Trial Outcomes & Findings for The Various Effects of Gaseous Albuterol on Serum Lactate (NCT NCT02073747)

Results Overview

We powered our study to detect a difference of 0.5 mmol/L between pre and post-treatment lactate levels, but hypothesize that the difference will be greater than 1.0 mmol/L.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Change in serum lactate from baseline to 1 hour

Results posted on

2017-08-14

Participant Flow

Healthy volunteers were recruited from the investigators' friends and family.

Participant milestones

Participant milestones
Measure	Normal Saline Control Group Control group will be administered a one hour normal saline inhaled treatment. Normal Saline: One hour inhaled normal saline	Albuterol Trial Group Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol Albuterol: One hour inhaled ten milligrams of albuterol
Overall Study STARTED	15	15
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Various Effects of Gaseous Albuterol on Serum Lactate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Albuterol n=14 Participants Study group	Normal Saline n=14 Participants Control group	Total n=28 Participants Total of all reporting groups
Age, Continuous	29 years n=5 Participants	28 years n=7 Participants	28.5 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change in serum lactate from baseline to 1 hour

We powered our study to detect a difference of 0.5 mmol/L between pre and post-treatment lactate levels, but hypothesize that the difference will be greater than 1.0 mmol/L.

Outcome measures

Outcome measures
Measure	Normal Saline Control Group n=14 Participants Control group will be administered a one hour normal saline inhaled treatment. Normal Saline: One hour inhaled normal saline	Albuterol Trial Group n=14 Participants Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol Albuterol: One hour inhaled ten milligrams of albuterol
Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.	-0.15 mmol/L Interval -0.39 to 0.09	0.77 mmol/L Interval 0.52 to 1.02

Adverse Events

Albuterol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal 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

Emergency Department Research Coordinator

University Medical Center of Southern Nevada

Phone: 702-224-7124

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place