糖皮质激素在低温停循环手术中应用的多中心研究的前期调查
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摘要
目的了解甲基泼尼松龙在低温停循环手术中应用的多中心随机安慰剂对照试验(SMART)各子中心主动脉全弓置换术(TAR)术中糖皮质激素的应用现状、终点指标发生率以及体外循环管理策略的异同,为SMART试验和国内其它中心研究的开展提供依据。方法向9个中心的SMART研究负责人发放SMART试验前期调查问卷,包括围术期激素应用的种类、剂量和时机、终点指标的发生率和体外循环管理策略(涉及温度管理、选择性脑灌注和神经保护药物)。结果 9个中心TAR手术术后30天死亡率为2.3%～8%,糖皮质激素使用存在差异,体外循环管理普遍采取下半身中低温停循环+选择性脑灌注的策略,脑灌注的方式及监测手段、温度管理、神经保护药物的用药剂量时机也存在差异。结论甲基泼尼松龙在低温停循环手术中的应用存在差异,本研究可作为SMART研究实验设计、样本量计算、终点指标选取的依据。
Objective To investigate current practice of glucocorticoids application,incidence of endpoints and strategies of cardiopulmonary bypass management during total arch replacement in centers participating in methylpredni Solone in hypother Mic circul Atory aRrest s Tudy( SMART) to establish a basis for SMART and other multi-center studies in future. Methods The pilot study questionnaire was designed and sent to leaders of the nine centers of SMART,including information on glucocorticoids application,incidence of endpoints and strategies of cardiopulmonary bypass management( temperature management strategy,selective cerebral perfusion and neuroprotective drugs) during total arch replacement. Results The 30-day mortality in the participating centers ranged from2.5% to 8%. Moderate hypothermic circulatory arrest and selective cerebral perfusion were generally applied. The utilization of methylprednisolone varied. Conclusion There was controversy in utilization of glucocorticoid in total arch replacement surgery with hypothermic circulatory arrest. The study provided basis of the trial design,sample size calculation,and endpoints selection of the SMART study.
Objective To investigate current practice of glucocorticoids application,incidence of endpoints and strategies of cardiopulmonary bypass management during total arch replacement in centers participating in methylpredni Solone in hypother Mic circul Atory aRrest s Tudy( SMART) to establish a basis for SMART and other multi-center studies in future. Methods The pilot study questionnaire was designed and sent to leaders of the nine centers of SMART,including information on glucocorticoids application,incidence of endpoints and strategies of cardiopulmonary bypass management( temperature management strategy,selective cerebral perfusion and neuroprotective drugs) during total arch replacement. Results The 30-day mortality in the participating centers ranged from2.5% to 8%. Moderate hypothermic circulatory arrest and selective cerebral perfusion were generally applied. The utilization of methylprednisolone varied. Conclusion There was controversy in utilization of glucocorticoid in total arch replacement surgery with hypothermic circulatory arrest. The study provided basis of the trial design,sample size calculation,and endpoints selection of the SMART study.
引文
[1] Nienaber CA,Clough RE. Management of acute aortic dissection[J]. Lancet,2015,385(9970):800-811.
[2] Tsagakis K,Dohle D,Benedik J,et al. Overall essen's experience with the e-vita open hybrid stent graft system and evolution of the surgical technique[J]. Ann Cardiothorac Surg,2013,2(5):612-620.
[3] Cefarelli M,Murana G,Surace GG,et al. Elective aortic arch repair:factors influencing neurologic outcome in 791 patients[J].Ann Thorac Surg,2017,104(6):2016-2023.
[4] Lee TC,Kon Z,Cheema FH,et al. Contemporary management and outcomes of acute type a aortic dissection:an analysis of the STS adult cardiac surgery database[J]. J Card Surg,2018,33(1):7-18.
[5] Damberg A,Carino D,Charilaou P,et al. Favorable late survival after aortic surgery under straight deep hypothermic circulatory arrest[J]. J Thorac Cardiovasc Surg,2017,154(6):1831-1839.
[6] Augoustides JG,Patel P,Ghadimi K,et al. Current conduct of deep hypothermic circulatory arrest in china[J]. HSR Proc Intensive Care Cardiovasc Anesth,2013,5(1):25-32.
