升高的基线血清肌酐和身体成分对心脏手术中急性肾损伤的影响 (InCreAS)
升高的基线血清肌酐和身体成分对心脏手术中急性肾损伤的影响 - InCreAS 试验
急性肾损伤 (AKI) 是一种罕见但主要且公认的心脏手术并发症。 最近的研究表明,即使是血清肌酐的微小增加也与死亡风险、住院时间和费用的增加有关。 此外,还显示了基线血清肌酐的截止值及其对心脏手术后死亡率的影响。
在这项研究中,研究人员想要测试增加的 bSCr 是否受身体成分的影响。 此外,研究人员想要确定 AKI 的发生率在低于或高于估计截止值的患者中是否不同。 因此,研究人员希望进行前瞻性队列分析,并将采用其他几个身体成分和营养参数来测试它们对 bSCr 预测能力的影响。 此外,研究人员希望评估几种新的 AKI 生物标志物对心脏手术患者的预测作用。
研究概览
地位
条件
详细说明
急性肾损伤 (AKI) 是一种罕见但主要且公认的心脏手术并发症 (1, 2)。 其发生率为 1% 至 30% (3)。 许多术前、术中和术后因素都与心脏手术后 AKI 的发生有关 (3-19)。 最常用的定义是绝对血清肌酐水平、其在一周内的变化和/或以前未透析的患者是否需要透析 (1, 3-5, 9-11, 19-25)。 在年龄较大、肥胖程度较高的 2 型糖尿病和高血压患者中,人们越来越关注慢性肾病对心血管系统的影响 (26)。 最近的研究表明,即使是血清肌酐的微小增加也与死亡风险、住院时间和费用的增加有关 (27, 28)。 急性透析质量倡议小组将他们的风险、损伤、失败、肾功能丧失、终末期肾脏疾病标准及其对急性肾损伤网络标准的修改对 AKI 的定义进行了标准化 (19, 29, 30)。 这两个标准都需要一个基线血清肌酐值来进行估计 (31)。
在最近发表的一项研究中 (32),显示了基线血清肌酐的截断值及其对心脏手术后死亡率的影响。 在稳态和稳定的肾功能下,SCr 通常由身体根据肌肉质量的绝对量以相对恒定的速率产生,并且是肾功能的可靠且具有成本效益的替代指标 (33)。 SCr 与体重、全身水分和人体测量估计的去脂体重 (LBM) 密切相关 (34)。 大约一半的 LBM 由骨骼肌质量组成 (35)。 最近的研究表明,较高的肌肉质量与 CKD 和其他慢性疾病患者的长寿有关 (36, 37)。 然而,SCr 有一些局限性,例如与年龄、性别、肌肉质量相关的浓度变化,并受膳食蛋白质摄入量的影响。 (38) 此外,AKI 影响不同的复杂细胞和分子通路。 几种新型尿液生物标志物,如胰岛素样生长因子结合蛋白 7 (IGFBP7)、金属蛋白酶组织抑制剂 2 (TIMP-2) 和中性内肽酶 (NEP) 参与细胞损伤的早期阶段,并预测两者的发展AKI 的严重程度和心脏手术后早期的肾脏恢复 (39-43) 在这项研究中,研究人员想要测试增加的 bSCr 是否受身体成分的影响。 此外,研究人员想要确定 AKI 的发生率在低于或高于估计截止值的患者中是否不同。 因此,研究人员希望进行前瞻性队列分析,并将采用其他几个身体成分和营养参数来测试它们对 bSCr 预测能力的影响。 此外,研究人员希望评估几种新的 AKI 生物标志物对心脏手术患者的预测作用。
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Vienna、奥地利、1090
- Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
纳入标准:
- 选择性心脏外科手术
排除标准:
- 紧急程序
- 心脏移植
- 选择性左心室辅助装置 (LVAD) 植入 o 肺动脉血栓切除术
- 拒绝知情同意
- 年龄 < 18 岁
- 怀孕的女人
- 术前肾脏替代治疗 (RRT)
学习计划
研究是如何设计的?
设计细节
- 观测模型:其他
- 时间观点:预期
队列和干预
团体/队列 |
|---|
|
低铬
血清肌酐低于或等于 1.3mg/dL 的患者
|
|
高SCr
血清肌酐高于 1.3mg/dL 的患者
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
身体成分对基线血清肌酐升高的影响
大体时间:7天
|
身体成分将通过生物电阻抗分析、体重、肌肉状况和营养状况进行测量
|
7天
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
基线血清肌酐升高对心脏手术后急性肾损伤差异的影响
大体时间:7天
|
急性肾损伤将由当前的 KDIGO 急性肾损伤指南定义
|
7天
|
|
中性肽链内切酶对急性肾损伤水平的影响
大体时间:7天
|
使用 ELISA 检测尿液中的中性肽链内切酶
|
7天
|
|
右心室功能对急性肾损伤的影响
大体时间:7天
|
右心室功能将通过三尖瓣环平面收缩偏移 (TAPSE) 测量进行评估
|
7天
|
|
ICU住院时间
大体时间:7天
|
7天
|
|
|
30天死亡率
大体时间:30天
|
30天
|
|
|
音量状态
大体时间:7天
|
需要晶体、胶体和血液制品
|
7天
|
|
Podocin对急性肾损伤水平的影响
大体时间:7天
|
Podocin 将通过 ELISA 检测尿液中的 Podocin
|
7天
|
|
Nephrin对急性肾损伤水平的影响
大体时间:7天
|
Nephrin 将通过 ELISA 检测尿液中的肾上腺素
|
7天
|
合作者和调查者
调查人员
- 首席研究员:Martin H Bernardi, Dr.、Divison of Cardiothoracic Anaesthesia and Intensive Care, Medical University of Vienna
出版物和有用的链接
一般刊物
- Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.
- Ostermann ME, Taube D, Morgan CJ, Evans TW. Acute renal failure following cardiopulmonary bypass: a changing picture. Intensive Care Med. 2000 May;26(5):565-71. doi: 10.1007/s001340051205.
- Chertow GM, Levy EM, Hammermeister KE, Grover F, Daley J. Independent association between acute renal failure and mortality following cardiac surgery. Am J Med. 1998 Apr;104(4):343-8. doi: 10.1016/s0002-9343(98)00058-8.
- Mangano CM, Diamondstone LS, Ramsay JG, Aggarwal A, Herskowitz A, Mangano DT. Renal dysfunction after myocardial revascularization: risk factors, adverse outcomes, and hospital resource utilization. The Multicenter Study of Perioperative Ischemia Research Group. Ann Intern Med. 1998 Feb 1;128(3):194-203. doi: 10.7326/0003-4819-128-3-199802010-00005.
- Bahar I, Akgul A, Ozatik MA, Vural KM, Demirbag AE, Boran M, Tasdemir O. Acute renal failure following open heart surgery: risk factors and prognosis. Perfusion. 2005 Oct;20(6):317-22. doi: 10.1191/0267659105pf829oa.
- Janssen DP, Noyez L, van Druten JA, Skotnicki SH, Lacquet LK. Predictors of nephrological morbidity after coronary artery bypass surgery. Cardiovasc Surg. 2002 Jun;10(3):222-7. doi: 10.1016/s0967-2109(01)00134-x.
- Aronson S, Boisvert D, Lapp W. Isolated systolic hypertension is associated with adverse outcomes from coronary artery bypass grafting surgery. Anesth Analg. 2002 May;94(5):1079-84, table of contents. doi: 10.1097/00000539-200205000-00005.
- Aronson S, Fontes ML, Miao Y, Mangano DT; Investigators of the Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation. Risk index for perioperative renal dysfunction/failure: critical dependence on pulse pressure hypertension. Circulation. 2007 Feb 13;115(6):733-42. doi: 10.1161/CIRCULATIONAHA.106.623538. Epub 2007 Feb 5.
