The Effect of Head Out Water Immersion During Dialysis on Clinical Parameters, Hemodynamic Parameters, and Hormonal Parameters in 10 Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- symptomatic hypotension during dialysis
研究概览
简要总结
Immersion to the neck before and during hemodialysis session may increase intravascular volume, potentiate the ability to ultrafiltrate excess water, with less symptoms of shock, muscle crumps etc.
The aim of the present study is to compare blood volume, hemodynamic and endocrine parameters of chronic ESRD patients undergoing forth dialysis session in water immersion vs. control regular session.
详细描述
10 chronic hemodialysis patients, treated in the hemodialysis unit of Asaf-Harofeh Medical Center will be enrolled in the study.
Hemoglobin and albumin will be detected at baseline, and a recent (less than one year) echo will be used for the detection of ejection fraction.
The study will be a cross over study. Each set of studies will consist of two dialysis sessions, an immersion session, and a dry, non-immersion session. The study sessions will be short, 3 hours sessions with 250-350 ml/min blood flow (depends on the patients access) dialysate flow was 500 ml/min and dialysate sodium was 137meq/l. The temperature of the dialysate will be adjusted to 37°C and its composition as follows: Na+ = 137 mEq/L, K+ = 2.0 mEq/L, Ca2+ = 3.0 mEq/L, Mg2+ = 1.0 mEq/L, HCO3-= 30 mEq/L, glucose =100 mg/dL, CH3COO-= 8 mEq/L. The sodium concentration will be constant during treatment.
Ultrafiltration will be determined as the mean of UF during the ten previous sessions±10% according to the patients weight on admission. The immersed and dry session will be done in the midweek sessions, in random order, at least one week apart from each other.
Head-Out Water Immersion
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
- None
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic hemodialysis patients
排除标准
- •anemia (HB<10) active infectious disease cognitive impairment dialysis access installed in the leg inability to cooperate with the study procedure Clinically evident overhydrated patients(edema, pulmonary congestion, pulmonary effusion)
结局指标
主要结局
symptomatic hypotension during dialysis
时间窗: 3 hours
a decrease of systolic BP of 22mmHG or more or decrease of diastolic BP of 10 mmHg or more accompanied with symptoms of muscle crumps, presyncope or syncope
次要结局
- blood pressure changes compared to baseline(3 hours every 15 min)
- Atrial natriuretic peptide change compared to baseline(0, 1, 3 hours)