[7] Gutsche JT,Feinman J,Silvay G,et al. Practice variations in the conduct of hypothermic circulatory arrest for adult aortic arch repair:focus on an emerging european paradigm[J]. Heart Lung Vessel,2014,6(1):43-51.
[8] Shum-Tim D,Tchervenkov CI,Jamal AM,et al. Systemic steroid pretreatment improves cerebral protection after circulatory arrest[J]. Ann Thorac Surg,2001,72(5):1465-1471.
[9] Woloszyn TT,Marini CP,Coons MS,et al. Cerebrospinal fluid drainage and steroids provide better spinal cord protection during aortic cross-clamping than does either treatment alone[J]. Ann Thorac Surg,1990,49(1):78-82.
[10] Krüger T,Hoffmann I,Blettner M,et al. Intraoperative neuroprotective drugs without beneficial effects? results of the german registry for acute aortic dissection type a(GERAADA)[J]. Eur J Cardiothorac Surg,2013,44(5):939-946.
[11] Whitlock RP,Devereaux PJ,Teoh KH,et al. Methylprednisolone in patients undergoing cardiopulmonary bypass(SIRS):a randomised,double-blind,placebo-controlled trial[J]. Lancet,2015,386(10000):1243-1253.
[12] Guo S,Sun Y,Ji B,et al. Similar cerebral protective effectiveness of antegrade and retrograde cerebral perfusion during deep hypothermic circulatory arrest in aortic surgery:a meta-analysis of7023 patients[J]. Artif Organs,2015,39(4):300-308.
[13] Englum BR,He X,Gulack BC,et al. Hypothermia and cerebral protection strategies in aortic arch surgery:a comparative effectiveness analysis from the STS adult cardiac surgery database[J]. Eur J Cardiothorac Surg,2017,52(3):492-498.
[14] Tian DH,Wan B,Bannon PG,et al,A meta-analysis of deep hypothermic circulatory arrest alone versus with adjunctive selective antegrade cerebral perfusion[J]. Ann Cardiothorac Surg,2013,2(3):261-270.
[15] Keeling WB,Tian DH,Leshnower BG,et al. Safety of moderate hypothermia with antegrade cerebral perfusion in total aortic arch replacement[J]. Ann Thorac Surg,2018,105(1):54-61.
[16] Preventza O,Simpson KH,Cooley DA,et al. Unilateral versus bilateral cerebral perfusion for acute type A aortic dissection[J]?Ann Thorac Surg,2015,99(1):80-87.
[17] Zierer A,Risteski P,El-Sayed Ahmad A,et al. The impact of unilateral versus bilateral antegrade cerebral perfusion on surgical outcomes after aortic arch replacement:a propensity-matched analysis[J]. J Thorac Cardiovasc Surg,2014,147(4):1212-1217.
[18] Vranken NPA,Weerwind PW,Sutedja NA,et al. Cerebral oximetry and autoregulation during cardiopulmonary bypass:a review[J]. J Extra Corpor Technol,2017,49(3):182-191.
[19] Moerman A,De Hert S. Recent advances in cerebral oximetry. assessment of cerebral autoregulation with near-infrared spectroscopy:myth or reality[J]? F1000Res,2017,6:1615.
[20] Engelman R,Baker RA,Likosky DS,et al. The society of thoracic surgeons,The society of cardiovascular anesthesiologists,and the american society of extra corporeal technology:clinical practice guidelines for cardiopulmonary bypass--temperature management during cardiopulmonary bypass[J]. Ann Thorac Surg,2015,100(2):748-757.
[2] Tsagakis K,Dohle D,Benedik J,et al. Overall essen's experience with the e-vita open hybrid stent graft system and evolution of the surgical technique[J]. Ann Cardiothorac Surg,2013,2(5):612-620.
[3] Cefarelli M,Murana G,Surace GG,et al. Elective aortic arch repair:factors influencing neurologic outcome in 791 patients[J].Ann Thorac Surg,2017,104(6):2016-2023.
