Condition category
Circulatory System
Date applied
06/06/2006
Date assigned
17/08/2006
Last edited
17/08/2010
Prospective/Retrospective
Retrospectively 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

Mr Michael Gaunt

ORCID ID

Contact details

Cambridge Vascular Unit
Box 201
Level 7
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0) 1223 217246
michael.gaunt@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Remote ischaemic preconditioning will reduce subclinical renal and myocardial damage following endovascular abdominal aortic aneurysm repair.

Ethics approval

Ethics approval received from the Cambridge Research Ethics Committee on 20th June 2006 (ref: 06/Q0108/127).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Abdominal aortic aneurysm

Intervention

Intervention:
Remote ischaemic preconditioning. After induction of anaesthesia, an inflatable cuff will be used to render each leg ischaemic for ten minutes. The operation will then proceed in the usual fashion.

Control:
The control group will receive usual care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Urinary retinol binding protein levels pre- and post-operatively.

Secondary outcome measures

1. Urinary albumin-creatinine ratios
2. Urinary Tumour Necrosis Factor (TNF), Tumour Necrosis Factor Receptor (TNFR) 1 and TNFR2
3. Serum TNF, TNFR1 and TNFR2
4. Serum creatinine
5. Creatinine clearance
6. Glomerular filtration rate
7. Cardiac index as measured by the LiDCO system
8. Peripheral vascular resistance as measured by the LiDCO system
9. Ischaemia detected on 12-lead electrocardiogram

Overall trial start date

15/06/2006

Overall trial end date

14/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient undergoing elective endovascular repair of an abdominal aortic aneurysm.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Ankle-brachial pressure index less than 0.7
2. Previous renal transplant
3. Previous renal disease
4. Previous renal replacement therapy
5. Previous endovascular aneurysm repair
6. Baseline serum creatinine more than 150 mmols/l
7. Baseline serum urea more than 20 mmols/l
8. Previous lower limb amputation

Recruitment start date

15/06/2006

Recruitment end date

14/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cambridge Vascular Unit
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

c/o Dr John Bradley
Director of Research and Development
Research and Development Office
Box 146
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0) 1223 274486
john.bradley@addenbrookes.nhs.uk

Sponsor type

Government

Website

http://www.addenbrookes.nhs.uk/research

Funders

Funder type

Research organisation

Funder name

Cambridge Vascular Unit Research Fund (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

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19995115
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20484066

Publication citations

  1. Results

    Walsh SR, Boyle JR, Tang TY, Sadat U, Cooper DG, Lapsley M, Norden AG, Varty K, Hayes PD, Gaunt ME, Remote ischemic preconditioning for renal and cardiac protection during endovascular aneurysm repair: a randomized controlled trial., J. Endovasc. Ther., 2009, 16, 6, 680-689, doi: 10.1583/09-2817.1.

  2. Results

    Walsh SR, Sadat U, Boyle JR, Tang TY, Lapsley M, Norden AG, Gaunt ME, Remote ischemic preconditioning for renal protection during elective open infrarenal abdominal aortic aneurysm repair: randomized controlled trial., Vasc Endovascular Surg, 2010, 44, 5, 334-340, doi: 10.1177/1538574410370788.

Additional files

Editorial Notes