Assessment of Subjective and Hemodynamic Tolerance of Different High- and Low-flux Dialysis Membranes in Patients Undergoing Chronic Intermittent Hemodialysis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- comparative evaluation of mean hemodynamic parameters (i.e. systolic and diastolic blood pressure, peripheral resistance and cardiac output) during dialysis
研究概览
简要总结
Background:
High- and low-flux dialysis membranes made of different materials may correlate with various hemodynamic tolerance profiles. This study aims to investigate hemodynamic response and incidence of hypotensive episodes by comparing some of the most commonly used high- and low-flux dialyzers.
Methodology:
The study was designed as an open label, randomized, cross-over investigation, including 25 patients undergoing chronic hemodialysis. Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other. The hemodynamic profile was assessed with a non-invasive technique and patients were asked to provide tolerance feedback through a questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 and older
- •ability to understand the information presented and sign the informed consent
- •chronic hemodialysis for at least 8 weeks
- •stable dialysis prescriptions and modality in the 2 weeks prior to protocol implementation
排除标准
- •mental illness;
- •inability to understand the information presented and sign the informed consent;
- •acute disease requiring hospitalization at the time of patient enrolment
- •pregnancy and breast feeding
研究组 & 干预措施
Revaclear
干预措施: Revaclear (Device)
Helixone high flux
干预措施: Helixone high flux (Device)
Xevonta
干预措施: Xevonta (Device)
Helixone low flux
干预措施: Helixone low flux (Device)
结局指标
主要结局
comparative evaluation of mean hemodynamic parameters (i.e. systolic and diastolic blood pressure, peripheral resistance and cardiac output) during dialysis
时间窗: 4 weeks
comparative evaluation of subjective tolerance across the various membranes
时间窗: 4 weeks
As to the assessment of subjective tolerance, we decided to administer the questionnaire designed by Cruz et al. \[Cruz DN, Mahnensmith RL, Brickel HM, Perazella MA. Midodrine and cool dialysate are effective therapies for symptomatic intradialytic hypotension. Am. J. Kidney Dis. 1999 Mag;33(5):920-926\] then modified by Teruel et al. \[Teruel JL, Martins J, Merino JL, Fernández Lucas M, Rivera M, Marcén R, et al. Temperature of the dialysis bath and hemodialysis tolerance. Nefrología: PublicaciónOficial De La Sociedad Española Nefrologia. 2006;26(4):461-468\] and to integrate it with a 1 to 10 numerical scale to assess patient well-being
comparative evaluation of Kt/V and of beta-2 microglobulin removal
时间窗: 4 weeks
次要结局
- comparative analysis of the incidence of symptomatic and non-symptomatic systolic pressure drops (> 20 mmHg)(4 weeks)
研究者
Luca Gabutti, MD
Prof, Head of Department of Internal Medicine
Ospedale Regionale di Locarno