[4] Lee TC,Kon Z,Cheema FH,et al. Contemporary management and outcomes of acute type a aortic dissection:an analysis of the STS adult cardiac surgery database[J]. J Card Surg,2018,33(1):7-18.
[5] Damberg A,Carino D,Charilaou P,et al. Favorable late survival after aortic surgery under straight deep hypothermic circulatory arrest[J]. J Thorac Cardiovasc Surg,2017,154(6):1831-1839.
[6] Augoustides JG,Patel P,Ghadimi K,et al. Current conduct of deep hypothermic circulatory arrest in china[J]. HSR Proc Intensive Care Cardiovasc Anesth,2013,5(1):25-32.
[7] Gutsche JT,Feinman J,Silvay G,et al. Practice variations in the conduct of hypothermic circulatory arrest for adult aortic arch repair:focus on an emerging european paradigm[J]. Heart Lung Vessel,2014,6(1):43-51.
[8] Shum-Tim D,Tchervenkov CI,Jamal AM,et al. Systemic steroid pretreatment improves cerebral protection after circulatory arrest[J]. Ann Thorac Surg,2001,72(5):1465-1471.
[9] Woloszyn TT,Marini CP,Coons MS,et al. Cerebrospinal fluid drainage and steroids provide better spinal cord protection during aortic cross-clamping than does either treatment alone[J]. Ann Thorac Surg,1990,49(1):78-82.
[10] Krüger T,Hoffmann I,Blettner M,et al. Intraoperative neuroprotective drugs without beneficial effects? results of the german registry for acute aortic dissection type a(GERAADA)[J]. Eur J Cardiothorac Surg,2013,44(5):939-946.
[11] Whitlock RP,Devereaux PJ,Teoh KH,et al. Methylprednisolone in patients undergoing cardiopulmonary bypass(SIRS):a randomised,double-blind,placebo-controlled trial[J]. Lancet,2015,386(10000):1243-1253.
[12] Guo S,Sun Y,Ji B,et al. Similar cerebral protective effectiveness of antegrade and retrograde cerebral perfusion during deep hypothermic circulatory arrest in aortic surgery:a meta-analysis of7023 patients[J]. Artif Organs,2015,39(4):300-308.
[13] Englum BR,He X,Gulack BC,et al. Hypothermia and cerebral protection strategies in aortic arch surgery:a comparative effectiveness analysis from the STS adult cardiac surgery database[J]. Eur J Cardiothorac Surg,2017,52(3):492-498.
[14] Tian DH,Wan B,Bannon PG,et al,A meta-analysis of deep hypothermic circulatory arrest alone versus with adjunctive selective antegrade cerebral perfusion[J]. Ann Cardiothorac Surg,2013,2(3):261-270.
[15] Keeling WB,Tian DH,Leshnower BG,et al. Safety of moderate hypothermia with antegrade cerebral perfusion in total aortic arch replacement[J]. Ann Thorac Surg,2018,105(1):54-61.
[16] Preventza O,Simpson KH,Cooley DA,et al. Unilateral versus bilateral cerebral perfusion for acute type A aortic dissection[J]?Ann Thorac Surg,2015,99(1):80-87.
[17] Zierer A,Risteski P,El-Sayed Ahmad A,et al. The impact of unilateral versus bilateral antegrade cerebral perfusion on surgical outcomes after aortic arch replacement:a propensity-matched analysis[J]. J Thorac Cardiovasc Surg,2014,147(4):1212-1217.
[18] Vranken NPA,Weerwind PW,Sutedja NA,et al. Cerebral oximetry and autoregulation during cardiopulmonary bypass:a review[J]. J Extra Corpor Technol,2017,49(3):182-191.
[19] Moerman A,De Hert S. Recent advances in cerebral oximetry. assessment of cerebral autoregulation with near-infrared spectroscopy:myth or reality[J]? F1000Res,2017,6:1615.
[20] Engelman R,Baker RA,Likosky DS,et al. The society of thoracic surgeons,The society of cardiovascular anesthesiologists,and the american society of extra corporeal technology:clinical practice guidelines for cardiopulmonary bypass--temperature management during cardiopulmonary bypass[J]. Ann Thorac Surg,2015,100(2):748-757.