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The Effect of Nebulized Albuterol on Donor Oxygenation

NCT00310401 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 506

Last updated 2018-03-16

Study results available
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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.

Conditions

  • Brain Death
  • Organ Donor
  • Pulmonary Edema

Interventions

DRUG

Albuterol

5 mg nebulized q4h

DRUG

Saline

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

Sponsors & Collaborators

Principal Investigators

  • Lorraine B Ware, M.D. · Vanderbilt University Medical Center

  • Michael A Matthay, M.D. · University of California, San Francisco

  • Megan Landeck, RN, BSN, APC · California Transplant Donor Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-05-31
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00310401 on ClinicalTrials.gov