Trial Outcomes & Findings for The Effect of Nebulized Albuterol on Donor Oxygenation (NCT NCT00310401)

Results Overview

The primary outcome was the change in oxygenation as measured by change in the PaO2/FiO2 ratio from study enrollment to organ procurement

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

506 participants

Primary outcome timeframe

Change from enrollment to organ procurement (about ~40h after enrollment)

Results posted on

2018-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Albuterol	Saline
Overall Study STARTED	260	246
Overall Study COMPLETED	260	246
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Nebulized Albuterol on Donor Oxygenation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Albuterol n=260 Participants	Saline n=246 Participants	Total n=506 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	224 Participants n=5 Participants	217 Participants n=7 Participants	441 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	14 Participants n=7 Participants	36 Participants n=5 Participants
Age, Continuous	43 years STANDARD_DEVIATION 16 • n=5 Participants	42 years STANDARD_DEVIATION 15 • n=7 Participants	42 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	99 Participants n=5 Participants	88 Participants n=7 Participants	187 Participants n=5 Participants
Sex: Female, Male Male	161 Participants n=5 Participants	158 Participants n=7 Participants	319 Participants n=5 Participants
Region of Enrollment United States	260 participants n=5 Participants	246 participants n=7 Participants	506 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Albuterol n=260 Participants Albuterol 5 mg every 4 hour by nebulization	Saline n=246 Participants Saline every 4 hours by nebulization
Donor Oxygenation	49 cmH2O Interval -26.0 to 149.0	40 cmH2O Interval -31.0 to 124.0

SECONDARY outcome

Timeframe: 72 hours

Number of lungs procured and used for transplantation

Outcome measures

Outcome measures
Measure	Albuterol n=260 Participants Albuterol 5 mg every 4 hour by nebulization	Saline n=246 Participants Saline every 4 hours by nebulization
Number of Donor Lungs Used for Transplantation	74 Participants	78 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Albuterol n=260 Participants Albuterol 5 mg every 4 hour by nebulization	Saline n=246 Participants Saline every 4 hours by nebulization
Lung Compliance baseline	48 ml/cmH2O Standard Deviation 14	50 ml/cmH2O Standard Deviation 15
Lung Compliance at organ procurement (mean ~40h after enrollment)	52 ml/cmH2O Standard Deviation 14	56 ml/cmH2O Standard Deviation 38

SECONDARY outcome

Timeframe: 72 hours

Population: Insufficient data available to analyze this outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Albuterol n=260 Participants Albuterol 5 mg every 4 hour by nebulization	Saline n=246 Participants Saline every 4 hours by nebulization
Chest X-ray Findings Enrollment	4.7 units on a scale Standard Deviation 3.3	4.6 units on a scale Standard Deviation 3.2
Chest X-ray Findings at organ procurement (about ~40h after enrollment)	5.0 units on a scale Standard Deviation 3.2	4.4 units on a scale Standard Deviation 2.8

Adverse Events

Albuterol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lorraine B. Ware M.D.

Vanderbilt University

Phone: 615 322 8614

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place