Does ischaemic preconditioning reduce adverse events following endovascular repair of abdominal aortic aneurysms? A randomised controlled pilot trial

ISRCTN	ISRCTN61182546
DOI	https://doi.org/10.1186/ISRCTN61182546
Protocol serial number	N/A
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funder	Cambridge Vascular Unit Research Fund (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Michael Gaunt
Scientific

Cambridge Vascular Unit
Box 201, Level 7
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0) 1223 217246
Email	michael.gaunt@addenbrookes.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Remote ischaemic preconditioning will reduce subclinical renal and myocardial damage following endovascular abdominal aortic aneurysm repair.
Ethics approval(s)	Ethics approval received from the Cambridge Research Ethics Committee on 20th June 2006 (ref: 06/Q0108/127).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Urinary retinol binding protein levels pre- and post-operatively.
Key secondary outcome measure(s)	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
Completion date	14/06/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	40
Key inclusion criteria	Any patient undergoing elective endovascular repair of an abdominal aortic aneurysm.
Key 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
Date of first enrolment	15/06/2006
Date of final enrolment	14/06/2007

Cambridge Vascular Unit

Cambridge
CB2 2QQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2009		Yes	No
Results article	results	01/07/2010		Yes	No