Effects of Hemodialysis With Cooled Dialysate on High Sensitive Cardiac Troponin I (TnI) and Brain Natriuretic Peptide (NT proBNP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Comparison of hypothermic dialysis with routine dialysis in terms of hemodynamic stability
研究概览
简要总结
Hemodialysis (HD) triggers recurrent and cumulative ischemic insults to the brain and the heart. Cooled dialysate may have a protective effect on major organs and improve hemodynamic tolerability of dialysis. The aim of the study was to compare HD with cooled dialysate with routine dialysis in terms of hemodynamic stability and levels of high sensitivity Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with renal insufficiency treated with dialysis for a period of at least three months.
排除标准
- •Patients who experienced myocardial infarction during the three months prior to the start of the study
- •Patients who underwent vascular surgery during the last month
- •Patients who experienced chest pain at rest during the last week before the start of the trial - Patients who had to discontinue dialysis prematurely due to hemodynamic instability.
结局指标
主要结局
Comparison of hypothermic dialysis with routine dialysis in terms of hemodynamic stability
时间窗: one year
For each patient, four blood pressure measurements including systolic blood pressure, diastolic blood pressure and mean arterial pressure were performed at the beginning, after 2 hours, after 3 hours after 4 hours (end of hemodialysis).
Assessments of the levels of high sensitivite Troponin I (hs-TnI) and N-terminal pro b-type natriuretic peptide (NTproBNP) post dialysis
时间窗: 6 months
Blood samples were collected at the beginning of the dialysis session, and a second sample was taken in the last 5 minutes of hemodialysis in order to evaluate the relationship between hemodialysis with cooled dialysate (hypothermic dialysis) and the myocardial markers hs-TnI and NTproBNP and to monitor hypothermic hemodiaysis treatment response.
次要结局
未报告次要终点
研究者
Osamah Hussein
Head of Internal Medicine A
Ziv Hospital