Integrated Strategies to Prevent Intradialytic Hypotension: a Prospective Randomized Cross-over Trial in Hypotension-prone Hemodialysis Patients (The DialHypot Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Occurrence of intradialytic hypotensive episodes (number of episodes within every HD session and time interval from HD start)
研究概览
简要总结
The present study is aimed at comparing different strategies of UF profiling, dialysate sodium individualization and sodium profiling (even combining one with the other) and at evaluating the effectiveness of a new UF profile which has an ascending/descending shape. The goal of the study is to provide better dialysis tolerance and lower rates of intradialytic hypotensive events by the application of this UF profile design in combination with a neutral sodium balance.
详细描述
This is a prospective, randomized, crossover trial. The study will be performed in 2 phases. Each phase will be divided in several sub-phases (see "4.1 Study phases"). Phase 1 will consist of 9 weeks of treatment (27 HD sessions) for each patient; phase 2 will consist of 11 weeks of treatment (33 HD sessions) for each patient. Each subject will be used as his/her own control. Dry weight, anti-hypertensive medications and dialysis parameters will not be modified during the study phases, except for UF rate and dialysate sodium concentration.
Study phases
1 - First phase: validation of the new UF profile with a standard dialysate sodium concentration
- run-in: constant Na concentration, constant UF rate - 2 weeks (6 sessions)
- 2-step descending Na profile, linear descending UF profile - 3 weeks (9 sessions)
- washout: constant Na concentration, constant UF rate - 1 week (3 sessions)
- 2-step descending Na profile, ascending/descending UF profile - 3 weeks (9 sessions)
2 - Second phase: combination of UF profiles and individualized dialysate sodium concentration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •age ≥ 18 years
- •thrice weekly HD regimen for more than 6 months
- •"hypotension-prone patients": ≥ 3 episodes of IDH in the month preceding the run-in phase of the study
排除标准
- •IDWG < 1.4% of dry weight (corresponding to < 1 kg in a 70-kg person)
- •twice weekly HD regimen
- •residual daily urine output > 300 mL
- •active acute disease or hospitalization in the 8 weeks preceding the run-in phase
研究组 & 干预措施
Linear descending UF profile
2-step descending Na profile, linear descending UF profile 3 weeks (9 sessions)
干预措施: UF and Na profiling (Other)
Run-in & washout phases
constant Na concentration, constant UF rate 3 weeks (6+3 sessions)
干预措施: UF and Na profiling (Other)
Ascending/descending UF profile
2-step descending Na profile, ascending/descending UF profile 3 weeks (9 sessions)
干预措施: UF and Na profiling (Other)
结局指标
主要结局
Occurrence of intradialytic hypotensive episodes (number of episodes within every HD session and time interval from HD start)
时间窗: Within each dialysis session from the time of enrolment to the end of each study phase (9-11 weeks)
Hypotensive events and symptoms (headache, cramps, nausea and vomiting) will be recorded and analyzed as both number of occurrences and time of occurrence from the beginning of the HD session. IDH will be defined as follows: * "symptomatic IDH": decrease in SBP ≥ 20 mmHg or in MAP ≥ 10 mmHg associated with symptoms (KDIGO definition) * "asymptomatic IDH": drop in BP (SBP ≥ 20 mmHg or MAP ≥ 10 mmHg) within a 20 minutes interval, regardless of symptoms * for patients whose SBP is \< 100 mmHg at the beginning of treatment, the investigators will consider as IDH any decrease of SBP ≥ 10%
次要结局
- Achievement of UF(Within each dialysis session from the time of enrolment to the end of each study phase (9-11 weeks))
- Dialysis dose(Within each dialysis session from the time of enrolment to the end of each study phase (9-11 weeks))
研究者
Enrico Fiaccadori
University Professor
University of Parma