Prevention by HMGCoA reductase inhibition of Acute Lung Injury (ALI) associated with one lung ventilation following oesophagectomy by a reduction of pulmonary vascular dysfunction and inflammatio
Completed
- Conditions
- Acute Lung Injury (ALI)RespiratoryAcute lung Injury
- Registration Number
- ISRCTN56543987
- Lead Sponsor
- The Royal Group of Hospitals Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Adult patients undergoing oesophagectomy.
Exclusion Criteria
1. Age < 18 years
2. Pregnancy
3. Creatine Kinase (CK) > 5 times upper limit of normal range
4. Transaminases > 3 times upper limit of normal range
5. Severe renal impairment (calculated creatinine clearance less than 30 mL/minute)
6. Severe liver disease (Child?s Pugh score > 11)
7. Participation in other trials within 30 days
8. Current treatment with statins
9. Inability to take oral medication pre-operatively
10. Patients taking corticosteroids or non-steroidal anti-inflammatory drugs
11. Consent declined
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of simvastatin to improve pulmonary deadspace at 6 hours following oesophagectomy or prior to extubation if earlier.
- Secondary Outcome Measures
Name Time Method 1. Oxygenation assessed by the PaO2: FiO2 ratio 6 hours following oesophagectomy<br>2. Respiratory system compliance (Crs) at 6 hours following oesophagectomy or prior to extubation if earlier <br>3. Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSARs)