Randomized Controlled Crossover Trial to Evaluate the Efficacy of Rinsing Techniques for Removal of Disinfectant in Hemodialyzer

Chinakorn Sujimongkol, Suntharee Wichakhreuang, Pattaraporn Wongput, S. Daochai
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Abstract

BACKGROUND: Peroxyacetic acid solution (PAA) has come into widespread use as a dialyzer germicide after the hemodialyzer reprocessing and reusing has been frequently practiced in many settings globally. A recirculation technique which is an existing rinsing preferred by users to obliterate residual chemical for the pre-dialysis process. However, there is uncertainty whether with and without recirculation is most effective due to a paucity of high-quality data. OBJECTIVE: To assess the rinsing techniques whether remaining chemical has been gotten rid of properly from the hemodialyzer among different manners. METHODS: A crossover design was used to determine whether the non-recirculation technique is equivalent to the recirculating technique for efficient clearance of the chemical debris in a dialyzer. Reused dialyzers were the randomized objects for the experiment, retrieved from enrolled patients who were treated with hemodialysis. The orderings of the rinsing procedure were randomised into two arms (recirculating versus non-recirculating techniques). The main measures of technique performance were peracetic residuals. RESULTS: A total of 24 reused hemodialyzers were recruited from chronic hemodialysis patients and randomised, 12 to each arm in which without carryover effect were aliased in each other. Nevertheless, using a non-recirculating method decreased the odds of having germicide (PAA) residues by roughly 7% (p > 0.10). The results from both equivalence tests were statistically equivalent. A peak level of PAA was detected in the time-series at 10 minute with given a beta coefficient of 1.15 (95% CI [0.22-2.09]). These values indicated rebound effects. CONCLUSION: The capacity to elimination of PAA residuals of the non-recirculating technique was as effective as that of the recirculation technique despite rebound effects.
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评价冲洗技术去除血液透析器消毒剂效果的随机对照交叉试验
背景:过氧乙酸溶液(PAA)作为血液透析器杀菌剂已被广泛使用,因为血液透析器的再加工和再利用已在全球许多环境中频繁实施。一种循环技术,是一种现有的冲洗技术,用户首选它来消除透析前过程中残留的化学物质。然而,由于缺乏高质量的数据,不确定有无再循环是否最有效。目的:评价不同冲洗方式对血液透析器中残留化学物质的去除效果。方法:采用交叉设计来确定非再循环技术是否等同于再循环技术,以有效清除透析器中的化学碎片。重复使用的透析器是实验的随机对象,从接受血液透析治疗的入组患者中检索。冲洗程序的顺序随机分为两组(再循环与非再循环技术)。技术性能的主要指标是过氧乙酸残留量。结果:共从慢性血液透析患者中招募了24台重复使用的血液透析器并随机分组,每组12台,相互间无结转效应。然而,使用非循环方法可使杀菌剂(PAA)残留的几率降低约7% (p > 0.10)。两种等效性试验的结果在统计上是相等的。在10分钟的时间序列中检测到PAA的峰值水平,给定的β系数为1.15 (95% CI[0.22-2.09])。这些值表明反弹效应。结论:尽管存在回弹效应,但非循环技术对PAA残留的清除能力与循环技术相当。
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