At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study of the Use of Abdominal Compression Elastic Support (ACES) for Hemodialysis Patients
In Brief
A clinical study evaluating Abdominal Compression Elastic Support for Intradialytic Hypotension. Completed, enrolled 13 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
The ACES will be used for HD patients who have had IDH episodes in the last month. For these patients, the ACES will impose a compression pressure of 15 mmHg to compress the abdominal section over the last three hours of the HD treatment. This action can increase venous return and hence cardiac output to improve the cardiovascular function of the patient. In this way, the IDH episode may be prevented or reduced in severity. This use is much less cumbersome over the use of IAB in dealing with PDOH. We perform this trial study to show the use ACES is more effective than the Trendelenburg maneuver or the infusion of isotonic saline, for example.