Peritoneal Dialysis, Continuous Ambulatory
Conditions
Keywords
fluid, edema
Brief summary
Bioimpedance-guided fluid management in peritoneal dialysis patients may provide better protection of residual renal function over 1 year period, compared with management guided by clinical information alone - such as blood pressure, body weight, and physician's physical examination.
Interventions
DEVICEBCM-guided fluid management
PROCEDUREFluid management based on the clinical information alone
Sponsors
Fresenius Medical Care Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age bwten 20 and 75 * peritoneal dialysis \> 4 weeks duration * written consent * daily urine output \> 500 ml
Exclusion criteria
* subjects who are contraindicated to the bioimpedance measurement (pacemaker insertion state, defibrillator state, amputee, prosthesis, metal implants) * pregnant women * subjects who are expected to discontinue peritoneal dialysis with one year * mixed dialysis modality (peritoneal + hemodialysis) * hypoalbuminemic subjects (serum albumin \< 3.3 g/dL) * high blood pressure (\> 160/100 mmHg despite antihypertensive medications) * severe heart failure (NYHA FC III, or IV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| delta GFR | baseline and 12th month | change of glomerular filtration rate from baseline to the 12th month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to anuria | over 12 months | time to the anuric state (urine volume \< 100cc/d) |
| echocardiographic parameters | 12 months period | parameters obtained by echocardiographic measurements such as left ventracular mass index (LVMi), E/e' ratio, left vetricular end-diastolic volume (LVEDP), left ventracular ejection fraction (LVEF), left atrial volume indx (LAVI) |
| GFR | at 12th month | glomerular filtration rate measured by urine collection, calculated by the mean of creatinine and urea clearance |
| cardiovascular event | over 12 months | fatal and nonfatal cardiovascular events - acute myocardial infarction (AMI), stroke, unstable angina, amputation, cardiovascular revascularization |
| BCM parameters | baseline and 12th month | parameters measured by body composition monitoring (BCM), such as overhydration(OH), extracellular water (ECW), extracellular-to-intracellular water ratio (ECW/ICW) |
| BP | 12th month | systolic, diastolic blood pressure, pulse pressure |
Countries
South Korea
Outcome results
None listed