Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RGHT000392
Study information
Scientific title
Acronym
Prevention-HARP
Study hypothesis
Treatment with simvastatin can prevent lung injury in humans undergoing oesophagectomy as assessed by important surrogate clinical outcomes.
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Efficacy of simvastatin to improve pulmonary deadspace at 6 hours following oesophagectomy or prior to extubation if earlier.
Secondary outcome measures
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)
Overall trial start date
01/08/2007
Overall trial end date
01/08/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Adult patients undergoing oesophagectomy.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/08/2007
Recruitment end date
01/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Intensive Care Unit
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
The Royal Group of Hospitals Trust (UK)
Sponsor details
Grosvenor Road
Belfast
BT126BA
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Doctoral fellowship scheme, Central Services Agency (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
REVIVE Charity for the regional intensive care unit, the Royal Group of Hospitals Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23817506
Publication citations
-
Results
Shyamsundar M, McAuley DF, Shields MO, MacSweeney R, Duffy MJ, Johnston JR, McGuigan J, Backman JT, Calfee CS, Matthay MM, Griffiths MJ, McDowell C, Elborn SJ, OʼKane CM, Effect of simvastatin on physiological and biological outcomes in patients undergoing esophagectomy: a randomized placebo-controlled trial., Ann. Surg., 2014, 259, 1, 26-31, doi: 10.1097/SLA.0b013e31829d686b.