End stage renal disease with hemodialysis Urological and Genital Diseases
Conditions
Interventions
The study data will be exported directly from the patient’s electronic medical record system (Versia®) by Renal Therapy Services. The study data that normally do not belong to the patient’s Versia re
Sponsors
Baxter Healthcare Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject or a legally authorized representative has signed the written informed consent form 2. The subject is = 18 years old 3. The subject has been diagnosed with CKD with more than 90 days in chronic hemodialysis 4. The subject has been receiving expanded hemodialysis treatment in a renal clinic of the RTS network with the Theranova® dialyzer 5. The subject has been undergoing a hemodialysis schedule at least 3 times per week and a minimum duration of 4 hours per session 6. The subject is being dialyzed in a renal clinic that meets water quality standards established by the Association for the Advancement of Medical Instrumentation (AAMI)
Exclusion criteria
Exclusion criteria: 1. The subject has a life expectancy of no more than six months as determined by his/her attending physician 2. The subject has or had an active infection diagnosed in the past 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness assessments: 1. The rates of hospitalization and hospital days 2. Mortality rates 3. Rates of non-fatal cardiovascular events Exported directly from the patient’s electronic medical record system; the follow-up is 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient-reported outcome measures: individual item scores and total scores for Dialysis Symptom Index (DSI) and quality of life (KDQOL-36™) and frequency of restless legs diagnosis 2. Number of uses of phosphorus chelating agents and plasma phosphorus level 3. ESA dose, type and route of administration and hemoglobin level 4. Number of antihypertensive drugs and systolic and diastolic blood pressure 5. Intake of tablets/pills per day and KDQOL-36™ Score 6. Use of nutritional supplements and nutritional status Exported directly from the patient’s electronic medical record system; the follow-up is 1 year. | — |
Countries
Colombia
Outcome results
None listed