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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2015-04-23Author
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 AH
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
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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 AH; 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 (2015). 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. Trials 16 ,
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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.
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