Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 2
Study information
Scientific title
Acronym
BALTI-2
Study hypothesis
In patients with acute respiratory distress syndrome (ARDS), treatment with intravenous salbutamol will reduce 28-day mortality
Ethics approval
West Midlands Multicentre Research Ethics Committee, approval pending as of 01/05/2006
Study design
Randomised, double-blind, placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute respiratory distress syndrome
Intervention
Salbutamol or placebo will be administered through a dedicated intravenous line for seven days
Intervention type
Drug
Phase
Not Specified
Drug names
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 trial start date
01/08/2006
Overall trial end date
01/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant 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
Recruitment start date
01/08/2006
Recruitment end date
01/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Adult Intensive Care Unit
Birmingham
B9 5SS
United Kingdom
Funders
Funder type
Research organisation
Funder name
Intensive Care Society
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21554679
2. 2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22166903
3. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24028755
Publication citations
-
Protocol
Perkins GD, Gates S, Lamb SE, McCabe C, Young D, Gao F, Beta Agonist Lung Injury TrIal-2 (BALTI-2) trial protocol: a randomised, double-blind, placebo-controlled of intravenous infusion of salbutamol in the acute respiratory distress syndrome., Trials, 2011, 12, 113, doi: 10.1186/1745-6215-12-113.
-
Results
Gao Smith F, Perkins GD, Gates S, Young D, McAuley DF, Tunnicliffe W, Khan Z, Lamb SE, , Effect of intravenous β-2 agonist treatment on clinical outcomes in acute respiratory distress syndrome (BALTI-2): a multicentre, randomised controlled trial., Lancet, 2012, 379, 9812, 229-235, doi: 10.1016/S0140-6736(11)61623-1.
-
Results
Gates S, Perkins GD, Lamb SE, Kelly C, Thickett DR, Young JD, McAuley DF, Snaith C, McCabe C, Hulme CT, Gao Smith F, Beta-Agonist Lung injury TrIal-2 (BALTI-2): a multicentre, randomised, double-blind, placebo-controlled trial and economic evaluation of intravenous infusion of salbutamol versus placebo in patients with acute respiratory distress syndrome., Health Technol Assess, 2013, 17, 38, v-vi, 1-87, doi: 10.3310/hta17380.