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Preconditioning shields against vascular events in surgery (SAVES), a multicentre feasibility trial of preconditioning against adverse events in major vascular surgery: study protocol for a randomised control trial

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dc.contributor.author Healy, Donagh A.
dc.contributor.author Clarke-Moloney, Mary
dc.contributor.author Gaughan, Brendan
dc.contributor.author O'Daly, Siobhan
dc.contributor.author Hausenloy, Derek
dc.contributor.author Sharif, Faisal
dc.contributor.author Newell, John
dc.contributor.author O'Donnell, Martin
dc.contributor.author Grace, Pierce
dc.contributor.author Forbes, John F.
dc.contributor.author Cullen, Walter
dc.contributor.author Kavanagh, Eamon G.
dc.contributor.author Burke, Paul E.
dc.contributor.author Cross, Simon
dc.contributor.author Dowdall, Joseph
dc.contributor.author McMonagle, Morgan
dc.contributor.author Fulton, Greg J.
dc.contributor.author Manning, Brian J
dc.contributor.author Kheirelseid, Elrasheid A. H.
dc.contributor.author Leahy, Austin
dc.contributor.author Moneley, Daragh
dc.contributor.author Naughton, Peter
dc.contributor.author Boyle, Emily
dc.contributor.author McHugh, Seamus
dc.contributor.author Madhaven, Prakash
dc.contributor.author O'Neill, Sean
dc.contributor.author Martin, Zenia
dc.contributor.author Courtney, Donal
dc.contributor.author Tubassam, Muhammed
dc.contributor.author Sultan, Sherif
dc.contributor.author McCartan, Damian
dc.contributor.author Medani, Mekki
dc.contributor.author Walsh, Stewart R.
dc.date.accessioned 2015-09-07T14:19:55Z
dc.date.available 2015-09-07T14:19:55Z
dc.date.issued 2015
dc.identifier.uri http://hdl.handle.net/10344/4614
dc.description peer-reviewed en_US
dc.description.abstract Background: Patients undergoing vascular surgery procedures constitute a 'high-risk' group. Fatal and disabling perioperative complications are common. Complications arise via multiple aetiological pathways. This mechanistic redundancy limits techniques to reduce complications that target individual mechanisms, for example, anti-platelet agents. Remote ischaemic preconditioning (RIPC) induces a protective phenotype in at-risk tissue, conferring protection against ischaemia-reperfusion injury regardless of the trigger. RIPC is induced by repeated periods of upper limb ischaemia-reperfusion produced using a blood pressure cuff. RIPC confers some protection against cardiac and renal injury during major vascular surgery in proof-of-concept trials. Similar trials suggest benefit during cardiac surgery. Several uncertainties remain in advance of a full-scale trial to evaluate clinical efficacy. We propose a feasibility trial to fully evaluate arm-induced RIPC's ability to confer protection in major vascular surgery, assess the incidence of a proposed composite primary efficacy endpoint and evaluate the intervention's acceptability to patients and staff.Methods/Design: Four hundred major vascular surgery patients in five Irish vascular centres will be randomised (stratified for centre and procedure) to undergo RIPC or not immediately before surgery. RIPC will be induced using a blood pressure cuff with four cycles of 5 minutes of ischaemia followed by 5 minutes of reperfusion immediately before the start of operations. There is no sham intervention. Participants will undergo serum troponin measurements preoperatively and 1, 2, and 3 days post-operatively. Participants will undergo 12-lead electrocardiograms pre-operatively and on the second post-operative day. Predefined complications within one year of surgery will be recorded. Patient and staff experiences will be explored using qualitative techniques. The primary outcome measure is the proportion of patients who develop elevated serum troponin levels in the first 3 days post-operatively. Secondary outcome measures include length of hospital and critical care stay, unplanned critical care admissions, death, myocardial infarction, stroke, mesenteric ischaemia and need for renal replacement therapy (within 30 days of surgery).Discussion: RIPC is novel intervention with the potential to significantly improve perioperative outcomes. This trial will provide the first evaluation of RIPC's ability to reduce adverse clinical events following major vascular surgery. en_US
dc.language.iso eng en_US
dc.publisher BioMed Central en_US
dc.relation.ispartofseries Trials;16, 185
dc.subject remote preconditioning en_US
dc.subject vascular surgery en_US
dc.subject perioperative complications en_US
dc.subject noncardiac surgery en_US
dc.subject bypass graft-surgery en_US
dc.subject cardiac protection en_US
dc.subject risk en_US
dc.title Preconditioning shields against vascular events in surgery (SAVES), a multicentre feasibility trial of preconditioning against adverse events in major vascular surgery: study protocol for a randomised control trial en_US
dc.type info:eu-repo/semantics/article en_US
dc.type.supercollection all_ul_research en_US
dc.type.supercollection ul_published_reviewed en_US
dc.date.updated 2015-09-07T13:53:28Z
dc.description.version PUBLISHED
dc.identifier.doi 10.1186/s13063-015-0678-1
dc.contributor.sponsor HRB en_US
dc.rights.accessrights info:eu-repo/semantics/openAccess en_US
dc.internal.rssid 1584813
dc.internal.copyrightchecked Yes
dc.description.status peer-reviewed


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