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 |
| Secondary identifying numbers | SVH/AAA/ TR1 |
- 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
Scientific
206 Whitecliff
Rathfarnham
Dublin
D16
Ireland
Study information
| Study design | Single centre two arm double blind randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/07/2009 |
| Completion date | 31/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 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
D16
Ireland
Sponsor information
St Vincent's University Hospital (Ireland)
Hospital/treatment centre
Hospital/treatment centre
Department of Anaesthesia
Elm Park
Dublin
D4
Ireland
"ROR" |
https://ror.org/029tkqm80 |
|---|
Funders
Funder type
Hospital/treatment centre
St Vincent's University Hospital (Ireland) - Department of Anaesthesia
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
29/01/2019: Publication reference added
