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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.

Healy D, Clarke-Moloney M, Gaughan B, O'Daly S, Hausenloy D, Sharif F, Newell J, O'Donnell M, Grace P, Forbes JF, Cullen W, Kavanagh E, Burke P, Cross S, Dowdall J, McMonagle M, Fulton G, Manning BJ, Kheirelseid EA, Leahy A, Moneley D, Naughton P, Boyle E, McHugh S, Madhaven P, O'Neill S, Martin Z, Courtney D, Tubassam M, Sultan S, McCartan D, Medani M, Walsh S - Trials (2015)

Bottom Line: This mechanistic redundancy limits techniques to reduce complications that target individual mechanisms, for example, anti-platelet agents.The primary outcome measure is the proportion of patients who develop elevated serum troponin levels in the first 3 days post-operatively.RIPC is novel intervention with the potential to significantly improve perioperative outcomes.

View Article: PubMed Central - PubMed

Affiliation: Department of Vascular Surgery, University Hospital Limerick, Saint Nessan's Road, Dooradoyle, Limerick, Ireland. Donagh1@hotmail.com.

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.

No MeSH data available.


Related in: MedlinePlus

Participant flow through the trial. AAA – abdominal aortic aneurysm; CEA – carotid endarterectomy; ECG –electrocardiography; EVAR – endovascular abdominal aneurysm repair; PIL – patient information leaflet; RIPC – remote ischaemic preconditioning.
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Fig1: Participant flow through the trial. AAA – abdominal aortic aneurysm; CEA – carotid endarterectomy; ECG –electrocardiography; EVAR – endovascular abdominal aneurysm repair; PIL – patient information leaflet; RIPC – remote ischaemic preconditioning.

Mentions: This is a randomised controlled pilot trial of the effect of RIPC induced by brief arm ischaemia and reperfusion on troponin levels in the first 3 days post-operatively in patients undergoing elective major vascular surgery. Patients are randomised to receive RIPC or act as controls. There is no sham intervention. The primary study endpoint is determined at 3 days post-operatively. Secondary study endpoints are evaluated at 30 days and one year post-operatively. Participant flow through the trial is described in Figure 1.Figure 1


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.

Healy D, Clarke-Moloney M, Gaughan B, O'Daly S, Hausenloy D, Sharif F, Newell J, O'Donnell M, Grace P, Forbes JF, Cullen W, Kavanagh E, Burke P, Cross S, Dowdall J, McMonagle M, Fulton G, Manning BJ, Kheirelseid EA, Leahy A, Moneley D, Naughton P, Boyle E, McHugh S, Madhaven P, O'Neill S, Martin Z, Courtney D, Tubassam M, Sultan S, McCartan D, Medani M, Walsh S - Trials (2015)

Participant flow through the trial. AAA – abdominal aortic aneurysm; CEA – carotid endarterectomy; ECG –electrocardiography; EVAR – endovascular abdominal aneurysm repair; PIL – patient information leaflet; RIPC – remote ischaemic preconditioning.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4414457&req=5

Fig1: Participant flow through the trial. AAA – abdominal aortic aneurysm; CEA – carotid endarterectomy; ECG –electrocardiography; EVAR – endovascular abdominal aneurysm repair; PIL – patient information leaflet; RIPC – remote ischaemic preconditioning.
Mentions: This is a randomised controlled pilot trial of the effect of RIPC induced by brief arm ischaemia and reperfusion on troponin levels in the first 3 days post-operatively in patients undergoing elective major vascular surgery. Patients are randomised to receive RIPC or act as controls. There is no sham intervention. The primary study endpoint is determined at 3 days post-operatively. Secondary study endpoints are evaluated at 30 days and one year post-operatively. Participant flow through the trial is described in Figure 1.Figure 1

Bottom Line: This mechanistic redundancy limits techniques to reduce complications that target individual mechanisms, for example, anti-platelet agents.The primary outcome measure is the proportion of patients who develop elevated serum troponin levels in the first 3 days post-operatively.RIPC is novel intervention with the potential to significantly improve perioperative outcomes.

View Article: PubMed Central - PubMed

Affiliation: Department of Vascular Surgery, University Hospital Limerick, Saint Nessan's Road, Dooradoyle, Limerick, Ireland. Donagh1@hotmail.com.

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.

No MeSH data available.


Related in: MedlinePlus