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
- Conditions
- Acute respiratory distress syndromeRespiratoryRespiratory distress syndrome
- Registration Number
- ISRCTN38366450
- Lead Sponsor
- Heart of England NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality 28 days after randomisation
- Secondary Outcome Measures
Name Time Method 1. Number of ventilator-free days<br>2. Mortality at (first) discharge from ICU<br>3. Mortality at discharge from hospital<br>4. Mortality at 12 months post randomisation<br>5. ICU length of stay<br>6. Hospital length of stay<br>7. Disability and quality of life at 12 months after randomisation