Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event
研究概览
简要总结
The following pilot study will be undertaken to determine the effects of use of a zero-sodium peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared to a standard peritoneal dialysis solution.
详细描述
While heart failure (HF) is generally regarded as the inability of the heart to pump sufficient blood, on a population level, volume overload is the primary driver of morbidity and hospitalization. The signs and symptoms of volume overload are driven by water accumulation, which is initially driven by sodium retention. This overall goal of this study is to investigate the ability to remove sodium through use of a zero-sodium solution in peritoneal dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- •Patients actively undergoing peritoneal dialysis (PD) with a functioning PD catheter
- •PD vintage < 3 years
- •As judged by treating nephrologist to be at or above optimal volume status (i.e., not dehydrated)
排除标准
- •Uncontrolled diabetes with frequent episodes of severe hyperglycemia
- •Systolic blood pressure < 100 mmHg
- •Serum sodium < 130 mEq/L
- •1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
- •Anemia with hemoglobin <8 g/dL
- •Serum bicarbinate < 18 mEq/L
- •Anuric renal failure
- •Inability to give written informed consent or follow study protocol
研究组 & 干预措施
10% dextrose in sterile water
Patients randomized to this arm will undergo a two-hour dwell with 10% dextrose in sterile water at their first visit and Dianeal Low-Calcium with 4.25% Dextrose at their second visit.
干预措施: Two-hour dwell with 10% dextrose in sterile water (Drug)
10% dextrose in sterile water
Patients randomized to this arm will undergo a two-hour dwell with 10% dextrose in sterile water at their first visit and Dianeal Low-Calcium with 4.25% Dextrose at their second visit.
干预措施: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose (Drug)
Dianeal Low-Calcium with 4.25% Dextrose
Patients randomized to this arm will undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first visit and 10% dextrose in sterile water at their second visit.
干预措施: Two-hour dwell with 10% dextrose in sterile water (Drug)
Dianeal Low-Calcium with 4.25% Dextrose
Patients randomized to this arm will undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first visit and 10% dextrose in sterile water at their second visit.
干预措施: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose (Drug)
结局指标
主要结局
Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event
时间窗: Two hours
Protocol discontinuation will be defined by premature draining of the 10% dextrose peritoneal solution (or 4.25% standard PD solution) prior to the planned two hour drain.
次要结局
- Comparison of total sodium removed compared to baseline(Two hours)
研究者
Jeffrey Testani
Associate Professor of Medicine
Yale University