Measuring Cardiovascular Stress in Patients on Hemodialysis Study II
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of intradialytic hypotensive (IDH) episodes that can be detected by the new rule set for CVInsight.
研究概览
简要总结
The overall goal is to evaluate the predictive accuracy of a measure of autoregulatory adequacy derived from CVInsight and compare it with other measures in recognizing hypotensive events during hemodialysis..
详细描述
Specific Aims are as follows:
- Assess the accuracy of a new rule set for CVInsight® in predicting intradialytic hypotensive episodes.
- Assess the comparative predictive accuracy of CVInsight® to other measures with regard to intradialytic hypotensive events.
- Assess estimated dry weight goals by monitoring post-dialytic vascular refill using CVInsight® and other measures.
- Assess hemodialysis(HD)-induced myocardial injury by monitoring the occurrence and frequency of arrhythmias and the levels of cardiac Troponin T.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility shall consist of the following:
- •Age ≥ 20 years old
- •Speaks and understands English, Spanish or Chinese
- •Provides Informed Consent
- •Patients with 20% intradialytic hypotensive events over the last two months.
- •Exclusion criteria for both groups:
- •Unstable hemodialysis patients per judgment of the clinician prior to the start of the treatment
- •Patients unable to have blood pressure cuff measured on the upper arm
- •Inability to wear monitor on forehead
- •Patients treated with sodium or ultrafiltration profiling and the patient's nephrologist is unwilling to alter this for the study treatments
- •Patients unwilling to shave the anterior chest
- •Patients with active infection of the upper chest wall tissue.
- •Patients with a deep brain stimulator, as it may disrupt the quality of the ECG data.
- •Patients who are unwilling to take short showers versus bathing during the 7 day period .
- •Patients who require intradialytic testing (ie transonic) during the monitored treatment.
排除标准
- 未提供
结局指标
主要结局
Number of intradialytic hypotensive (IDH) episodes that can be detected by the new rule set for CVInsight.
时间窗: 3-4 hours, for two hemodialysis session, or 6-8 hours total
IDH defined by at least one of the following: 1) Symptoms of hypotension: dizziness, cramping, altered consciousness, nausea +/- vomiting (new since beginning of session), chest pain, shortness of breath, seizure, diaphoretic. 2) Intervention administered due to IDH; relevant interventions:a) a reduction in ultrafiltration (UF) goal programmed at start of treatment (tx); b) admin. of IV fluid, e.g. saline, mannitol or hypertonic saline; c) stopping tx early due to IDH symptoms or event. 3) A significant drop in blood pressure, regardless of symptoms, defined as: * For pts w/ a pre-dialysis systolic blood pressure (SBP) \>110 mm Hg, an intra or post-dialysis SBP \<90 mm Hg, or a drop of \>40 mm Hg over 30 min. * For pts w/ a pre-dialysis SBP \<110, a decline in SBP \<85 mm Hg or 15 mm Hg or lower than their starting BP.
次要结局
- Amount of post-dialytic vascular refill as separately indicated by both CVInsight® and CRIT-LINE III.(At the end of each dialysis session after the ultrafiltration rate (UFR) has turned off.)
- The comparative, predictive accuracy of CVInsight® and CRIT-LINE III with regard to intradialytic hypotensive events.(3-4 hours, for two hemodialysis session, or 6-8 hours total)
- The occurrence and frequency of arrhythmias as indicated on the Zio ECG Patch and the levels of cardiac Troponin T, taken prior to each HD treatment. which are indicative HD-induced myocardial injury..(24 hours before first session of monitored dialysis to at least 24 hours after the second session on monitored dialysis sessions.)