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NCT Number: NCT00310401

The Effect of Nebulized Albuterol on Donor Oxygenation

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.

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Key information

Conditions

Brain Death Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Hypoxia Lung Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Organ Donor Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Edema Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Unconsciousness

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

California Transplant Donor Network

Oakland, California, 94612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Brain death
  • Consent for lung donation and donor research
  • Release from coroner or medical examiner

Exclusion criteria

  • Age less than 14 years

Treatment and study plan

albuterol

Drug

5 mg nebulized q4h

Other names: salbutamol

Saline

Drug

1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours

Other names: placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Donor Lungs Used for Transplantation

    Time frame: 72 hours

    Number of lungs procured and used for transplantation

  2. 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)

  3. Pulmonary Vascular Resistance

    Time frame: 72 hours

  4. 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).

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • California Transplant Donor Network
  • University of California, San Francisco

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 3, 2006
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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