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The goal of this clinical trial is to learn if bioimpedance-guided fluid management can help decrease hemodialysis complications. The main questions it aims to answer are:
Does bioimpedance-guided fluid management decrease major cardiovascular events? Does bioimpedance-guided fluid management decrease other hemodialysis complications?
Participants will:
Take bioimpedance analysis once per month Adjust dry weight according to the analysis as possible in active group Blind the analysis results to the doctor and the patient in the control group
The goal of this clinical trial is to learn if bioimpedance-guided fluid management can decrease major adverse cardiovascular events (MACE), symptoms during hemodialysis, or other important outcomes such as vascular access patency, fluid overload admissions, etc. in maintenance hemodialysis patients. The main questions it aims to answer are:
Hypothesis 1: bioimpedance-guided fluid management decreases MACE Hypothesis 2: bioimpedance-guided fluid management decreases intradialytic hypotension, cramps and fatigue Hypothesis 3: bioimpedance-guided fluid management decreases need for urgent revascularization of vascular access for hemodialysis
Participants in the control group will decide their target weight according to physician's suggestion and the patient's preference, according to symptoms that are thought related to fluid status aberrancy (for example, edema, crackles for fluid overload, and cramps, intradialytic hypotension, fatigue for fluid insufficiency, given no other acute illness accountable for the symptoms and intradialytic weight gain not exceeding 5% of previous weight)
Participants in the active (bioimpedance) group will adjust their dry weight as those in the control group, if symptoms of fluid status aberrancy present. However, if no symptoms occur, they will receive adjustment according to measurements by bioimpedance analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioimpedance | Experimental | Use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month |
|
| Control | Placebo Comparator | Bioimpedance analysis done, but the results will be masked to the participants, care providers and outcome evaluators |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioimpedance | Device | Experimental: use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events | A composite of myocardial infarction, stroke and all-cause mortality | From first bioimpedance analysis done to 1 year later |
| Measure | Description | Time Frame |
|---|---|---|
| The number of hemodialysis sessions with intradialytic hypotension | During hemodialysis, systolic blood pressures (SBP) drop to <90mmHg, excluding those with baseline SBP <90mmHg | From first bioimpedance analysis done to 1 year later |
| The number of hemodialysis sessions with intradialytic cramps or postdialytic cramps |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han-Ming Kuo, Master | Cishan Hospital, MOHW, Taiwan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cishan Hospital, MOHW, Taiwan | Kaohsiung City | 842 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32295531 | Result | Liu L, Sun Y, Chen Y, Xu J, Yuan P, Shen Y, Lin S, Sun W, Ma Y, Ren J, Liu W, Lei J, Zuo L. The effect of BCM guided dry weight assessment on short-term survival in Chinese hemodialysis patients : Primary results of a randomized trial - BOdy COmposition MOnitor (BOCOMO) study. BMC Nephrol. 2020 Apr 15;21(1):135. doi: 10.1186/s12882-020-01793-x. | |
| 21688195 |
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The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
one year after the research published
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
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| Control | Device | Placebo Comparator: the measurements will also be obtained once per month, but not revealed to the participants and the care providers |
|
Cramps during hemodialysis or later in the hemodialysis day, excluding those who experience cramps on non-hemodialysis day; cramps in both extremities and abdomen are counted |
| From first bioimpedance analysis done to 1 year later |
| The number of hemodialysis sessions with pitting edema | Pitting edema is defined as grade 1 or more | From first bioimpedance analysis done to 1 year later |
| The number of hemodialysis sessions with lung edema | Lung edema is defined as either of the followings:
| From first bioimpedance analysis done to 1 year later |
| The number of hemodialysis sessions with non-function of arteriovenous shunt | Non-function means absence of thrill or bruit of the shunt, and/or needle could not be placed with adequate blood flow for dialysis; both arteriovenous fistula and graft are considered in this outcome | From first bioimpedance analysis done to 1 year later |
| Onofriescu M, Mardare NG, Segall L, Voroneanu L, Cusai C, Hogas S, Ardeleanu S, Nistor I, Prisada OV, Sascau R, Covic A. Randomized trial of bioelectrical impedance analysis versus clinical criteria for guiding ultrafiltration in hemodialysis patients: effects on blood pressure, hydration status, and arterial stiffness. Int Urol Nephrol. 2012 Apr;44(2):583-91. doi: 10.1007/s11255-011-0022-y. Epub 2011 Jun 19. |
| 23415416 | Result | Hur E, Usta M, Toz H, Asci G, Wabel P, Kahvecioglu S, Kayikcioglu M, Demirci MS, Ozkahya M, Duman S, Ok E. Effect of fluid management guided by bioimpedance spectroscopy on cardiovascular parameters in hemodialysis patients: a randomized controlled trial. Am J Kidney Dis. 2013 Jun;61(6):957-65. doi: 10.1053/j.ajkd.2012.12.017. Epub 2013 Feb 15. |
| 24583055 | Result | Onofriescu M, Hogas S, Voroneanu L, Apetrii M, Nistor I, Kanbay M, Covic AC. Bioimpedance-guided fluid management in maintenance hemodialysis: a pilot randomized controlled trial. Am J Kidney Dis. 2014 Jul;64(1):111-8. doi: 10.1053/j.ajkd.2014.01.420. Epub 2014 Feb 28. |
| 27620902 | Result | Huan-Sheng C, Yeong-Chang C, Ming-Hsing H, Fan-Lieh T, Chu-Cheng L, Tsai-Kun W, Hung-Ping C, Sze-Hung H, Hsien-Chang C, Chia-Chen L, Chun-Cheng H, Chun-Ting C, Hung-Hsiang L, Chun-Ju L, Paik-Seong L. Application of bioimpedance spectroscopy in Asian dialysis patients (ABISAD-III): a randomized controlled trial for clinical outcomes. Int Urol Nephrol. 2016 Nov;48(11):1897-1909. doi: 10.1007/s11255-016-1415-8. Epub 2016 Sep 12. |
| 30814786 | Result | Patel HV, Annigeri RA, Kowdle PC, Rao BS, Seshadri R, Balasubramanian S, Vadamalai V. Bioimpedance Spectroscopy-Guided Ultrafiltration Normalizes Hydration and Reduces Intradialytic Adverse Events in Hemodialysis Patients. Indian J Nephrol. 2019 Jan-Feb;29(1):1-7. doi: 10.4103/ijn.IJN_150_18. |