Using Intradialytic Systolic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients: A Validation Study and Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Mean Ambulatory Systolic Blood Pressure
研究概览
简要总结
This study is an open label randomized clinical trial that comparing intradialytic blood pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid management of maintenance hemodialysis patients. It also includes a cross sectional component evaluating the associations between intradialytic blood pressure slopes ascertained over 2 week periods with measurements of extracellular water/body weight obtained with multifrequency bioimpedance spectroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 18 years
- •End Stage Renal Disease on Maintenance Hemodialysis
- •Hypertension defined as systolic blood pressure > 140 mmHg pre-dialysis or >130 mmHg post dialysis
排除标准
- •Hemodialysis Vintage < 1 month
- •Pregnancy
- •Nadir Systolic Blood Pressure < 95 mmHg
- •Pre or Post dialysis systolic blood pressure > 180 mmHg
- •Decrease in systolic blood pressure >60 mmHg from pre to post dialysis
- •Ultrafiltration rate >13 mL/kg/hr
- •Peridialytic Midodrine Use
- •Intradialytic Clonidine use
- •Documented Antihypertensive Medication Non-adherence
- •Bioimpedance will not be peformed on patients with
- •amputated arms or legs
- •cardiac defibrillator or pacemaker
- •presence of metal prostheses
研究组 & 干预措施
Standard Care
This arm of subjects will have all aspects of fluid management and dialysis management managed by the his/her individual nephrologist
IBPS Group
This group will have ultrafiltration prescriptions dictated by a pre-specified protocol that is based on monthly assessment of intradialytic blood pressure slopes obtained over a two week period.
干预措施: Intradialytic Blood Pressure Slope Based Ultrafiltration (Other)
结局指标
主要结局
Change in Mean Ambulatory Systolic Blood Pressure
时间窗: Baseline, 4 months
The change in mean systolic ambulatory blood pressure from study baseline to completion (4 months)
次要结局
- Change in Extracellular Volume/Body Weight Ratio(Baseline, 4 months)
研究者
Peter Van Buren
Assistant Professor
University of Texas Southwestern Medical Center