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 | https://doi.org/10.1186/ISRCTN56543987 |
| Protocol serial number | RGHT000392 |
| Sponsor | The Royal Group of Hospitals Trust (UK) |
| Funders | Doctoral fellowship scheme, Central Services Agency (UK), REVIVE Charity for the regional intensive care unit, the Royal Group of Hospitals Trust (UK) |
- Submission date
- 09/03/2007
- Registration date
- 18/05/2007
- Last edited
- 04/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Danny McAuley
Scientific
Scientific
Intensive Care Unit
Royal Victoria Hospital
Grosvenor road
Belfast
BT12 6BA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomised, double-blind, placebo-controlled clinical trial and an in vitro study. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Prevention-HARP |
| Study objectives | Treatment with simvastatin can prevent lung injury in humans undergoing oesophagectomy as assessed by important surrogate clinical outcomes. |
| Ethics approval(s) | Office for Research Ethics Committees Northern Ireland (ORECNI). Date of approval: 20/07/2007 (ref: 07/NIR02/83) |
| Health condition(s) or problem(s) studied | Acute Lung Injury (ALI) |
| Intervention | Patients will be randomised to simvastatin 80 mg or placebo enterally for 4 days prior to surgery and up to 7 days following surgery. |
| Intervention type | Other |
| Primary outcome measure(s) |
Efficacy of simvastatin to improve pulmonary deadspace at 6 hours following oesophagectomy or prior to extubation if earlier. |
| Key secondary outcome measure(s) |
1. Oxygenation assessed by the PaO2: FiO2 ratio 6 hours following oesophagectomy |
| Completion date | 01/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | Adult patients undergoing oesophagectomy. |
| Key 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 (Childs 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 |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 01/08/2010 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
Intensive Care Unit
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2014 | Yes | No |