- Mangano DT, Tudor IC, Dietzel C; Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation. The risk associated with aprotinin in cardiac surgery. N Engl J Med. 2006 Jan 26;354(4):353-65. doi: 10.1056/NEJMoa051379.
- Gaudino M, Luciani N, Giungi S, Caradonna E, Nasso G, Schiavello R, Luciani G, Possati G. Different profiles of patients who require dialysis after cardiac surgery. Ann Thorac Surg. 2005 Mar;79(3):825-9; author reply 829-30. doi: 10.1016/j.athoracsur.2004.08.019.
- Kincaid EH, Ashburn DA, Hoyle JR, Reichert MG, Hammon JW, Kon ND. Does the combination of aprotinin and angiotensin-converting enzyme inhibitor cause renal failure after cardiac surgery? Ann Thorac Surg. 2005 Oct;80(4):1388-93; discussion 1393. doi: 10.1016/j.athoracsur.2005.03.136.
- Regner KR, Connolly HM, Schaff HV, Albright RC. Acute renal failure after cardiac surgery for carcinoid heart disease: incidence, risk factors, and prognosis. Am J Kidney Dis. 2005 May;45(5):826-32. doi: 10.1053/j.ajkd.2005.02.009.
- Mehta RH, Bruckman D, Das S, Tsai T, Russman P, Karavite D, Monaghan H, Sonnad S, Shea MJ, Eagle KA, Deeb GM. Implications of increased left ventricular mass index on in-hospital outcomes in patients undergoing aortic valve surgery. J Thorac Cardiovasc Surg. 2001 Nov;122(5):919-28. doi: 10.1067/mtc.2001.116558.
- Fischer UM, Weissenberger WK, Warters RD, Geissler HJ, Allen SJ, Mehlhorn U. Impact of cardiopulmonary bypass management on postcardiac surgery renal function. Perfusion. 2002 Nov;17(6):401-6. doi: 10.1191/0267659102pf610oa.
- Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21. doi: 10.1213/ane.0b013e31818240db.
- Brown JR, Cochran RP, Leavitt BJ, Dacey LJ, Ross CS, MacKenzie TA, Kunzelman KS, Kramer RS, Hernandez F Jr, Helm RE, Westbrook BM, Dunton RF, Malenka DJ, O'Connor GT; Northern New England Cardiovascular Disease Study Group. Multivariable prediction of renal insufficiency developing after cardiac surgery. Circulation. 2007 Sep 11;116(11 Suppl):I139-43. doi: 10.1161/CIRCULATIONAHA.106.677070.
- Arora P, Rajagopalam S, Ranjan R, Kolli H, Singh M, Venuto R, Lohr J. Preoperative use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers is associated with increased risk for acute kidney injury after cardiovascular surgery. Clin J Am Soc Nephrol. 2008 Sep;3(5):1266-73. doi: 10.2215/CJN.05271107. Epub 2008 Jul 30.
- Maslow AD, Chaudrey A, Bert A, Schwartz C, Singh A. Perioperative renal outcome in cardiac surgical patients with preoperative renal dysfunction: aprotinin versus epsilon aminocaproic acid. J Cardiothorac Vasc Anesth. 2008 Feb;22(1):6-15. doi: 10.1053/j.jvca.2007.07.017. Epub 2007 Nov 7.
- Salis S, Mazzanti VV, Merli G, Salvi L, Tedesco CC, Veglia F, Sisillo E. Cardiopulmonary bypass duration is an independent predictor of morbidity and mortality after cardiac surgery. J Cardiothorac Vasc Anesth. 2008 Dec;22(6):814-22. doi: 10.1053/j.jvca.2008.08.004. Epub 2008 Oct 22.
