Fluid Overload
Conditions
Keywords
Hemodialysis, Body Composition Monitor
Brief summary
A reasonable and simple algorithm was used to guide the dry weight determination with Body Composition Monitor with the principle of Bioimpedance Spectroscopy (BCM-BIS) and analyze the feasibility of this algorithm and evaluate the influence of BCM-BIS-guided fluid management on the incidence of dialysis morbidities and clinical outcomes in maintenance hemodialysis (MHD) patients.
Detailed description
298 MHD patients in 6 hemodialysis centers in Taiwan were enrolled in this randomized controlled study. All the participants were randomized into study group ( dry weight (DW) determined by BCM-BIS) and control group ( dry weight determined by clinical symptoms) with stratification by diabetes mellitus and centers. Body composition monitor based on bioimpedance spectroscopy (BCM-BIS) was performed monthly and concomitant biochemical data and clinical outcomes were collected. Intra-dialysis complications were recorded in every dialysis session. Primary outcome was all-cause hospitalization. Secondary outcomes included 1) complications during DW adjustment 2) intra-dialysis morbidities 3) hypertension 4) mortality 5) acute fluid overload (AFO) or cardiovascular (CV)-related events. The clinical feasibility of the BCM-BIS algorithm was also inspected. Statistical methods: a software (SAS) 9.3 was used for statistical analysis in this study. R 3.0 was used for graphic presentation of parts of the results. Relative risk, incidence rate ratio and Fisher's exact test were used to compare the discrete outcomes in both groups. Survival analysis was used for time-related events. Repeated-measured and longitudinal data were analyzed with the generalized linear mixed model (GLMM) through the procedure for continuous variables (PROC MIXED) and for discrete variables (PROC GLIMMIX) in SAS.
Interventions
Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.
BEHAVIORALClinical judgement
Sponsors
Nephrocare AsiaPacific
An Hsin QingShui Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
MHD patients with age ≥ 18 and dialysis vintage ≥ 3 months
Exclusion criteria
1. coronary stents or pacemaker implantation 2. metallic devices in body, such as artificial joints or pins 3. contralateral or bilateral amputations 4. pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause Hospitalization | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications During DW Adjustment | 1 year | we wanted to compared whether the dialysis-related complications are different when DW (dry weight) is adjusted, no matter according to BCM (body composition monitor) results or clinical judgement, in both groups. The result is expressed as the percentage of months in which complications happened when DW adjustment presented (using total months which DW adjustments are present as denominator). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)
Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients. | 148 |
| Control Group Dry weight determined by clinical symptoms | 150 |
| Total | 298 |
Baseline characteristics
| Characteristic | Study Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 12.1 | 62.1 years STANDARD_DEVIATION 11.5 | 62.4 years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 83 Participants | 70 Participants | 153 Participants |
| Sex: Female, Male Male | 65 Participants | 80 Participants | 145 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 128 | 0 / 123 |
| serious Total, serious adverse events | 0 / 128 | 0 / 123 |
Outcome results
Primary
All-cause Hospitalization
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Group | All-cause Hospitalization | 0.52 hospitalizations per patient-year |
| Control Group | All-cause Hospitalization | 0.54 hospitalizations per patient-year |
Secondary
Complications During DW Adjustment
we wanted to compared whether the dialysis-related complications are different when DW (dry weight) is adjusted, no matter according to BCM (body composition monitor) results or clinical judgement, in both groups. The result is expressed as the percentage of months in which complications happened when DW adjustment presented (using total months which DW adjustments are present as denominator).
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Group | Complications During DW Adjustment | 11.76 % of months in which compli |
| Control Group | Complications During DW Adjustment | 30.88 % of months in which compli |