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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.
Trials. 2015 Apr 23; 16:185.T

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.

Authors+Show Affiliations

Department of Vascular Surgery, University Hospital Limerick, Saint Nessan's Road, Dooradoyle, Limerick, Ireland. Donagh1@hotmail.com.University of Limerick, Castletroy, Limerick, Ireland. Mary.ClarkeMoloney@ul.ie.National Cardiovascular and Stroke Research Network, Irish Heart Foundation, 50 Ringsend Road, Dublin, Ireland. bgaughan@irishheart.ie.National Cardiovascular and Stroke Research Network, Irish Heart Foundation, 50 Ringsend Road, Dublin, Ireland. sodaly@irishheart.ie.The Hatter Cardiovascular Institute, University College London, 67 Chenies Mews, London, WC1E 6HX, UK. d.hausenloy@ucl.ac.uk.NUI Galway, University Road, Galway, Ireland. faisal.sharif@nuigalway.ie.Health Research Board Clinical Research Facility Galway, National University of Ireland, Galway, Geata an Eolais, University Road, Galway, Ireland. john.newell@nuigalway.ie.Health Research Board Clinical Research Facility Galway, National University of Ireland, Galway, Geata an Eolais, University Road, Galway, Ireland. martin.odonnell@nuigalway.ie.University of Limerick, Castletroy, Limerick, Ireland. pagrace@eircom.net.University of Limerick, Castletroy, Limerick, Ireland. John.Forbes@ul.ie.University of Limerick, Castletroy, Limerick, Ireland. walter.cullen@ul.ie.Department of Vascular Surgery, University Hospital Limerick, Saint Nessan's Road, Dooradoyle, Limerick, Ireland. eamon.kavanagh@hse.ie.Department of Vascular Surgery, University Hospital Limerick, Saint Nessan's Road, Dooradoyle, Limerick, Ireland. peburke1@gmail.com.Waterford Regional Hospital, Dunmore Road, Waterford, Ireland. simon.cross@hse.ie.Waterford Regional Hospital, Dunmore Road, Waterford, Ireland. joseph.dowdall@hse.ie.Waterford Regional Hospital, Dunmore Road, Waterford, Ireland. Morgan.McMonagle@hse.ie.Cork University Hospital, Corcaigh, Wilton, Co. Cork, Ireland. Greg.Fulton@hse.ie.Cork University Hospital, Corcaigh, Wilton, Co. Cork, Ireland. brianj.manning@hse.ie.Department of Vascular Surgery, University Hospital Limerick, Saint Nessan's Road, Dooradoyle, Limerick, Ireland. rashmed1111@gmail.com.Beaumont Hospital, Beaumont Road, Dublin 9, Ireland. profaustinleahy@beaumont.ie.Beaumont Hospital, Beaumont Road, Dublin 9, Ireland. daragh.moneley@beaumont.ie.Beaumont Hospital, Beaumont Road, Dublin 9, Ireland. peternaughton74@eircom.net.Department of Vascular Surgery, Beaumont Hospital, Beaumont Road, Dublin 9, Ireland. emboyle@rcsi.ie.Department of Vascular Surgery, Beaumont Hospital, Beaumont Road, Dublin 9, Ireland. seamusmchugh@rcsi.ie.St. James's Hospital, James Street, Dublin 8, Ireland. pmadhaven@stjames.ie.St. James's Hospital, James Street, Dublin 8, Ireland. seanoneillsec@stjames.ie.St. James's Hospital, James Street, Dublin 8, Ireland. zeniamartin@gmail.com.Galway University Hospital, Newcastle Road, Galway, Ireland. donal.courtney@hse.ie.Galway University Hospital, Newcastle Road, Galway, Ireland. muhammed.tubassam@hse.ie.Galway University Hospital, Newcastle Road, Galway, Ireland. sheriff.sultan@hse.ie.Department of Vascular Surgery, Waterford Regional Hospital, Dunmore Road, Waterford, Ireland. damiamccartan@rcsi.ie.Department of Vascular Surgery, Waterford Regional Hospital, Dunmore Road, Waterford, Ireland. mekkimedani@rcsi.ie.Health Research Board Clinical Research Facility Galway, National University of Ireland, Galway, Geata an Eolais, University Road, Galway, Ireland. STEWARTREDMOND.WALSH@nuigalway.ie.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25903752

Citation

Healy, Donagh, et al. "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, vol. 16, 2015, p. 185.
Healy D, Clarke-Moloney M, Gaughan B, et al. 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. 2015;16:185.
Healy, D., Clarke-Moloney, M., Gaughan, B., O'Daly, S., Hausenloy, D., Sharif, F., Newell, J., O'Donnell, M., Grace, P., Forbes, J. F., Cullen, W., Kavanagh, E., Burke, P., Cross, S., Dowdall, J., McMonagle, M., Fulton, G., Manning, B. J., Kheirelseid, E. A., ... Walsh, S. (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, 185. https://doi.org/10.1186/s13063-015-0678-1
Healy D, et al. 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. 2015 Apr 23;16:185. PubMed PMID: 25903752.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Healy,Donagh, AU - Clarke-Moloney,Mary, AU - Gaughan,Brendan, AU - O'Daly,Siobhan, AU - Hausenloy,Derek, AU - Sharif,Faisal, AU - Newell,John, AU - O'Donnell,Martin, AU - Grace,Pierce, AU - Forbes,John F, AU - Cullen,Walter, AU - Kavanagh,Eamon, AU - Burke,Paul, AU - Cross,Simon, AU - Dowdall,Joseph, AU - McMonagle,Morgan, AU - Fulton,Greg, AU - Manning,Brian J, AU - Kheirelseid,Elrasheid A H, AU - Leahy,Austin, AU - Moneley,Daragh, AU - Naughton,Peter, AU - Boyle,Emily, AU - McHugh,Seamus, AU - Madhaven,Prakash, AU - O'Neill,Sean, AU - Martin,Zenia, AU - Courtney,Donal, AU - Tubassam,Muhammed, AU - Sultan,Sherif, AU - McCartan,Damian, AU - Medani,Mekki, AU - Walsh,Stewart, Y1 - 2015/04/23/ PY - 2014/06/09/received PY - 2015/03/25/accepted PY - 2015/4/24/entrez PY - 2015/4/24/pubmed PY - 2016/4/14/medline SP - 185 EP - 185 JF - Trials JO - Trials VL - 16 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/25903752/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0678-1 DB - PRIME DP - Unbound Medicine ER -