Dialysate Sodium Lowering Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Frequency of Intradialytic Hypotension
研究概览
简要总结
This is a pilot randomized clinical trial in which patients treated with 3X per weekly conventional hemodialysis will be treated to a dialysate sodium 135 mEq/L vs. 138 mEq/L and followed for safety and tolerability, effects on BP and volume.
详细描述
This is a pilot randomized clinical trial in which hypertensive hemodialysis patients will be randomized to a low dialysate sodium (Na) of 135 mEq/L or a standard dialysate Na of 138 mEq/L. Patients will be randomized 2:1 to the low arm. Dialysate Na will be lowered 1 mEq/L every 2 weeks, as tolerated. Tolerance will be assessed by symptoms, intradialytic hypotension (IDH) episodes (systolic BP <90 or intervention for symptoms or BP drop during dialysis), achievement of dry weight. The trial will last for 6 to 12 months, for an individual, depending on when they entered the trial. The primary outcome is feasibility and safety of using the lower dialysate sodium which is assessed by symptoms during or immediately after dialysis, intradialytic hypotension episodes and the frequency of emergency room visits and hospitalizations. Several secondary outcomes will be measured including blood pressure prior to dialysis and at home, change in plasma Na over time, dry weight, post-dialysis weight, interdialytic weight change, symptoms of thirst and dry mouth, self-reported dialysis recovery time, relative blood volume change during a single treatment (via 'Critline') and, in patients without an implanted electronic device, extraceullular fluid volume (via bioimpedance).
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
- Single (Participant)
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
- •Age >18 years
- •Patients undergoing thrice weekly in-center conventional HD
- •At least 90 days since start of hemodialysis
- •Absence of pulmonary edema / signs of fluid overload on physical exam
- •Currently dialyzing at a DNa >=137 mEq/L
- •Single session Kt/V >=1.3 each month for the past 2 months
- •Hypertensive, defined by a pre-dialysis BP of >140/90 or treatment with 1 or more antihypertensive agents
- •No more than 1 skipped treatment and no more than 1 session per month shortened by >10 min
- •Life expectancy >12 months
- •Able to provide Informed Consent
- •Speaks and understands English
排除标准
- •Prone to IDH, defined as IDH occurring in >10% of treatments in the past 3 months. IDH will be defined as symptoms (e.g. cramps, dizziness, loss of consciousness) and/or intra- or post-dialytic systolic BP <90 mm Hg and/or use of intervention(s) (UF goal lowered, treatment stopped early, or saline given) because of IDH
- •Pregnancy
结局指标
主要结局
Frequency of Intradialytic Hypotension
时间窗: Baseline period through study completion, an average of 6 months
IDH is determined by review of blood pressures (measured every 30 minutes during dialysis), symptoms (recorded by the nurse during the dialysis treatment and reviewed at Q2 weekly face to face visits by the study team) and the need for intervention (targeted ultrafiltration goal was reduced; treatment was terminated early or saline given for intradialytic hypotension. IDH is defined by any 1 (or more of the following) 1) lowest intradialytic Systolic BP \<90 mm Hg or 2) intradialytic symptoms (cramps, lightheadedness, nausea +/-vomiting, diaphoresis, loss of consciousness or seizure) OR 3) intervention performed for symptoms of IDH or lowest intradialytic BP \<90 mm Hg. The # IDH events (meeting 1 or more of the 3 criteria above) per 100 treatments will be compared across treatment arms.
Frequency of ER visits and hospitalizations (safety)
时间窗: Baseline through study completion
The frequency of ER visits and hospitalizations will be ascertained at Q2 weekly study visits. The # of events per time at risk will be compared across treatment arms.
Frequency of patients treated to a dialysate Na 135 mEq/L at end of study (feasibility)
时间窗: Last 2 weeks of Follow-up
Among those assigned to Dialysate Na 135 mEq/l as the denominator, the # actually continuing to dialyze at this level during the last two weeks of study follow-up.
Dialysis Dysequilibrium (Safety)
时间窗: Baseline period through study completion, an average of 6 months
Ascertained via self-report on a questionnaire that asks about the frequency of symptoms suggestive of DD occurring during or immediately after dialysis. The symptoms are: headache, nausea +/- vomiting, confusion, drowsiness, muscle twitching, blurred vision. There are 5 response options ranging from never through to very often for each question. The questionnaire is administered at baseline, at 6 weeks, and Q3 months thereafter. The change in frequency of each symptom will be compared across arms.
次要结局
- Pre- and post-dialysis Plasma Sodium(Baseline period through study completion, an average of 6 months)
- Relative Blood Volume(Baseline period through study completion, an average of 6 months)
- Bioimpedance Analysis(Baseline period through study completion, an average of 6 months)
- Dialysate Sodium(Baseline period through study completion, an average of 6 months)
- Post Dialysis Weight(Baseline period through study completion, an average of 6 months)
- Estimated Dry Weight(Baseline period through study completion, an average of 6 months)
- Thirst and Xerostomia(Baseline through study completion, an average of 6 months)
- Interdialytic Weight Gain(Baseline period through study completion, an average of 6 months)
- Pre- and Post-dialysis Sitting Blood Pressure(Baseline period through study completion, an average of 6 months)
- Home Blood Pressure Monitoring(Baseline period through study completion, an average of 6 months)
- Sodium Loss during Dialysis(Baseline period through study completion, an average of 6 months)