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一种简化的个体化局部枸橼酸抗凝血液透析方案:一项单中心、随机临床研究。

A simplified protocol for individualized regional citrate anticoagulation for hemodialysis: A single-center, randomized clinical study.

机构信息

Department of Nephrology, The First Affiliated Hospital of Nanchang University, Jiangxi, Nanchang, China.

出版信息

Medicine (Baltimore). 2021 Feb 26;100(8):e24639. doi: 10.1097/MD.0000000000024639.

Abstract

INTRODUCTION

The lack of individualized treatment protocols and complicated procedures are important factors limiting the use of regional citrate anticoagulation (RCA) technology in hemodialysis. This study aims to validate the safety and efficacy of a simplified individualized RCA protocol for hemodialysis.

MATERIALS AND METHODS

From June 2019 to August 2019, 45 patients with active bleeding or bleeding tendency undergoing maintenance hemodialysis in the Nephrology Department of the First Affiliated Hospital of Nanchang University were randomly divided into a modified conventional RCA protocol group with a low-flux dialyzer, a simplified individualized RCA protocol group with a high-flux dialyzer, and a simplified individualized RCA protocol group with a low-flux dialyzer.

RESULTS

A total of 45 patients were included in this study. The mean age of the patients was 57.38 ± 19.05 years, and 78% were men. Forty-three patients completed 4 hours of hemodialysis, and the median total clotting scores in the 3 groups were 11, 12, and 12. Compared with the modified conventional RCA protocol group with a low-flux dialyzer, the 2 simplified individualized RCA protocol groups had better clotting scores for the dialyzer, arterial bubble trap, and single-pool urea clearance index (spKt/VBUN) and lower costs. Moreover, these parameters did not differ between the 2 simplified individualized RCA protocol groups. No electrolyte or acid-base imbalances or citrate poisoning was observed in any of the 3 groups. Adverse events did not differ significantly among the 3 groups.

CONCLUSIONS

The simplified individualized RCA protocol is safe, effective, and easy to implement. Therefore, this protocol can be promoted for clinical practice.

TRIAL REGISTRATION

This study was registered in the Chinese Clinical Study Registry under registration number ChiCTR1900023801.

摘要

简介

缺乏个体化的治疗方案和复杂的程序是限制局部枸橼酸钠抗凝(RCA)技术在血液透析中应用的重要因素。本研究旨在验证一种简化的个体化 RCA 方案用于血液透析的安全性和有效性。

材料与方法

2019 年 6 月至 2019 年 8 月,南昌大学第一附属医院肾内科收治的 45 例活动性出血或出血倾向的维持性血液透析患者,随机分为改良常规 RCA 方案(低通量透析器)组、简化个体化 RCA 方案(高通量透析器)组和简化个体化 RCA 方案(低通量透析器)组。

结果

共纳入 45 例患者,年龄 57.38±19.05 岁,男性 78%。43 例患者完成 4 小时血液透析,3 组患者总凝血评分中位数分别为 11、12、12。与改良常规 RCA 方案(低通量透析器)组相比,2 种简化个体化 RCA 方案组透析器、动脉气泡捕集器及单室尿素清除指数(spKt/VBUN)的凝血评分更好,费用更低,且 2 种简化个体化 RCA 方案组间差异无统计学意义。3 组患者均未出现电解质和酸碱平衡紊乱或枸橼酸中毒。3 组患者的不良事件发生率差异无统计学意义。

结论

简化的个体化 RCA 方案安全、有效且易于实施。因此,该方案可推广应用于临床实践。

试验注册

本研究在中国临床试验注册中心注册,注册号 ChiCTR1900023801。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/656f/7909225/ef0d23364546/medi-100-e24639-g001.jpg

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