Development of a Mathematical Model for the Evaluation of the Potassium Kinetic During and After Hemodialysis for the Potassium Profiling in the Dialysate to Prevent Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Kinetics of intra and extra-cellular concentrations of potassium during and after the dialytic session
研究概览
简要总结
The primary objective of the study is the development of a mathematical model for predicting potassium kinetics during and after the dialytic session.
The secondary objectives of the study are:
- the definition of a correlation between the kinetics of intra and extra-cellular concentrations of potassium during and after the dialytic session and the onset of arrhythmias;
- the use of the mathematical model to modify the blood concentration of potassium by acting on the composition of the dialysis bath in order to minimize the risk of onset of arrhythmias during and after dialysis.
详细描述
Type of study: spontaneous interventional, non-pharmacological, exploratory, prospective, monocentric. Eligible patients undergo hemodialytic treatment associated with the normal clinical pathway.
The study is divided into a Period A and a Period B. Period A includes the enrolment phase (Step 0), the laboratory and instrumental measurement phase (Step 1), the development phase of the mathematical model of potassium kinetics (Step 2) and the validation phase of the mathematical model (Step 3). Period B includes the phase of the use of the mathematical model for modulating the blood concentration of potassium and minimizing the risk of onset of arrhythmias during and after dialysis (Step 4).
Study population:
The study population will consist of 6 evaluable, outpatient patients with chronic kidney failure who need to perform hemodialysis thrice weekly for their survival.
In the case of drop out of a patient will be enrolled another patient to arrive at 6 patients evaluable both at the end of Period A and at the end of Period B of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •end stage renal failure on chronic hemodialysis
- •thrice weekly hemodialysis;
- •urine output < 100 ml/day;
- •low potassium diet (max 2 gr/day);
- •Age > 18 years;
- •Arterovenous fistula for hemodialysis with blood flow > 250 ml/min;
- •Written informed consent to participate.
排除标准
- •Intradialytic hypotension: 30% of dialysis sessions during the last month before enrollment with intradialytic systolic blood pressure reduction > 25 mmHg;
- •Need of intradialytic potassium administration;
- •Antiarrythmic drugs prescription;
- •Recent myocardial infarction;
- •Anemia (Hb < 8 gr%);
- •Enteritis.
结局指标
主要结局
Kinetics of intra and extra-cellular concentrations of potassium during and after the dialytic session
时间窗: The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.
This outcome is characterized by the measurements of intra and extracellular potassium. During dialysis starting at 8:00 a.m., measurements will be taken every 30 minutes. After 60 minutes of the end of dialysis, hourly measurements of intra-and extracellular potassium will be repeated.
次要结局
- Kinetics of urea during and after the dialytic session(The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.)
- Body Impedance Analysis(The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.)
- Kinetics of blood sugar during and after the dialytic session(The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.)
- ECG QT interval(The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.)
- Kinetics of bicarbonates during and after the dialytic session(The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.)
- Kinetics of sodium during and after the dialytic session(The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.)
- Sodium behaviour during dialysis(The expected time to complete the measurement phase on all 6 patients enrolled is 4 months.)
研究者
Gabriele Donati
Principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna