Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Change in Intra-dialytic Decline in Systolic Blood Pressure
研究概览
简要总结
Intra-dialytic hypotensive (IDH) events can be defined as an abrupt decline in blood pressure that cause symptoms and/or require an intervention. They are common, affecting up to one third of maintenance HD sessions. Detrimental associations include: development of myocardial stunning, cerebral hypo-perfusion, vascular access thrombosis and greater mortality.
Rapid solute removal by HD generates temporary osmotic gradients between the intra-vascular and intra-cellular compartments, promoting trans-cellular fluid movement and resultant hypotension. Manipulation of osmotic gradients, e.g. using higher dialysate sodium (DNa), may ameliorate excess SBP decline during HD.
This study aims to assess the effects of higher (142 mmol/L) versus lower (138 mmol/L) dialysate sodium (DNa) use in adult chronic hemodialysis patients admitted to hospital on intra-dialytic blood pressure and biomarkers of cardiac ischemia.
The investigators will randomly assign subjects to higher versus lower DNa during their hospital stay, up to a maximum of six HD sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Chronic HD (>90 days)
- •Informed consent
- •First admission during study period.
排除标准
- •Use of pressors
- •Pre-dialysis serum sodium <=128mmol/L or > 145 mmol/L
- •Pre-dialysis SBP >180 mmHg
- •Intensive care stay earlier in admission
- •Expected length of stay <24 hours (e.g. admission for HD access procedure)
- •Acute coronary syndrome within seven days
- •Acute stroke
- •Institutionalized individuals
- •Pregnancy
研究组 & 干预措施
Lower dialysate sodium
Dialysate sodium concentration of 138 mmol/L
干预措施: Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate) (Drug)
Higher dialysate sodium
Dialysate sodium concentration of 142 mmol/L
干预措施: Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate) (Drug)
结局指标
主要结局
Change in Intra-dialytic Decline in Systolic Blood Pressure
时间窗: Average decline in systolic blood pressure will be measured up to a maximum of six inpatient HD sessions, occurring over a two-week time period
Pre-dialysis SBP minus lowest intra-dialytic SBP. The data table reflect the change in systolic blood pressured (SBP) assessed at up to 6 HD sessions, where the change for each session was calculated as the pre-SBP minus the lowest SBP (during the session), and the change values from the multiple sessions were then averaged for a participant.
次要结局
- Change in Pre-dialysis High-sensitivity Troponin I(The change in pre-dialysis high sensitivity troponin I concentrations will be measured between the first and second inpatient hemodialysis sessions, occuring over a period of three days)
研究者
Finnian McCausland
Assistant Professor of Medicine, Harvard Medical School
Brigham and Women's Hospital