Hemodynamic Effects of Low vs. High Dialysate Temperature or Bicarbonate Concentration in Chronic Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Blood pressure (BP)
研究概览
简要总结
To elucidate the role of dialysate temperature and bicarbonate on hemodynamic parameters, plasma pH and electrolytes that potentially mediate this effect, the investigators wish to conduct a single-blinded, randomized, controlled, crossover study, specifically examining the effects of
- A fixed low temperature dialysate of 35°C compared to a fixed dialysate temperature of 37°C.
- A low dialysate bicarbonate concentration of 30 mmol/L compared to a high dialysate bicarbonate concentration of 38 mmol/L.
详细描述
Background
Intradialytic hypotension (IDH) is a common complication of hemodialysis (HD) and is considered one of the most frequent complications with a prevalence between 10-12% depending on the definition of IDH (1). IDH has been associated with inefficient dialysis (2), vascular access thrombosis (3) and mortality (4,5).
Orthostatic hypotension (OH) is another common complication in HD with a prevalence around 42% in patients initiating HD treatment (6). OH is significantly associated with worse outcome in HD patients in terms of an increased two-year mortality (4) and increased risk of all-cause death (6).
Understanding the mechanisms underlying IDH and OH has the potential to optimize HD treatment, in order to minimize the occurrence of IDH and OH, potentially improving not only patient mortality and morbidity but also the everyday comfort of chronic HD patients when receiving dialysis treatment.
This study will investigate the hemodynamic effect of alterations in dialysate bicarbonate and dialysate temperature.
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
- Single (Participant)
盲法说明
Temperature or bicarbonate settings will not be revealed to participants during the study.
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
- •Regular dialysis (HD or HDF) therapy for >3 months
- •Age >18 years
- •Stable and functional arteriovenous (AV)-fistula
- •Able to achieve a dialysis blood flow > 250 mL
- •Able to stand up for a minimum of 10 min
- •Able to undergo a 4 hour dialysis session without eating, drinking or sleeping
- •Proven cabable of cumulative ultrafiltration of 2% of end-dialytic weight (EDW)
- •Able to give informed consent to participation in the study
- •Hematocrit >30%
- •BMI >18 and <35
排除标准
- •Central venous catheter for HD or HDF
- •Recirculation in AV-fistula
- •Acute myocardial infarction within 3 months
- •Atrial fibrillation
- •Active malignant or infectious diseases
- •Cerebrovascular incident within 3 months
- •Pregnancy
- •Alcohol or drug abuse
- •History of interruptions during HD or untimely termination of HD treatment
研究组 & 干预措施
Low temperature
Dialysate temperature
干预措施: Low dialysate temperature (Other)
High temperature
Dialysate temperature
干预措施: High dialysate temperature (Other)
Low bicarbonate
Dialysate bicarbonate concentration
干预措施: Low dialysate bicarbonate concentration (Other)
High bicarbonate
Dialysate bicarbonate concentration
干预措施: High dialysate bicarbonate concentration (Other)
结局指标
主要结局
Blood pressure (BP)
时间窗: 4 weeks
SBP (mmHg), Mean BP (mmHg) and Ortostatic BP (mmHg)
次要结局
- Intradialytic stroke volume(4 weeks)
- Intradialytic cardiac output(4 weeks)
- Intradialytic hypotension (IDH)(4 weeks)
- Intradialytic total peripheral resistance(4 weeks)
- Intradialytic heart rate(4 weeks)
- Plasma magnesium(4 weeks)
- Ortostatic hypotension (OH)(4 weeks)
- Intradialytic central blood volume(4 weeks)
- Intradialytic mean arterial blood pressure(4 weeks)
- Plasma calcium(4 weeks)
- Plasma potassium(4 weeks)