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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38366450
Enrollment
100
Registered
2006-07-07
Start date
2006-08-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory distress syndrome Respiratory Respiratory distress syndrome

Interventions

Salbutamol or placebo will be administered through a dedicated intravenous line for seven days

Sponsors

Heart of England NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Mortality 28 days after randomisation

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026