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
Secondary identifying numbers	RGHT000392

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Danny McAuley
Scientific

Intensive Care Unit
Royal Victoria Hospital
Grosvenor road
Belfast
BT12 6BA
United Kingdom

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
Study setting(s)	Not specified
Study type	Not Specified
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	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 study start date	01/08/2007
Completion date	01/08/2010

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Intensive Care Unit

Belfast
BT12 6BA
United Kingdom

The Royal Group of Hospitals Trust (UK)
Hospital/treatment centre

Grosvenor Road
Belfast
BT126BA
Northern Ireland
United Kingdom

Website	http://www.royalhospitals.org/contacts/index.php
"ROR"	https://ror.org/02tdmfk69

Not defined

Doctoral fellowship scheme, Central Services Agency (UK)

No information available

REVIVE Charity for the regional intensive care unit, the Royal Group of Hospitals Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2014		Yes	No