Abdominal Compression Elastic Support (ACES)

Completed · Not applicable

Conditions studied: Intradialytic Hypotension

In brief

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.

Key facts

Study ID

NCT02159625

Run by

Global Monitors, Inc.

People needed

13

Starts

2014-06-01

Expected to finish

2016-07-01

Last updated by the study team

2016-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 > 18.5.
• 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%).

You may not qualify if…

• • 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.

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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