Hemodialysis Complication
Conditions
Brief summary
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
Detailed description
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.
Interventions
DEVICEBioimpedance
Experimental: use overhydration value obtained by bioimpedance analysis to guide fluid management; the measurements will be obtained once per month
DEVICEControl
Placebo Comparator: the measurements will also be obtained once per month, but not revealed to the participants and the care providers
Sponsors
Cishan Hospital, Ministry of Health and Welfare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has received hemodialysis \>= 3 months * Has at least 1 pair of intact same-side upper extremity and lower extremity
Exclusion criteria
* Pregnant * With a cardiac pacemaker * With metallic implants that may interfere with measurements (cardiac stents acceptable)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events | From first bioimpedance analysis done to 1 year later | A composite of myocardial infarction, stroke and all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of hemodialysis sessions with intradialytic cramps or postdialytic cramps | From first bioimpedance analysis done to 1 year later | 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 |
| The number of hemodialysis sessions with intradialytic hypotension | From first bioimpedance analysis done to 1 year later | During hemodialysis, systolic blood pressures (SBP) drop to \<90mmHg, excluding those with baseline SBP \<90mmHg |
| The number of hemodialysis sessions with pitting edema | From first bioimpedance analysis done to 1 year later | Pitting edema is defined as grade 1 or more |
| The number of hemodialysis sessions with lung edema | From first bioimpedance analysis done to 1 year later | 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 |
| The number of hemodialysis sessions with non-function of arteriovenous shunt | From first bioimpedance analysis done to 1 year later | 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 |
Countries
Taiwan
Contacts
STUDY_CHAIRHan-Ming Kuo, Master
Cishan Hospital, MOHW, Taiwan
Outcome results
None listed