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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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    Authors
    Healy, Donagh
    Clarke-Moloney, Mary
    Gaughan, Brendan
    O’Daly, Siobhan
    Hausenloy, Derek
    Sharif, Faisal
    Newell, John
    O’Donnell, Martin
    Grace, Pierce
    Forbes, John F
    Cullen, Walter
    Kavanagh, Eamon
    Burke, Paul
    Cross, Simon
    Dowdall, Joseph
    McMonagle, Morgan
    Fulton, Greg
    Manning, Brian J
    Kheirelseid, Elrasheid A
    Leahy, Austin
    Moneley, Daragh
    Naughton, Peter
    Boyle, Emily
    McHugh, Seamus
    Madhaven, Prakash
    O’Neill, Sean
    Martin, Zenia
    Courtney, Donal
    Tubassam, Muhammed
    Sultan, Sherif
    McCartan, Damian
    Medani, Mekki
    Walsh, Stewart
    Show allShow less
    Issue Date
    2015-04-23
    Keywords
    SURGERY
    RISK
    
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    Citation
    Trials. 2015 Apr 23;16(1):185
    URI
    http://dx.doi.org/10.1186/s13063-015-0678-1
    http://hdl.handle.net/10147/574893
    Abstract
    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 pre-operatively 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. Trial Registration www.clinicaltrials.gov NCT02097186 Date Registered: 24 March 2014
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    en
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