- Weir MR, Aronson S, Avery EG, Pollack CV Jr. Acute kidney injury following cardiac surgery: role of perioperative blood pressure control. Am J Nephrol. 2011;33(5):438-52. doi: 10.1159/000327601. Epub 2011 Apr 21.
- Swaminathan M, Shaw AD, Phillips-Bute BG, McGugan-Clark PL, Archer LE, Talbert S, Milano CA, Patel UD, Stafford-Smith M. Trends in acute renal failure associated with coronary artery bypass graft surgery in the United States. Crit Care Med. 2007 Oct;35(10):2286-91. doi: 10.1097/01.ccm.0000282079.05994.57.
- Bove T, Calabro MG, Landoni G, Aletti G, Marino G, Crescenzi G, Rosica C, Zangrillo A. The incidence and risk of acute renal failure after cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Aug;18(4):442-5. doi: 10.1053/j.jvca.2004.05.021.
- Chertow GM, Lazarus JM, Paganini EP, Allgren RL, Lafayette RA, Sayegh MH. Predictors of mortality and the provision of dialysis in patients with acute tubular necrosis. The Auriculin Anaritide Acute Renal Failure Study Group. J Am Soc Nephrol. 1998 Apr;9(4):692-8. doi: 10.1681/ASN.V94692.
- Leacche M, Rawn JD, Mihaljevic T, Lin J, Karavas AN, Paul S, Byrne JG. Outcomes in patients with normal serum creatinine and with artificial renal support for acute renal failure developing after coronary artery bypass grafting. Am J Cardiol. 2004 Feb 1;93(3):353-6. doi: 10.1016/j.amjcard.2003.10.020.
- Thakar CV, Worley S, Arrigain S, Yared JP, Paganini EP. Influence of renal dysfunction on mortality after cardiac surgery: modifying effect of preoperative renal function. Kidney Int. 2005 Mar;67(3):1112-9. doi: 10.1111/j.1523-1755.2005.00177.x.
- Doddakula K, Al-Sarraf N, Gately K, Hughes A, Tolan M, Young V, McGovern E. Predictors of acute renal failure requiring renal replacement therapy post cardiac surgery in patients with preoperatively normal renal function. Interact Cardiovasc Thorac Surg. 2007 Jun;6(3):314-8. doi: 10.1510/icvts.2006.148874. Epub 2007 Mar 7.
- McCullough PA, Haapio M, Mankad S, Zamperetti N, Massie B, Bellomo R, Berl T, Anker SD, Anand I, Aspromonte N, Bagshaw SM, Bobek I, Cruz DN, Daliento L, Davenport A, Hillege H, House AA, Katz N, Maisel A, Mebazaa A, Palazzuoli A, Ponikowski P, Ronco F, Shaw A, Sheinfeld G, Soni S, Vescovo G, Zanco P, Ronco C, Berl T; Acute Dialysis Quality Initiative (ADQI) Consensus Group. Prevention of cardio-renal syndromes: workgroup statements from the 7th ADQI Consensus Conference. Nephrol Dial Transplant. 2010 Jun;25(6):1777-84. doi: 10.1093/ndt/gfq180. Epub 2010 Apr 6. No abstract available.
- Chertow GM, Burdick E, Honour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005 Nov;16(11):3365-70. doi: 10.1681/ASN.2004090740. Epub 2005 Sep 21.
- Lassnigg A, Schmidlin D, Mouhieddine M, Bachmann LM, Druml W, Bauer P, Hiesmayr M. Minimal changes of serum creatinine predict prognosis in patients after cardiothoracic surgery: a prospective cohort study. J Am Soc Nephrol. 2004 Jun;15(6):1597-605. doi: 10.1097/01.asn.0000130340.93930.dd.
- Srisawat N, Hoste EE, Kellum JA. Modern classification of acute kidney injury. Blood Purif. 2010;29(3):300-7. doi: 10.1159/000280099. Epub 2010 Feb 3.
