Condition category
Respiratory
Date applied
14/04/2006
Date assigned
07/07/2006
Last edited
16/09/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fang Gao

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Heart of England NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Research organisation

Funder name

Intensive Care Society

Alternative name(s)

ICS

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes