Abdominal Compression Elastic Support (ACES)

NCT02159625 | Completed DMC

• 1 other identifier: G120243/S001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intradialytic Hypotension

Keywords

Abdominal Compression Elastic Support; Hemodialysis; hypotension; occurrence rate

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  4 hours of each HD session

Secondary Outcomes (1)

• The change in ALT and AST over the course of HD sessions with ACES

  4 hours for each HD session

Other Outcomes (7)

• Dry weight, pre- and post-dialysis weight (kg) of the control and ACES HD sessions.

  4 hours

• The achieved UF in comparison with the ultrafiltration (UF) goal set by the physician.

  4 hours

• Number and type of countermeasures employed to counter the IDH development in control and ACES sessions.

  4 hours

Study Arms (1)

Abdominal Compression Elastic Support

EXPERIMENTAL

To compress the abdomen at 15 mmHg for 3 hours during the course of hemodialysis treatment.

Device: Abdominal Compression Elastic Support

Interventions

Abdominal Compression Elastic Support DEVICE

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.

Also known as: ACES

Abdominal Compression Elastic Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Global Monitors, Inc.: lead
• University of Virginia: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (11)

• Coll E, Valles M, Torguet P, Bronsoms J, Mate G, Mauri JM. [Evaluation of plasma volume variation during different hemodialysis maneuvers]. Nefrologia. 2004;24(5):463-9. Spanish.

  PMID: 15648904 BACKGROUND

• Dheenan S, Henrich WL. Preventing dialysis hypotension: a comparison of usual protective maneuvers. Kidney Int. 2001 Mar;59(3):1175-81. doi: 10.1046/j.1523-1755.2001.0590031175.x.

  PMID: 11231376 BACKGROUND

• Lee JS. 1998 Distinguished Lecture: biomechanics of the microcirculation, an integrative and therapeutic perspective. Ann Biomed Eng. 2000 Jan;28(1):1-13. doi: 10.1114/1.249.

  PMID: 10645783 BACKGROUND

• Lindsay RM, Heidenheim PA, Nesrallah G, Garg AX, Suri R; Daily Hemodialysis Study Group London Health Sciences Centre. Minutes to recovery after a hemodialysis session: a simple health-related quality of life question that is reliable, valid, and sensitive to change. Clin J Am Soc Nephrol. 2006 Sep;1(5):952-9. doi: 10.2215/CJN.00040106. Epub 2006 Jul 6.

  PMID: 17699312 BACKGROUND

• Smit AA, Wieling W, Fujimura J, Denq JC, Opfer-Gehrking TL, Akarriou M, Karemaker JM, Low PA. Use of lower abdominal compression to combat orthostatic hypotension in patients with autonomic dysfunction. Clin Auton Res. 2004 Jun;14(3):167-75. doi: 10.1007/s10286-004-0187-x.

  PMID: 15241645 BACKGROUND

• Tanaka H, Yamaguchi H, Tamai H. Treatment of orthostatic intolerance with inflatable abdominal band. Lancet. 1997 Jan 18;349(9046):175. doi: 10.1016/S0140-6736(97)24003-1. No abstract available.

  PMID: 9111544 BACKGROUND

• Yamamoto N, Sasaki E, Goda K, Nagata K, Tanaka H, Terasaki J, Yasuda H, Imagawa A, Hanafusa T. Treatment of post-dialytic orthostatic hypotension with an inflatable abdominal band in hemodialysis patients. Kidney Int. 2006 Nov;70(10):1793-800. doi: 10.1038/sj.ki.5001852. Epub 2006 Sep 27.

  PMID: 17003821 BACKGROUND

• Palmer BF, Henrich WL. Recent advances in the prevention and management of intradialytic hypotension. J Am Soc Nephrol. 2008 Jan;19(1):8-11. doi: 10.1681/ASN.2007091006.

  PMID: 18178796 BACKGROUND

• Lee, JS, Current Status on Countermeasures for Intradialytic Hypotension, in "Tributes to Yuan-Cheng Fung on His 90th Birthday, Biomechanics, from Molecules to Man", ed. S. Chien et al, World Scientific, Singapore, 219-230, 2010.

  BACKGROUND

• Lee, JS, The Role of Microcirculation in Intradialytic Hypotension. Dialysis Times, 18:3-4, 2011

  BACKGROUND

• Denq JC, Opfer-Gehrking TL, Giuliani M, Felten J, Convertino VA, Low PA. Efficacy of compression of different capacitance beds in the amelioration of orthostatic hypotension. Clin Auton Res. 1997 Dec;7(6):321-6. doi: 10.1007/BF02267725.

  PMID: 9430805 BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kline Bolton, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 10, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

US (1)