Effects Of Volume Control Guided By Bioimpedance Spectroscopy On Blood Pressure And Cardiac Condition In Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Regression of left ventricular mass index (LVMI)
研究概览
简要总结
This prospective, randomized, controlled study aims to evaluate the usefulness of the new body composition monitor (BCM) device as a method to improve volume control in hemodialysis (HD) patients and compare the results with those obtained by conventional volume control modalities.
详细描述
The proposed prospective, randomized, controlled study intends to document the effect of volume control guided by BCM on blood pressure (determined both manually and 48-h ambulatory), need for anti-hypertensive medication, intra-dialytic complications, and left ventricular geometry and functions assessed by echocardiography. One hundred and seventy-six prevalent HD patients will be randomized into two arms: study group and control group.
In the study group, "overhydration (OH) in liters" will be estimated with the BCM (Body Composition Monitor, Fresenius Medical Care, Deutschland GmbH)at least once a month before a dialysis session in order to determine dry weight.
- If OH is positive value, we will try to reach dry weight by ultrafiltration without regard to the level of blood pressure.
- If OH is negative value , and:
- Systolic blood pressure is < 100 mmHg with/or intradialytic hypotension episodes and/or clothing and/or erythrocytosis ( htc> 36 %); we will increase dry weight accordingly.
- Systolic blood pressure is normal (100-150 mmHg) without intradialytic hypotension episodes and clothing and erythrocytosis; we will not change dry weight.
- Systolic blood pressure normal (100-150 mmHg) with intradialytic hypotension episodes and/or clothing and/or erythrocytosis; we will increase dry weight.
- Systolic blood pressure> 150 mmHg we will perform a captopril test (CT) If the CT is positive we will use ACE inhibitors / ARBs as anti hypertensive drugs and dry weight will be increased if intradialytic hypotension episodes and/or clothing and/or erythrocytosis ( htc> 36 %) are also present
If the CT is negative we will repeat the BCM measurement and if it gives same results we will perform ABPM for confirmation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18-year,
- •Maintenance bicarbonate HD scheduled thrice weekly (12 hours/week),
- •Willingness to participate in the study with a written informed consent.
排除标准
- •Presence of a cardiac stent, pacemaker or defibrillator ,
- •Artificial joints, pin or amputation
- •Permanent or temporary catheters (may affect BCM measurement),
- •Being scheduled for living donor renal transplantation,
- •Presence of serious life-limiting co-morbid situations, like malignancy, uncontrollable infection, end-stage cardiac, pulmonary, or hepatic disease,
- •Pregnancy or lactating,
- •Current use of investigational drugs or participation in an interventional clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial,
- •Mental incompetence.
结局指标
主要结局
Regression of left ventricular mass index (LVMI)
时间窗: 1 year
次要结局
- Changes in post-dialysis body weight(1 year)
- Achievement of normal blood pressure level without using anti-hypertensive medication(1 year)
- Decrease in left atrial volume(1 year)
- Hematocrit and related rHu-EPO doses(1 year)
- Serum levels of albumin and Hs-CRP(1 year)
- Plasma level of pro-BNP(1 year)
