Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nephrocare AsiaPacific | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Active Comparator | Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool) |
|
| Control group | Placebo Comparator | Dry weight determined by clinical symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioimpedance Spectroscopy | Device | Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Hospitalization | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
MHD patients with age ≥ 18 and dialysis vintage ≥ 3 months
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group | Dry weight determined by clinical symptoms |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All-cause Hospitalization | Posted | Number | 95% Confidence Interval | hospitalizations per patient-year | 1 year |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lim Paik-Seong | Department of Nephrology, Tungs' Taichung MetroHarbor Hospital, Taichung, Taiwan | 886-4-26581919 | jamespslim@gmail.com |
Not provided
| ID | Term |
|---|---|
| D004487 | Edema |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Clinical judgement | Behavioral |
|
| 1 year |
Dry weight determined by clinical symptoms |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| 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). | Posted | Number | % of months in which compli | 1 year | months when dry weight adjustment happen | Participants |
|
|
|
| 0 |
| 128 |
| 0 |
| 128 |
| EG001 | Control Group | Dry weight determined by clinical symptoms | 0 | 123 | 0 | 123 |
Not provided
Not provided
Not provided