- Zavada J, Hoste E, Cartin-Ceba R, Calzavacca P, Gajic O, Clermont G, Bellomo R, Kellum JA; AKI6 investigators. A comparison of three methods to estimate baseline creatinine for RIFLE classification. Nephrol Dial Transplant. 2010 Dec;25(12):3911-8. doi: 10.1093/ndt/gfp766. Epub 2010 Jan 25.
- Bernardi MH, Schmidlin D, Schiferer A, Ristl R, Neugebauer T, Hiesmayr M, Druml W, Lassnigg A. Impact of preoperative serum creatinine on short- and long-term mortality after cardiac surgery: a cohort study. Br J Anaesth. 2015 Jan;114(1):53-62. doi: 10.1093/bja/aeu316. Epub 2014 Sep 19.
- Heymsfield SB, Arteaga C, McManus C, Smith J, Moffitt S. Measurement of muscle mass in humans: validity of the 24-hour urinary creatinine method. Am J Clin Nutr. 1983 Mar;37(3):478-94. doi: 10.1093/ajcn/37.3.478.
- Schutte JE, Longhurst JC, Gaffney FA, Bastian BC, Blomqvist CG. Total plasma creatinine: an accurate measure of total striated muscle mass. J Appl Physiol Respir Environ Exerc Physiol. 1981 Sep;51(3):762-6. doi: 10.1152/jappl.1981.51.3.762.
- Lee RC, Wang Z, Heo M, Ross R, Janssen I, Heymsfield SB. Total-body skeletal muscle mass: development and cross-validation of anthropometric prediction models. Am J Clin Nutr. 2000 Sep;72(3):796-803. doi: 10.1093/ajcn/72.3.796. Erratum In: Am J Clin Nutr 2001 May;73(5):995.
- von Herrath M, Holzer H. Oxidative inactivation of yeast fructose-1,6-bisphosphatase. Prog Clin Biol Res. 1985;180:329-40.
- Solntseva EI, Borisova OV. [Imidazole causes long-term elevation of evoked postsynaptic potential and potential-dependent calcium current in molluskan neurons]. Dokl Akad Nauk SSSR. 1988;300(3):760-3. No abstract available. Russian.
- Patel SS, Molnar MZ, Tayek JA, Ix JH, Noori N, Benner D, Heymsfield S, Kopple JD, Kovesdy CP, Kalantar-Zadeh K. Serum creatinine as a marker of muscle mass in chronic kidney disease: results of a cross-sectional study and review of literature. J Cachexia Sarcopenia Muscle. 2013 Mar;4(1):19-29. doi: 10.1007/s13539-012-0079-1. Epub 2012 Jul 10.
- Devarajan P. Update on mechanisms of ischemic acute kidney injury. J Am Soc Nephrol. 2006 Jun;17(6):1503-20. doi: 10.1681/ASN.2006010017. Epub 2006 May 17. No abstract available.
- Rodier F, Campisi J, Bhaumik D. Two faces of p53: aging and tumor suppression. Nucleic Acids Res. 2007;35(22):7475-84. doi: 10.1093/nar/gkm744. Epub 2007 Oct 16.
- Boonstra J, Post JA. Molecular events associated with reactive oxygen species and cell cycle progression in mammalian cells. Gene. 2004 Aug 4;337:1-13. doi: 10.1016/j.gene.2004.04.032.
- Meersch M, Schmidt C, Van Aken H, Martens S, Rossaint J, Singbartl K, Gorlich D, Kellum JA, Zarbock A. Urinary TIMP-2 and IGFBP7 as early biomarkers of acute kidney injury and renal recovery following cardiac surgery. PLoS One. 2014 Mar 27;9(3):e93460. doi: 10.1371/journal.pone.0093460. eCollection 2014.
- Truong LD, Shen SS. Immunohistochemical diagnosis of renal neoplasms. Arch Pathol Lab Med. 2011 Jan;135(1):92-109. doi: 10.5858/2010-0478-RAR.1.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.