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

Hdl Handle:
http://hdl.handle.net/10147/574893
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
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
Citation:
Trials. 2015 Apr 23;16(1):185
Issue Date:
23-Apr-2015
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
Language:
en
Keywords:
SURGERY; RISK

Full metadata record

DC FieldValue Language
dc.contributor.authorHealy, Donaghen
dc.contributor.authorClarke-Moloney, Maryen
dc.contributor.authorGaughan, Brendanen
dc.contributor.authorO’Daly, Siobhanen
dc.contributor.authorHausenloy, Dereken
dc.contributor.authorSharif, Faisalen
dc.contributor.authorNewell, Johnen
dc.contributor.authorO’Donnell, Martinen
dc.contributor.authorGrace, Pierceen
dc.contributor.authorForbes, John Fen
dc.contributor.authorCullen, Walteren
dc.contributor.authorKavanagh, Eamonen
dc.contributor.authorBurke, Paulen
dc.contributor.authorCross, Simonen
dc.contributor.authorDowdall, Josephen
dc.contributor.authorMcMonagle, Morganen
dc.contributor.authorFulton, Gregen
dc.contributor.authorManning, Brian Jen
dc.contributor.authorKheirelseid, Elrasheid Aen
dc.contributor.authorLeahy, Austinen
dc.contributor.authorMoneley, Daraghen
dc.contributor.authorNaughton, Peteren
dc.contributor.authorBoyle, Emilyen
dc.contributor.authorMcHugh, Seamusen
dc.contributor.authorMadhaven, Prakashen
dc.contributor.authorO’Neill, Seanen
dc.contributor.authorMartin, Zeniaen
dc.contributor.authorCourtney, Donalen
dc.contributor.authorTubassam, Muhammeden
dc.contributor.authorSultan, Sherifen
dc.contributor.authorMcCartan, Damianen
dc.contributor.authorMedani, Mekkien
dc.contributor.authorWalsh, Stewarten
dc.date.accessioned2015-08-17T14:09:42Zen
dc.date.available2015-08-17T14:09:42Zen
dc.date.issued2015-04-23en
dc.identifier.citationTrials. 2015 Apr 23;16(1):185en
dc.identifier.urihttp://dx.doi.org/10.1186/s13063-015-0678-1en
dc.identifier.urihttp://hdl.handle.net/10147/574893en
dc.description.abstractAbstract 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 2014en
dc.language.isoenen
dc.subjectSURGERYen
dc.subjectRISKen
dc.titlePreconditioning 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 trialen
dc.language.rfc3066enen
dc.rights.holderHealy et al.; licensee BioMed Central.en
dc.date.updated2015-08-14T13:21:47Zen
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