CVVH、CVVHDF 和 SLED 的简化区域柠檬酸盐抗凝方案：一项试点研究
2019年7月23日 更新者：Enrico Fiaccadori、University of Parma
针对 CVVH、CVVHDF 和 SLED 的简化区域柠檬酸盐抗凝方案侧重于预防 RRT 相关的低磷血症和优化酸碱平衡：一项试点研究
该研究的目的是：1) 评估重症患者 [CVVH、CVVHDF 和 SLED（持续低效透析）] 的不同肾脏替代疗法 (RRT) 期间酸碱变化的发生率和低磷血症的发生率] 通过使用简化的局部柠檬酸盐抗凝（RCA）方案，结合采用含磷酸盐的溶液作为透析液和/或置换液； 2) 优化所采用的不同溶液（包括柠檬酸盐）的输注速率，以获得适当的电解质和缓冲液供应。
这种方法的最终目标是减少频繁监测酸碱状态和电解质（特别是离子钙水平）的需要，并避免频繁调整 RCA-RRT 参数（不同剂量的输注速度）的需要。溶液、RRT 过程中的电解质补充）。
这种方法可以简化柠檬酸盐的抗凝方案，以尽量减少阻碍 RCA 在日常实践中更广泛扩散的潜在担忧。
研究概览
详细说明
持续抗凝的需要代表了 RRT 方式的一个潜在缺点。
KDIGO 2012 年急性肾损伤 (AKI) 指南建议采用 RCA 作为无柠檬酸盐禁忌症患者连续 RRT (CRRT) 的首选抗凝方式。
柠檬酸盐也被引入作为 SLED 的抗凝剂，并且它在主要扩散性延长间歇模式的背景下的使用已被证明是一种简单而安全的方法，可以在使用浓缩柠檬酸盐溶液（例如 ACD-A）时维持体外循环。
低磷酸盐血症是 RRT 的一个已知问题，据报道，在使用标准 RRT 溶液时，高达 50-80% 的病例会出现低磷血症，尤其是在持续/延长间歇模式下，当给予高 RRT 剂量时。
由于在这种临床情况下会出现相关的低磷血症相关并发症，因此在危重患者中应避免 RRT 相关的磷酸盐耗竭。
采用含磷酸盐的 CRRT 溶液可以降低低磷血症的发生率，并最大限度地减少肠外磷补充的需要。在 RCA-RRT 的情况下，采用市售的含磷酸盐 CRRT 溶液可以实现双重目标最大限度地减少 RRT 引起的低磷血症并确保足够的电路寿命，同时避免电解质和酸碱紊乱。
研究类型
观察性的
注册 (预期的)
30
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Parma、意大利
- University of Parma - UO Nefrologia AOU
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
年龄 >=18 岁的严重急性肾损伤 (AKI) 或终末期肾病 (ESRD) 需要肾脏替代治疗的危重患者
描述
纳入标准：
- 年龄 >= 18 岁
- 严重急性肾损伤 (AKI) 需要连续或长期间歇性肾脏替代治疗的危重患者
- 终末期肾病 (ESRD) 需要持续或长期间歇性肾脏替代治疗的危重患者
排除标准：
- 年龄 < 18 岁
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：其他
- 时间观点：预期
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 |
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低磷血症
大体时间：72小时
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在连续肾脏替代治疗 (CRRT) 或持续低效透析 (SLED) 的前 72 小时内发生低磷血症
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72小时
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酸碱紊乱
大体时间：72小时
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使用简化的 RCA 协议在 CRRT 和 SLED 期间发生酸碱紊乱
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72小时
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RCA-RRT参数的变化
大体时间：72小时
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评估从初始 RRT 设置改变 RCA-RRT 透析参数的必要性
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72小时
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RCA-RRT解决方案的变体
大体时间：72小时
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评估从初始 RRT 设置改变 RRT 溶液流速的必要性
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72小时
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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低镁血症
大体时间：72小时
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在 CRRT 或 SLED 的前 72 小时内发生低镁血症
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72小时
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RCA的功效
大体时间：72小时
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RCA 在电路寿命和过滤效率方面的功效
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72小时
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Morabito S, Pistolesi V, Cibelli L, Pierucci A. [Continuous renal replacement therapies (CRRT) will remain the most widely adopted dialysis modality in the critically ill]. G Ital Nefrol. 2009 Jan-Feb;26(1):13-21. Italian.
- Brophy PD, Somers MJ, Baum MA, Symons JM, McAfee N, Fortenberry JD, Rogers K, Barnett J, Blowey D, Baker C, Bunchman TE, Goldstein SL. Multi-centre evaluation of anticoagulation in patients receiving continuous renal replacement therapy (CRRT). Nephrol Dial Transplant. 2005 Jul;20(7):1416-21. doi: 10.1093/ndt/gfh817. Epub 2005 Apr 26.
