Condition category
Surgery
Date applied
23/03/2010
Date assigned
07/06/2010
Last edited
18/12/2012
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

Dr Ajith Vijayan

ORCID ID

Contact details

206 Whitecliff
Rathfarnham
Dublin
D16
Ireland

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. Vincent’s 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

Sponsor information

Organisation

St Vincent's University Hospital (Ireland)

Sponsor details

Department of Anaesthesia
Elm Park
Dublin
D4
Ireland

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes