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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
ISRCTN ISRCTN56543987
DOI 10.1186/ISRCTN56543987
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym Prevention-HARP
Serial number at source RGHT000392
Study hypothesis Treatment with simvastatin can prevent lung injury in humans undergoing oesophagectomy as assessed by important surrogate clinical outcomes.
Lay summary Not provided at time of registration
Ethics approval Office for Research Ethics Committees Northern Ireland (ORECNI). Date of approval: 20/07/2007 (ref: 07/NIR02/83)
Study design Prospective, randomised, double-blind, placebo-controlled clinical trial and an in vitro study.
Countries of recruitment United Kingdom
Disease/condition/study domain Acute Lung Injury (ALI)
Participants - inclusion criteria Adult patients undergoing oesophagectomy.
Participants - 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
Anticipated start date 01/08/2007
Anticipated end date 01/08/2010
Status of trial Completed
Patient information material
Target number of participants 40
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.
Primary outcome measure(s) Efficacy of simvastatin to improve pulmonary deadspace at 6 hours following oesophagectomy or prior to extubation if earlier.
Secondary outcome measure(s) 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)
Sources of funding 1. Doctoral fellowship scheme, Central Services Agency (UK)
2. REVIVE – Charity for the regional intensive care unit, the Royal Group of Hospitals Trust (UK)
Trial website
Publications 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23817506
Contact name Dr  Danny  McAuley
  Address Intensive Care Unit
Royal Victoria Hospital
Grosvenor road
  City/town Belfast
  Zip/Postcode BT12 6BA
  Country United Kingdom
Sponsor The Royal Group of Hospitals Trust (UK)
  Address Grosvenor Road
  City/town Belfast
  Zip/Postcode BT126BA
  Country United Kingdom
  Sponsor website: http://www.royalhospitals.org/contacts/index.php
Date applied 09/03/2007
Last edited 04/04/2014
Date ISRCTN assigned 18/05/2007
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