Exploring Water-free Sodium Storage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Water free Na removal over the 5-day intervention
研究概览
简要总结
The overarching goal of this proposal is to definitively establish if acute water free Na storage and release occurs, if the amount stored/released is of a quantity that is physiologically relevant, and if the location is intracellular vs. extracellular.
详细描述
This study is designed as a an ultra-rigorous inpatient balance study. The main purpose of the study is to determine if significant mobilizable non- extracellular volume (ECV) Na storage occurs in humans. This is a randomized, blinded crossover study. Patients will be randomized to Na free 5% dextrose solution or 1.5% standard peritoneal dialysis (PD) fluid (Dianeal 1.5% low calcium PD solution with standard 132 mmol/L Na and osmolarity of 344 mOsmol/L) and will receive treatment for 5 days, following a 6 week wash out patient will return to undergo 5 days of alternate therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •ESRD Patients actively undergoing PD with a reliably functioning PD catheter
- •Systolic blood pressure > 130 mmHg
- •Serum sodium >135 mmol/L
- •daily urine output < 400ml
- •stable PD prescription for at least 2 months without requirement of 4.25% glucose PD solution
- •PD vintage of at least 6 months
- •Euvolemic as defined by the patient at their dry weight and free of any signs or symptoms of volume overload, per referring nephrologist
排除标准
- •Poorly controlled diabetes with hemoglobin A1C>9%
- •1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
- •Anemia with hemoglobin <8g/dL
- •Inability to give written informed consent or follow study protocol.
- •Urinary incontinence
- •Body weight < 60kg
- •gastrointestinal disease that causes diarrhea or expectation of sodium losses in stool.
- •use of amiodarone in the last 6 months (which will interfere with tissue iodine ascertainment).
研究组 & 干预措施
5% dextrose peritoneal dialysis, 2-hour dwell
Individuals will receive up to 2 liters of 5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days
干预措施: 5% Dextrose/Water (Drug)
1.5% dextrose peritoneal dialysis, 2-hour dwell
Individuals will receive up to 2 liters of 1.5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days
干预措施: 1.5% standard PD fluid (Drug)
结局指标
主要结局
Water free Na removal over the 5-day intervention
时间窗: Daily for 5 days
Water free Na removal will be calculated as \[Water Free Na= ((ΔTBW (L) \* serum Na (mmol/L)) - Na balance (mmol)\]. This will be compared between 5% dextrose Na removal period and 1.5% dextrose standard PD neutral Na balance period
次要结局
未报告次要终点