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不同血流速率对非抗凝连续性肾脏替代治疗中滤器及管路寿命的影响:一项三臂、单盲随机对照试验方案(血流-连续性肾脏替代治疗研究)

Effects of different blood flow rates on filter and circuit life in non-anticoagulation CRRT: Protocol for a three-arm, single-blind randomized controlled trial (the Flow-CRRT Study).

作者信息

Liu Caihong, Bu Qiongxing, Wang Fang, Wei Wei, Huang Yongxiu, Ren Jinglei, Koyner Jay L, Zhang Ling, Zhao Yuliang

机构信息

Department of Nephrology, Institute of Kidney Diseases, West China Hospital, Sichuan University, Chengdu, China.

Department of Nephrology, West China Hospital of Sichuan University/West China School of Nursing, Sichuan University, Chengdu, China.

出版信息

PLoS One. 2025 Aug 22;20(8):e0330845. doi: 10.1371/journal.pone.0330845. eCollection 2025.

DOI:10.1371/journal.pone.0330845
PMID:40845006
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12373228/
Abstract

BACKGROUND

Non-anticoagulation is a commonly used strategy in continuous renal replacement therapy (CRRT) among patients with high-bleeding risk. However, the optimal blood flow rate (BFR) to maximize filter and circuit life remains uncertain. This study is designed to elucidate the impact of different BFRs on the durability of filters and circuits in CRRT without anticoagulation.

METHODS

This single-center, prospective, three-arm, single-blind, randomized controlled trial (RCT) will involve adult patients requiring non-anticoagulation continuous veno-venous hemodiafiltration (CVVHDF). A total of 486 filters and circuits will be enrolled and randomly assigned to one of three BFR groups: low (150 mL/min), medium (200 mL/min), or high (250 mL/min) BFR group. The outcomes will be analyzed by both intention-to-treat analysis and per-protocol analysis. The primary outcome is filter and circuit life, which is defined as the time from CRRT initiation to CRRT termination due to extracorporeal circuit clotting or other reasons, alongside the proportion of patent circuits at 24, 48, and 72 hours. Secondary outcomes encompass clinical outcomes and potential adverse events such as bleeding and hemodynamic alterations.

DISCUSSION

This study is aiming at comparing the filter and circuit life under different BFR levels during CVVHDF without anti-coagulation. The results may add knowledge to the optimal BFR to prevent extracorporeal circulation clotting and prolong filter and circuit life in non-anticoagulation CRRT.

TRIAL REGISTRATION

The study has been registered at https://www.chictr.org.cn (ChiCTR2400087819).

摘要

背景

对于出血风险高的患者,非抗凝是连续性肾脏替代治疗(CRRT)中常用的策略。然而,使滤器和体外循环寿命最大化的最佳血流量(BFR)仍不确定。本研究旨在阐明不同BFR对无抗凝CRRT中滤器和体外循环耐久性的影响。

方法

这项单中心、前瞻性、三臂、单盲、随机对照试验(RCT)将纳入需要非抗凝连续性静脉-静脉血液透析滤过(CVVHDF)的成年患者。总共486个滤器和体外循环将被纳入并随机分配到三个BFR组之一:低(150 mL/分钟)、中(200 mL/分钟)或高(250 mL/分钟)BFR组。结果将通过意向性分析和符合方案分析进行分析。主要结局是滤器和体外循环寿命,定义为从CRRT开始到因体外循环凝血或其他原因终止CRRT的时间,以及24、48和72小时时通畅体外循环的比例。次要结局包括临床结局和潜在不良事件,如出血和血流动力学改变。

讨论

本研究旨在比较无抗凝CVVHDF期间不同BFR水平下的滤器和体外循环寿命。结果可能会增加关于最佳BFR的知识,以预防体外循环凝血并延长无抗凝CRRT中滤器和体外循环的寿命。

试验注册

该研究已在https://www.chictr.org.cn注册(ChiCTR2400087819)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ef/12373228/78c70aee8166/pone.0330845.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ef/12373228/78c70aee8166/pone.0330845.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81ef/12373228/78c70aee8166/pone.0330845.g001.jpg

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本文引用的文献

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Front Med (Lausanne). 2024 Aug 21;11:1442065. doi: 10.3389/fmed.2024.1442065. eCollection 2024.
2
Customized Citrate Anticoagulation versus No Anticoagulant in Continuous Venovenous Hemofiltration in Critically Ill Patients with Acute Kidney Injury: A Prospective Randomized Controlled Trial.定制枸橼酸抗凝与急性肾损伤危重症患者连续性静脉-静脉血液滤过中无抗凝的前瞻性随机对照试验。
Blood Purif. 2023;52(5):455-463. doi: 10.1159/000529076. Epub 2023 Mar 1.
3
How to Prolong Filter Life During Continuous Renal Replacement Therapy?
如何在持续肾脏替代治疗期间延长滤器使用寿命?
Crit Care. 2022 Mar 22;26(1):62. doi: 10.1186/s13054-022-03910-8.
4
Development and External Validation of a Model for Predicting Sufficient Filter Lifespan in Anticoagulation-Free Continuous Renal Replacement Therapy Patients.开发和外部验证一种预测无抗凝连续性肾脏替代治疗患者足够滤器寿命的模型。
Blood Purif. 2022;51(8):668-678. doi: 10.1159/000519409. Epub 2021 Oct 21.
5
Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy.非药物干预措施预防连续性肾脏替代治疗中体外循环凝血。
Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
6
Low Blood Flow Continuous Veno-Venous Haemodialysis Compared with Higher Blood Flow Continuous Veno-Venous Haemodiafiltration: Effect on Alarm Rates, Filter Life, and Azotaemic Control.低血流连续静脉-静脉血液透析与高血流连续静脉-静脉血液透析滤过的比较:对报警率、滤器寿命和氮质血症控制的影响。
Blood Purif. 2022;51(2):130-137. doi: 10.1159/000516146. Epub 2021 May 19.
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