Does ischaemic pre-conditioning reduce renal damage during elective infra-renal aortic aneurysm repair? Randomised controlled trial.

ISRCTN	ISRCTN89918035
DOI	https://doi.org/10.1186/ISRCTN89918035
Protocol serial number	05/Q0108/276 - NRR ref N0544174223
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funder	Cambridge Vascular Unit's own in-house research fund. This is not a trust own account or an NHS R&D funded project.

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

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

Phone	+44 (0)1223 216992
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	Ischaemic preconditioning during open infra-renal aortic aneurysm repair will reduce intra-operative renal damage.
Ethics approval(s)	The trial has been reviewed and approved by the Cambridgeshire Research Ethics Committee, October 2005. REC reference number 05/Q0108/276.
Health condition(s) or problem(s) studied	Abdominal aortic aneurysm
Intervention	Participants will be randomised to undergo clamping or not. The intervention consists of application of a crossclamp to each common iliac artery for 10 minutes followed by 10 minutes reperfusion time during the dissection phase of the operation. Each common iliac artery will be clamped in sequence not simultaneously. The temporary interruption to blood flow in the leg provides an ischaemic stimulus that appears to protect the heart from damage during the operation. This trial aims to determine if the same technique protects the kidneys.
Intervention type	Other
Primary outcome measure(s)	1. Post-operative urinary albumin-creatinine ratios 2. Post-operative creatinine clearance 3. Post-operative glomerular filtration rate
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	14/11/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key inclusion criteria	Patients undergoing elective open repair of an infra-renal abdominal aortic aneurysm.
Key exclusion criteria	1. Pre-existing renal failure 2. Baseline serum creatinine >150 µmols/l 3. Baseline serum urea >20 mmols/l 4. Previous history of acute renal failure 5. Previous renal transplant 6. Previous renal disease 7. Previous endovascular aneurysm repair 8. Previous renal replacement therapy 9. Suprarenal aneurysm 10. Ankle-brachial pressure index <0.7
Date of first enrolment	14/11/2005
Date of final enrolment	14/11/2006

Consultant Vascular Surgeon

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	01/07/2010		Yes	No