Phase 2
N=506
The Effect of Nebulized Albuterol on Donor Oxygenation
Brain Death · Organ Donor · Pulmonary Edema
Bottom Line
View on ClinicalTrials.gov: NCT00310401 ↗Enrolled (actual)
506
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Donor Oxygenation — 49; 40 cmH2O — p=0.98
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Albuterol (Drug); Saline (Drug)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Donor Oxygenation |
49; 40 | 0.98 |
| SECONDARY Number of Donor Lungs Used for Transplantation |
74; 78 | — |
| SECONDARY Lung Compliance |
48; 50; 52; 56 | — |
| SECONDARY Pulmonary Vascular Resistance |
— | — |
| SECONDARY Chest X-ray Findings |
4.7; 4.6; 5.0; 4.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Brain death
- Consent for lung donation and donor research
- Release from coroner or medical examiner
Exclusion Criteria
- Age less than 14 years
Data sourced from ClinicalTrials.gov (NCT00310401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.