| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN56543987 |
| Date ISRCTN assigned | 18/05/2007 |
| Local reference number(s) | RGHT000392 |
| 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 |
| Disease/condition/study domain | Acute Lung Injury (ALI) |
| Study hypothesis | Treatment with simvastatin can prevent lung injury in humans undergoing oesophagectomy as assessed by important surrogate clinical outcomes. |
| Design/methodology | Prospective, randomised, double-blind, placebo-controlled clinical trial and an in vitro study. |
| Research ethics review | Approval pending as of 9 March 2007. |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material |
|
| Anticipated start date | 01/08/2007 |
| Anticipated end date | 01/08/2010 |
| Status of trial | Ongoing |
| 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)
|
| Sponsor name | The Royal Group of Hospitals Trust (UK) |
| Sponsor details | Grosvenor Road
Belfast
United Kingdom
BT126BA |
| Sponsor website | http://www.royalhospitals.org/contacts/index.php |
| Contact name | Dr Danny McAuley |
| Contact details | Intensive Care Unit
Royal Victoria Hospital
Grosvenor road
Belfast
United Kingdom
BT12 6BA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN56543987 |
| Date last extracted from ISRCTN register | 17/04/2008 |
