Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SVH/AAA/ TR1
Study information
Scientific title
The effect of the arm blood pressure cuff inflations during open abdominal aortic aneurysm surgery as a measure of protecting kidney and heart from injury: a double-blinded, randomised controlled trial
Acronym
Study hypothesis
Remote ischaemic preconditioning using upper arm blood pressure cuff will significantly reduce renal and myocardial injury following open Abdominal Aortic Anuerysm (AAA) repair.
As of 23/11/2010 this record has been updated to include an amended anticipated end date; the initial end date at the time of registration was 30/06/2011.
Please note that as of 18/12/2012, the anticipated end date has been updated from 30/06/2012 to 31/03/2013.
Further reading
1. http://www.ncbi.nlm.nih.gov/pubmed/15337028
Halkos ME, Kerendi F, Corvera JS, Wang NP, Kin H, Payne CS, Sun HY, Guyton RA, Vinten-Johansen J, Zhao ZQ. Myocardial protection with postconditioning is not enhanced by ischemic preconditioning. Ann Thorac Surg. 2004;78:961-969.
2. http://www.ncbi.nlm.nih.gov/pubmed/15793629
Vinten-Johansen J, Zhao ZQ, Zatta AJ, Kin H, Halkos ME, Kerendi F. Postconditioning: a new link in nature's armor against myocardial ischemia-reperfusion injury. Basic Res Cardiol. 2005;100:295-310.
3. http://www.ncbi.nlm.nih.gov/pubmed/18649981
Wagener G, Gubitosa G, Wang S, Borregaard N, Kim M, Lee HT. Urinary neutrophil gelatinase-associated lipocalin and acute kidney injury after cardiac surgery. Am J Kidney Dis. 2008;52:425- 433
4. http://www.ncbi.nlm.nih.gov/pubmed/14506302
Yellon DM, Downey JM. Preconditioning the myocardium: from cellular physiology to clinical cardiology. Physiol Rev. 2003;83:1113-1151.
5. http://www.ncbi.nlm.nih.gov/pubmed/16258568
Yellon DM, Hausenloy DJ. Realizing the clinical potential of ischemic preconditioning and postconditioning. Nat Clin Pract Cardiovasc Med. 2005;2:568-575.
6. http://www.ncbi.nlm.nih.gov/pubmed/12860564
Zhao ZQ, Corvera JS, Halkos ME, Kerendi F, Wang NP, Guyton RA, Vinten-Johansen J. Inhibition of myocardial injury by ischemic postconditioning during reperfusion: comparison with ischemic preconditioning. Am J Physiol Heart Circ Physiol. 2003;285:H579-H588.
Ethics approval
St. Vincents Healthcare Group Ethics and Medical Research Committee approved on the 9th March 2009
Study design
Single centre two arm double blind randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Abdominal aortic aneurysm surgery
Intervention
Three cycles of upper arm blood pressure cuff inflations 20 mmHg above the baseline, sustained inflation for 5 minutes, deflation for 5 minutes
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Markers of renal injury
1. Urine Neutrophil Gelatinase Associated Lipocalin (NGAL)
2. Creatinine clearance
3. Serum creatinine levels
Outcomes will be measured for three days following surgery
Secondary outcome measures
Markers of cardiac injury:
1. Cardiac troponin
2. Electrocardiography (ECG) changes
Outcomes will be measured for three days following surgery
Overall trial start date
01/07/2009
Overall trial end date
31/03/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. All patients scheduled for elective or urgent abdominal aneurysm repair
2. Leaking abdominal aneurysm can be taken as long as it is haemodynamically stable
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. AAA rupture, unstable haemodynamics
2. Kidney Disease - Risk Injury Failure Loss End-Stage Kidney Disease (RIFLE) class failure, needing Renal Replacement Therapy (RRT)
3. Upper limb vascular insufficiency
4. Recent Myocardial infarction, less than two weeks
Recruitment start date
01/07/2009
Recruitment end date
31/03/2013
Locations
Countries of recruitment
Ireland
Trial participating centre
206 Whitecliff
Dublin
D16
Ireland
Funders
Funder type
Hospital/treatment centre
Funder name
St Vincent's University Hospital (Ireland) - Department of Anaesthesia
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