Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Nebulized Albuterol on Donor Oxygenation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00310401
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : September 2, 2013
Last Update Posted : March 16, 2018
Sponsor:
Collaborators:
California Transplant Donor Network
University of California, San Francisco
Information provided by (Responsible Party):
Lorraine B. Ware, Vanderbilt University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Brain Death
Organ Donor
Pulmonary Edema
Interventions Drug: Albuterol
Drug: Saline
Enrollment 506
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Albuterol Saline
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 260 246
Completed 260 246
Not Completed 0 0
Arm/Group Title Albuterol Saline Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 260 246 506
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants 246 participants 506 participants
<=18 years
14
   5.4%
15
   6.1%
29
   5.7%
Between 18 and 65 years
224
  86.2%
217
  88.2%
441
  87.2%
>=65 years
22
   8.5%
14
   5.7%
36
   7.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 260 participants 246 participants 506 participants
43  (16) 42  (15) 42  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants 246 participants 506 participants
Female
99
  38.1%
88
  35.8%
187
  37.0%
Male
161
  61.9%
158
  64.2%
319
  63.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 260 participants 246 participants 506 participants
260 246 506
1.Primary Outcome
Title Donor Oxygenation
Hide Description The primary outcome was the change in oxygenation as measured by change in the PaO2/FiO2 ratio from study enrollment to organ procurement
Time Frame Change from enrollment to organ procurement (about ~40h after enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol Saline
Hide Arm/Group Description:
Albuterol 5 mg every 4 hour by nebulization
Saline every 4 hours by nebulization
Overall Number of Participants Analyzed 260 246
Median (Inter-Quartile Range)
Unit of Measure: cmH2O
49
(-26 to 149)
40
(-31 to 124)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Albuterol, Saline
Comments Paired T Test was used to compare the change in PaO2/FiO2 ratio from enrollment to procurement between albuterol and saline treated donors
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method Paired T Test
Comments [Not Specified]
2.Secondary Outcome
Title Number of Donor Lungs Used for Transplantation
Hide Description Number of lungs procured and used for transplantation
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol Saline
Hide Arm/Group Description:
Albuterol: 5 mg nebulized q4h
Saline: 1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
Overall Number of Participants Analyzed 260 246
Measure Type: Count of Participants
Unit of Measure: Participants
74
  28.5%
78
  31.7%
3.Secondary Outcome
Title Lung Compliance
Hide Description 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)
Time Frame baseline and at organ procurement (about ~40h after enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol Saline
Hide Arm/Group Description:
Albuterol: 5 mg nebulized q4h
Saline: 1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
Overall Number of Participants Analyzed 260 246
Mean (Standard Deviation)
Unit of Measure: ml/cmH2O
baseline 48  (14) 50  (15)
at organ procurement (mean ~40h after enrollment) 52  (14) 56  (38)
4.Secondary Outcome
Title Pulmonary Vascular Resistance
Hide Description [Not Specified]
Time Frame 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Insufficient data available to analyze this outcome
Arm/Group Title Albuterol Saline
Hide Arm/Group Description:
Albuterol: 5 mg nebulized q4h
Saline: 1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Chest X-ray Findings
Hide Description 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).
Time Frame change from enrollment to organ procurement (about ~40h after enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol Saline
Hide Arm/Group Description:
Albuterol: 5 mg nebulized q4h
Saline: 1.0 cc diluted with saline in identical fashion to study drug and administered by nebulizer every 4 hours
Overall Number of Participants Analyzed 260 246
Mean (Standard Deviation)
Unit of Measure: units on a scale
Enrollment 4.7  (3.3) 4.6  (3.2)
at organ procurement (about ~40h after enrollment) 5.0  (3.2) 4.4  (2.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol Saline
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Albuterol Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/260 (0.00%)   0/246 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Albuterol Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/260 (0.00%)   0/246 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lorraine B. Ware M.D.
Organization: Vanderbilt University
Phone: 615 322 8614
EMail: lorraine.ware@vanderbilt.edu
Publications:
Layout table for additonal information
Responsible Party: Lorraine B. Ware, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00310401     History of Changes
Other Study ID Numbers: 3U01HL081332-01S1 ( U.S. NIH Grant/Contract )
First Submitted: March 1, 2006
First Posted: April 3, 2006
Results First Submitted: June 24, 2013
Results First Posted: September 2, 2013
Last Update Posted: March 16, 2018