Prediction of Risk of Hypotension in Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Risk of PAS with symptom
研究概览
简要总结
The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration. The secondary objective is to study the impact of dysfunction in the mechanisms of compensation for decreased blood volume (heart disease, neuropathy, drugs) on the risk of intradialytic hypotension.
详细描述
The duration of the study is 4 weeks for each patient. It will first be carried out a spectral analysis of heart rate variability (CHU of Clermont Ferrand only) and a measurement of intracellular and extracellular volumes by bioimpedancemetry. During the next 9 sessions, the decrease in the VSR will be recorded using an optical haematocrit measurement system. Blood pressure and heart rate will be measured every 30 minutes using an automatic blood pressure monitor and whenever the patient's nurse deems it necessary.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •18 years old minimum patients
- •Patients with chronic end-stage renal failure
- •Patients treated with hemodialysis for at least 3 months, 3 times a week (duration of sessions 3 to 5 hours)
- •Patients with at least 2 episodes of intradialytic hypotension in the last month
- •Patients without acute events within 3 months prior to inclusion
- •Patients affiliated with or receiving social security benefits
排除标准
- •Hemoglobin levels outside the limits of measurement (<7 g/L or >15g/L)
- •Patients whose probable survival does not exceed 6 months
- •Patients with progressive acute pathology
- •Patient following another research protocol that may influence results
- •Patients with psychiatric pathology or cognitive impairments that make them unable to give informed consent
研究组 & 干预措施
Patients with chronic end-stage renal failure
干预措施: hemodialysis (Other)
结局指标
主要结局
Risk of PAS with symptom
时间窗: at 3 week
The primary outcome will be the risk of a decrease in PAS of more than 20 mmHg or a decrease in WFP of at least 10 mmHg associated with clinical symptomatology (vertigo, malaise, nausea or cramps)
次要结局
- Risk of PAS with symptom without symptom(at 3 week)
- risk of reduction of PAS below 90 mmHg (with or without symptoms)(at 3 week)
- risk of isolated symptoms caracterized by vertigo, discomfort, nausea or cramps(at 3 week)