BALTI-2: Beta Agonists in Lung Injury Trial - BALTI-2

Phase 1

• Conditions: Acute respiratory distress syndrome (ARDS)

• Registration Number: EUCTR2006-002647-86-GB
• Lead Sponsor: Heart of England NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-27
• Study Completion: 2011-04-26
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1334

Inclusion Criteria

Intubated patients (16 years of age or older) requiring mechanical ventilation within 72 hours of the onset of acute respiratory distress syndrome defined according to the American European Consensus definition of:
- acute onset
- severe hypoxaemic respiratory failure (PaO2/FiO2 < 26.7 kPa)
- bilateral infiltrates on chest radiograph in the absence of clinical evidence of left atrial hypertension
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnancy
- current treatment with intravenous beta2-agonists
- current treatment with beta-adrenergic antagonists
- treatment withdrawal imminent
- chronic liver disease (defined as Pugh's grading 3: coma, bilirubin >55 mmol/l, albumin <20g/l and prothrombin time >6 seconds compared with control)
- enrolled in another clinical trial of an investigational medicinal product in the past 28 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified