The effect of the arm blood pressure cuff inflations during abdominal aortic aneurysm surgery as a measure of protecting kidney and heart from injury

ISRCTN	ISRCTN11019960
DOI	https://doi.org/10.1186/ISRCTN11019960
Protocol serial number	SVH/AAA/ TR1
Sponsor	St Vincent's University Hospital (Ireland)
Funder	St Vincent's University Hospital (Ireland) - Department of Anaesthesia

Submission date: 23/03/2010
Registration date: 07/06/2010
Last edited: 29/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ajith Vijayan
Scientific

206 Whitecliff
Rathfarnham
Dublin
D16
Ireland

Study information

Primary study design	Interventional
Study design	Single centre two arm double blind randomised controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	St. Vincents Healthcare Group Ethics and Medical Research Committee approved on the 9th March 2009
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Markers of cardiac injury: 1. Cardiac troponin 2. Electrocardiography (ECG) changes Outcomes will be measured for three days following surgery
Completion date	31/03/2013

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	01/07/2009
Date of final enrolment	31/03/2013

Locations

Countries of recruitment

Ireland

Study participating centre

206 Whitecliff

Dublin
D16
Ireland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/10/2014	29/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/01/2019: Publication reference added