Intradialytic Hypotension Clinical Trial
— ACESOfficial title:
A Study of the Use of Abdominal Compression Elastic Support (ACES) for Hemodialysis Patients
Verified date | August 2016 |
Source | Global Monitors, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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%). Exclusion Criteria: - • 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
Global Monitors, Inc. | University of Virginia |
United States,
Coll E, Vallès M, Torguet P, Bronsoms J, Maté G, Mauri JM. [Evaluation of plasma volume variation during different hemodialysis maneuvers]. Nefrologia. 2004;24(5):463-9. Spanish. — View Citation
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. — View Citation
Dheenan S, Henrich WL. Preventing dialysis hypotension: a comparison of usual protective maneuvers. Kidney Int. 2001 Mar;59(3):1175-81. — View Citation
Lee JS. 1998 Distinguished Lecture: biomechanics of the microcirculation, an integrative and therapeutic perspective. Ann Biomed Eng. 2000 Jan;28(1):1-13. Review. — View Citation
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.
Lee, JS, The Role of Microcirculation in Intradialytic Hypotension. Dialysis Times, 18:3-4, 2011
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. Epub 2006 Jul 6. — View Citation
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. — View Citation
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. — View Citation
Tanaka H, Yamaguchi H, Tamai H. Treatment of orthostatic intolerance with inflatable abdominal band. Lancet. 1997 Jan 18;349(9046):175. — View Citation
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. Epub 2006 Sep 27. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Dry weight, pre- and post-dialysis weight (kg) of the control and ACES HD sessions. | A student paired t-test will be used to examine whether the use of ACES alters the these weights beyond the control ones. | 4 hours | No |
Other | The achieved UF in comparison with the ultrafiltration (UF) goal set by the physician. | This is an assessment on the effectiveness of HD process and on whether it is affected with the use of ACES. A student paired t-test will be used. | 4 hours | No |
Other | Number and type of countermeasures employed to counter the IDH development in control and ACES sessions. | This is an assessment on the effectiveness of ACES on whether it reduces the need to call for additional countermeasures. A student t-test will be used to analyze the number data. | 4 hours | No |
Other | Prescribed and delivered time of the HD session. | This is an assessment on the effectiveness of HD process and on whether it is affected with the use of ACES. On the latter, a student paired t-test will be used to compare the difference between prescribed and delivered time to find out whether the difference is altered for the ACES session. | 4 hours | No |
Other | Achieved Kt/V | This is an assessment on the effectiveness of HD process and on whether the set Kt/V is achieved for ACES sessions. A student paired t-test will be used. | 4 hours | No |
Other | Recovery time after HD session | The recovery time will be considered as a quality assessment of the HD treatment. By a student paired t-test, we may find out whether the use of ACES will lead to faster recovery for the patients. | at 4 hours after the HD session | No |
Other | Record of patient's tolerance to the use of ACES, comments on discomfort associated with HD process, and likelihood to use ACES for future HD treatments. | These parameters, in the form of yes or no, are subjectively provided by the patient for the investigators to assess whether the ACES will induce discomfort to the patient taking HD and whether they want to use ACES again. | 4 hours | No |
Primary | 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 | No |
Secondary | The change in ALT and AST over the course of HD sessions with ACES | One blood sample is taken before the start of the HD session and the other at the end of the session. The investigators then measure the ALT and AST level of the samples. A student paired t-test will be used to examine whether the use of ACES increases the level of ALT and AST. If the result indicates insignificant increase, the investigators can then conclude that the use of ACES imposes no damage to the liver. | 4 hours for each HD session | Yes |
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