- Oudemans-van Straaten HM, Wester JPJ, de Pont ACJM, Schetz MRC. Anticoagulation strategies in continuous renal replacement therapy: can the choice be evidence based? Intensive Care Med. 2006 Feb;32(2):188-202. doi: 10.1007/s00134-005-0044-y. Epub 2006 Feb 2.
- Tolwani AJ, Wille KM. Anticoagulation for continuous renal replacement therapy. Semin Dial. 2009 Mar-Apr;22(2):141-5. doi: 10.1111/j.1525-139X.2008.00545.x.
- Mariano F. [Citrate: a different mental approach to extracorporeal circuit anticoagulation]. G Ital Nefrol. 2012 Jan-Feb;29(1):27-32. Italian.
- Mariano F, Triolo G. [Anticoagulation of extracorporeal circuit in critically ill patients]. G Ital Nefrol. 2007 Jan-Feb;24(1):34-42. Italian.
- Oudemans-van Straaten HM. Citrate anticoagulation for continuous renal replacement therapy in the critically ill. Blood Purif. 2010;29(2):191-6. doi: 10.1159/000245646. Epub 2010 Jan 8.
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- Mariano F, Tedeschi L, Morselli M, Stella M, Triolo G. Normal citratemia and metabolic tolerance of citrate anticoagulation for hemodiafiltration in severe septic shock burn patients. Intensive Care Med. 2010 Oct;36(10):1735-1743. doi: 10.1007/s00134-010-1909-2. Epub 2010 May 18.
- Chadha V, Garg U, Warady BA, Alon US. Citrate clearance in children receiving continuous venovenous renal replacement therapy. Pediatr Nephrol. 2002 Oct;17(10):819-24. doi: 10.1007/s00467-002-0963-6. Epub 2002 Sep 7.
- Mariano F, Tetta C, Stella M, Biolino P, Miletto A, Triolo G. Regional citrate anticoagulation in critically ill patients treated with plasma filtration and adsorption. Blood Purif. 2004;22(3):313-9. doi: 10.1159/000078788.
- Hetzel GR, Taskaya G, Sucker C, Hennersdorf M, Grabensee B, Schmitz M. Citrate plasma levels in patients under regional anticoagulation in continuous venovenous hemofiltration. Am J Kidney Dis. 2006 Nov;48(5):806-11. doi: 10.1053/j.ajkd.2006.07.016.
- Mariano F, Morselli M, Bergamo D, Hollo Z, Scella S, Maio M, Tetta C, Dellavalle A, Stella M, Triolo G. Blood and ultrafiltrate dosage of citrate as a useful and routine tool during continuous venovenous haemodiafiltration in septic shock patients. Nephrol Dial Transplant. 2011 Dec;26(12):3882-8. doi: 10.1093/ndt/gfr106. Epub 2011 Mar 8.
- Bakker AJ, Boerma EC, Keidel H, Kingma P, van der Voort PH. Detection of citrate overdose in critically ill patients on citrate-anticoagulated venovenous haemofiltration: use of ionised and total/ionised calcium. Clin Chem Lab Med. 2006;44(8):962-6. doi: 10.1515/CCLM.2006.164.
- Fukuda T, Toyoshima S, Nakashima Y, Koshitani O, Kawaguchi Y, Momii A. Tolerable infusion rate of citrate based on clinical signs and the electrocardiogram in conscious dogs. Clin Nutr. 2006 Dec;25(6):984-93. doi: 10.1016/j.clnu.2006.01.011. Epub 2006 May 15.
- Forsythe RM, Wessel CB, Billiar TR, Angus DC, Rosengart MR. Parenteral calcium for intensive care unit patients. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006163. doi: 10.1002/14651858.CD006163.pub2.
- Pozzato M. [Citrate: an additional resource for anticoagulation in continuous replacement therapy]. G Ital Nefrol. 2012 Jan-Feb;29(1):20-6. Italian.
- Bai M, Zhou M, He L, Ma F, Li Y, Yu Y, Wang P, Li L, Jing R, Zhao L, Sun S. Citrate versus heparin anticoagulation for continuous renal replacement therapy: an updated meta-analysis of RCTs. Intensive Care Med. 2015 Dec;41(12):2098-110. doi: 10.1007/s00134-015-4099-0.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年6月1日
初级完成 (实际的)
2019年6月1日
研究完成 (预期的)
2021年1月31日
研究注册日期
首次提交
2019年5月29日
首先提交符合 QC 标准的
2019年6月3日
首次发布 (实际的)
2019年6月6日
研究记录更新
最后更新发布 (实际的)
2019年7月24日
上次提交的符合 QC 标准的更新
2019年7月23日
最后验证
2019年6月1日
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.