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Phase 2 Completed N=506 Randomized Quadruple-blind Treatment

The Effect of Nebulized Albuterol on Donor Oxygenation

Brain Death · Organ Donor · Pulmonary Edema
Source: ClinicalTrials.gov NCT00310401 ↗
Enrolled (actual)
506
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcomePrimary: Donor Oxygenation — 49; 40 cmH2O — p=0.98

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.

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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