Condition category
Circulatory System
Date applied
02/11/2005
Date assigned
15/11/2005
Last edited
16/12/2010
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

Consultant Vascular Surgeon
Cambridge Vascular Unit
Box 201 Level 7
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 216992
michael.gaunt@addenbrookes.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05/Q0108/276 - NRR ref N0544174223

Study information

Scientific title

Acronym

Study hypothesis

Ischaemic preconditioning during open infra-renal aortic aneurysm repair will reduce intra-operative renal damage.

Ethics approval

The trial has been reviewed and approved by the Cambridgeshire Research Ethics Committee, October 2005. REC reference number 05/Q0108/276.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

1. Post-operative urinary albumin-creatinine ratios
2. Post-operative creatinine clearance
3. Post-operative glomerular filtration rate

Secondary outcome measures

No secondary outcome measures

Overall trial start date

14/11/2005

Overall trial end date

14/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing elective open repair of an infra-renal abdominal aortic aneurysm.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

14/11/2005

Recruitment end date

14/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Vascular Surgeon
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Dr John Bradley
Director of R&D
R&D Office
Box 146
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
+44 (0)1223 274486
joanne.heritage@addenbrookes.nhs.uk

Sponsor type

Government

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

Cambridge Vascular Unit's own in-house research fund. This is not a trust own account or an NHS R&D funded project.

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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20484066

Publication citations

  1. 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