A multicentre, randomised, double-blind, placebo-controlled trial to evaluate intravenous infusion of salbutamol versus saline for 28-day mortality in patients with acute respiratory distress syndrome

ISRCTN	ISRCTN38366450
DOI	https://doi.org/10.1186/ISRCTN38366450
Secondary identifying numbers	Version 2

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Fang Gao
Scientific

Adult Intensive Care Unit
Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Study design	Randomised, double-blind, placebo-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	BALTI-2
Study objectives	In patients with acute respiratory distress syndrome (ARDS), treatment with intravenous salbutamol will reduce 28-day mortality
Ethics approval(s)	West Midlands Multicentre Research Ethics Committee, approval pending as of 01/05/2006
Health condition(s) or problem(s) studied	Acute respiratory distress syndrome
Intervention	Salbutamol or placebo will be administered through a dedicated intravenous line for seven days
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Salbutamol
Primary outcome measure	Mortality 28 days after randomisation
Secondary outcome measures	1. Number of ventilator-free days 2. Mortality at (first) discharge from ICU 3. Mortality at discharge from hospital 4. Mortality at 12 months post randomisation 5. ICU length of stay 6. Hospital length of stay 7. Disability and quality of life at 12 months after randomisation
Overall study start date	01/08/2006
Completion date	01/09/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100
Key inclusion criteria	On day 1 following intensive care unit (ICU) admission, the primary caring ICU clinician should consider all adult patients (age ≥18 years) with severe hypoxaemic respiratory failure (PaO2/FiO2) ≤26.7 kPa to be eligible for inclusion in the trial
Key exclusion criteria	1. Pregnancy 2. Cardiogenic pulmonary oedema (confirmed by medical history and chest x-ray) 3. Severe obstructive airway disease requiring nebulised or intravenous (IV) beta 2-agonists 4. Treatment with beta 2-blockers ≤48 hours 5. Brain stem death 6. Treatment withdrawal ≤24 hours, which indicates any interventions (including a trial) would be considered inappropriate 7. Refusing consent or patients in whom relatives refuse assent 8. Enrolled in another interventional clinical trial in the last 28 days
Date of first enrolment	01/08/2006
Date of final enrolment	01/09/2007

Adult Intensive Care Unit

Birmingham
B9 5SS
United Kingdom

Heart of England NHS Foundation Trust (UK)
Hospital/treatment centre

Birmingham Heartlands Hospital
Bordesley Green East
Birmingham
B9 5SS
England
United Kingdom

Research organisation

Intensive Care Society
Private sector organisation / Associations and societies (private and public)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	09/05/2011	Yes	No
Results article	results	21/01/2012	Yes	No
Results article	results	01/09/2013	Yes	No