Condition category
Respiratory
Date applied
09/03/2007
Date assigned
18/05/2007
Last edited
04/04/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Danny McAuley

ORCID ID

Contact details

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

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 (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

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

http://www.royalhospitals.org/contacts/index.php

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

  1. 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.

Additional files

Editorial Notes