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 inflammation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN56543987

Enrollment

Registered

2007-05-18

Start date

2007-08-01

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 Lung Injury (ALI) Respiratory Acute lung Injury

Interventions

Patients will be randomised to simvastatin 80 mg or placebo enterally for 4 days prior to surgery and up to 7 days following surgery.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients undergoing oesophagectomy.

Exclusion criteria

Exclusion criteria: 1. Age 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

Design outcomes

Primary

Measure	Time frame
Efficacy of simvastatin to improve pulmonary deadspace at 6 hours following oesophagectomy or prior to extubation if earlier.	—

Secondary

Measure	Time frame
1. Oxygenation assessed by the PaO2: FiO2 ratio 6 hours following oesophagectomy 2. Respiratory system compliance (Crs) at 6 hours following oesophagectomy or prior to extubation if earlier 3. Occurrence of Suspected Unexpected Serious Adverse Reactions (SUSARs)	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026