4 hours by nebulization
5 mg nebulized q4h
Other Name: salbutamol
1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
Other Name: placebo
- Donor Oxygenation [ Time Frame: Change from enrollment to organ procurement (about ~40h after enrollment) ]The primary outcome was the change in oxygenation as measured by change in the PaO2/FiO2 ratio from study enrollment to organ procurement
- Number of Donor Lungs Used for Transplantation [ Time Frame: 72 hours ]Number of lungs procured and used for transplantation
- Lung Compliance [ Time Frame: baseline and at organ procurement (about ~40h after enrollment) ]Static compliance of the respiratory system using plateau pressure (Pplat) measured at end-inspiration and calculated using the equation static compliance = tidal volume/(Pplat - PEEP)
- Pulmonary Vascular Resistance [ Time Frame: 72 hours ]
- Chest X-ray Findings [ Time Frame: change from enrollment to organ procurement (about ~40h after enrollment) ]Chest radiographs were scored using a radiographic score that scored each quadrant for extent of radiographic infiltrates on a scale of 0 to 4, then summed each quadrant for a total score from 0 (no infiltrates) to 16 (extensive infiltrates in all 4 radiographic quadrants).
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): NCT00310401
|United States, California|
|California Transplant Donor Network|
|Oakland, California, United States, 94612|
|Principal Investigator:||Lorraine B Ware, M.D.||Vanderbilt University Medical Center|
|Principal Investigator:||Michael A Matthay, M.D.||University of California, San Francisco|
|Principal Investigator:||Megan Landeck, RN, BSN, APC||California Transplant Donor Network|