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
Secondary identifying numbers	N/A

Submission date: 06/06/2006
Registration date: 17/08/2006
Last edited: 17/08/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	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 study start date	15/06/2006
Completion date	14/06/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	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

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Cambridge Vascular Unit

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Dr John Bradley
Director of Research and Development
Research and Development Office
Box 146
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom

Phone	+44 (0) 1223 274486
Email	john.bradley@addenbrookes.nhs.uk
Website	http://www.addenbrookes.nhs.uk/research
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Research organisation

Cambridge Vascular Unit Research Fund (UK)

No information available

Results and Publications

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

Study outputs

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