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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
50
Experimental: use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month
Placebo Comparator: the measurements will also be obtained once per month, but not revealed to the participants and the care providers
Cishan Hospital, MOHW, Taiwan
Kaohsiung City, Taiwan
Major adverse cardiovascular events
A composite of myocardial infarction, stroke and all-cause mortality
Time frame: From first bioimpedance analysis done to 1 year later
The number of hemodialysis sessions with intradialytic hypotension
During hemodialysis, systolic blood pressures (SBP) drop to \<90mmHg, excluding those with baseline SBP \<90mmHg
Time frame: From first bioimpedance analysis done to 1 year later
The number of hemodialysis sessions with intradialytic cramps or postdialytic cramps
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
Time frame: 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
Time frame: 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: 1. Crackles in lungs, excluding those with overt history or signs of other diseases that cause crackles, such as pneumonia, atelectasis or pleural disease 2. Perihilar or interstitial pattern of infiltrations on chest X ray
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From first bioimpedance analysis done to 1 year later