A Study of the Use of Abdominal Compression Elastic Support (ACES) for Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- The number of HD sessions or hourly periods of the sessions being classified as IDH episode, which indicates that the patient's SBP decreases more than 20 mmHg from the SBP at the start of HD session or the patient experiences hypotensive symptoms.
研究概览
简要总结
Hemodialysis (HD) patients with end stage renal disease (ESRD) experience higher rates of cardiovascular (CV) morbidity and mortality than do the general population and many populations with other chronic diseases. This exceptional risk is explained in part by known risk factors, such as diabetes, hypertension, and other uremia-related factors, including vascular calcification and stiffness, autonomic dysfunction, and a high burden of circulating inflammatory mediators. Recent studies suggest that blood pressure variability, especially intra-dialytic hypotension (IDH) is the most significant risk factor for these CV events. Studies have also shown that the use of IAB is capable of improving cardiovascular function for avoiding or minimizing the development of an orthostatic hypotensive episode (OHE) in patients with autonomic dysfunction, orthostatic hypotension (OH) in diabetes patients and children with orthostatic intolerance, and post-dialytic orthostatic hypotension (PDOH).
The investigators propose a study to examine the use of an abdominal compression elastic support (ACES) to prevent the development of IDH in patients who are known to be prone to these episodes. The ultimate goal is to facilitate more effective and safer dialysis therapy. The ACES has a configuration that is similar to a back-support work belt or an inflatable abdominal band (IAB). All of these devices are wrapped around to compress the abdomen at the waist.
详细描述
I. Study Design: Biomedical
- Controls will be used. For the safety of ACES five healthy subjects will be used as controls to assess the safety and tolerability of the device. The regular HD treatments of each study patient will serve as their own control in assessing the effect of ACES use on their HD treatments. The control data are derived from the treatment logs of four to eight HD regular treatments taken by the patient.
- The study design is an open trial.
- No placebo is involved
- This is a single center study to be done only at the Medical Center of University of Virginia (UVa).
II. Human Participants Ages: 18 or older Sex: Male and Female Race: All
Subjects or Patients:
- 5 healthy subjects and 20 dialysis patients to complete protocol.
- There could be a 50% drop out rate for the dialysis patients.
- 30 (Up to 5 healthy subjects and Up to 35 dialysis patients) will be enrolled at all sites
- All 30 subjects and patients will sign a consent form under this protocol.
- The estimated time line for the study is 100% enrollment within 10 months III. Statistical Considerations
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be able to give informed consent for participation in this study
- •Age ≥ 18 years
- •A body weight > 100 lb or a body mass index > 18.
- •End-stage renal disease with hemodialysis in-center three times per week
- •Not missing any treatments in the preceding two weeks and in compliance with instructions from the health care provider.
- •In the last month had at least two episodes of IDH (defined as having hypotensive symptoms such as dizziness, fainting, headache, nausea, vomiting, cramping, weakness, blurry vision and/or a decrease in systolic blood pressure (SBP) of more than 20 mmHg).
- •Hemoglobin greater than or equal to 9.0 g/dL (hematocrit 27%) to hemoglobin of 15.0 g/dL (hematocrit 45%).
排除标准
- •• Pregnancy (self-reported)
- •Allergic to nylon, polyesters and latex.
- •Not able to understand the English language
- •Not able to disengage the ACES from compression
- •Having an excessively low systolic blood pressure (SBP which is less than 90 mmHg)
- •Hemoglobin less than 9.0 g/dL or greater than 15 g/dL
- •Excessive intra-abdominal fluid pressure
- •Respiratory distress
- •Bleeding in the chest and abdomen
- •Bleeding dyscrasia causing serious coagulation problem
- •Raised intra-abdominal pressure
- •Having the following cardiovascular, pulmonary and abdominal complications:
- •Systolic congestive heart failure, defined as a systolic ejection fraction of less than 25%
- •Coronary artery disease defined as having a history of myocardial infarction or hemo-dynamically significant stenosis on cardiac catheterization or acute or chronic angina
- •Circulatory shock
- •Head trauma and/or abdominal trauma in the past three months
- •Mesenteric ischemia
- •Active foot ulcer
- •Pulmonary edema
- •Uncontrolled Hypertension (defined as systolic pressure of 180 mm Hg or a diastolic pressure of 110 mm Hg or higher) - using the average blood pressures obtained at one prior recent dialysis session and the average blood pressures obtained at the screening trial session for ACES.
- •Liver disease as defined as an elevated ALT, AST, and Alkaline Phosphatase 2.5 times the upper limit of normal on a prior lab from medical records.
- •INR > 1.5 or use of coumadin
- •Platelets < 100
- •Active infection
- •The need to use anti-hypotensive drugs on the days the ACES belt is applied.
- •If the average systolic blood pressure with anti-hypotensive drugs or without and made before hemodialysis treatment is less than 90 mmHg, then the ACES session will be postponed to the next treatment. If similar hypotension situation occurs in the next ACES/hemodialysis treatment, then the subject will be taken out of the ACES trial and be considered a screen fail.
结局指标
主要结局
The number of HD sessions or hourly periods of the sessions being classified as IDH episode, which indicates that the patient's SBP decreases more than 20 mmHg from the SBP at the start of HD session or the patient experiences hypotensive symptoms.
时间窗: 4 hours of each HD session
This is an efficacy measure of the use of ACES to alleviate IDH. The investigators count the number of sessions with IDH and non-IDH sessions for the control ones and ACES sessions and use the Chi-square analysis to answer whether there is a significant reduction in the occurrence frequency of IDH. The investigators will examine in a similar way the counts based on the IDH development in the four hourly periods within a HD treatment for controls and those with ACES.
次要结局
- The change in ALT and AST over the course of HD sessions with ACES(4 hours for each HD session)