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
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

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

Study information

Study designProspective, randomised, double-blind, placebo-controlled clinical trial and an in vitro study.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymPrevention-HARP
Study objectivesTreatment 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) studiedAcute Lung Injury (ALI)
InterventionPatients will be randomised to simvastatin 80 mg or placebo enterally for 4 days prior to surgery and up to 7 days following surgery.
Intervention typeOther
Primary outcome measureEfficacy of simvastatin to improve pulmonary deadspace at 6 hours following oesophagectomy or prior to extubation if earlier.
Secondary outcome measures1. 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 date01/08/2007
Completion date01/08/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40
Key inclusion criteriaAdult patients undergoing oesophagectomy.
Key exclusion criteria1. 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
Date of first enrolment01/08/2007
Date of final enrolment01/08/2010

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Intensive Care Unit
Belfast
BT12 6BA
United Kingdom

Sponsor information

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 logo "ROR" https://ror.org/02tdmfk69

Funders

Funder type

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

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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