Fibrinolytic treatment of acute respiratory failure due to inflammatory lung injury
- Conditions
- acute respiratory failure due to inflammatory lung injuryRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12610000950066
- Lead Sponsor
- St Vincent's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 12
Patients with acute respiratory failure due to an acute inflammatory insult.
Requiring positive pressure ventilation via an endo-tracheal tube.
Impaired oxygenation - arterial partial pressure of oxygen to inspire fraction of oxygen ratio (P/F) <300 mmHg.
At least one quadrant of pulmonary infiltrate present on CXR.
Enrolled within 24 hrs of developing all of these criteria.
Known hypersensitivity to alteplase (t-PA)
Aspirin in the last week
Any therapeutic anti-coagulant therapy
Significant bleeding disorder within the past six months
Any history of brain or spinal injury including trauma, stroke, transient ischaemic attack, neoplasm, surgery, infection, aneurysm or intracranial bleed.
Uncontrolled hypertension, systolic blood pressure (BP) >185 mmHg or diastolic BP >110 mmHg.
Recent (within ten days) prolonged or traumatic cardiopulmonary resuscitation (> 2 minutes), obstetric delivery, organ biopsy, puncture of non-compressible blood vessel (e.g. subclavian vein), major surgery or significant trauma.
Documented ulcerative gastrointestinal disease during the last three months.
Arterial aneurysms, arterial/venous malformations.
Neoplasm with increased bleeding risk.
Bacterial endocarditis, pericarditis.
Acute pancreatitis.
Severe hepatic disease/ dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) or active hepatitis.
Age <18 or > 75
Pulmonary haemorrhage in previous 12 months
Major surgery planned over the next 2 days
Diabetic haemorrhagic retinopathy or other haemorrhagic ophthalmic conditions.
Unlikely to survive 24 hours
Platelet count below 80,000/mm3
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 1 study<br><br>Alveolar dead space will be assessed using an expired breath carbon dioxide analyser[baseline and at 1 and 4 hours post t-pa];pulmonary artery pressure and cardiac function will be assessed using echocardiology[baseline and at 1 and 4 hours post t-pa];safety (bleeding) will be assessed by monitoring of the patient in the Intensive Care Unit for fall in Haemoglobin levels or clinical evidence of bleeding[in 24 hours following the t-pa]
- Secondary Outcome Measures
Name Time Method urinary albumin creatinine ratio will be assessed by analysing albumin and creatinine levels in the urine[baseline and at 1 and 4 hours post t-pa]