Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis
Wake Forest University Health Sciences
Summary
This study is to prospectively compare clinical effectiveness between clinically- matched incremental hemodialysis and conventional hemodialysis in patients with incident kidney dysfunction requiring dialysis and residual kidney function. The study will enroll 350 patients on chronic hemodialysis and 140 caregivers of enrolled patients. Patients will be randomized in 1:1 ratio to either incremental start hemodialysis or conventional hemodialysis. Caregivers will be followed along with patients for an average period of 2 years post randomization.
Description
This study will analyze the effects of differentiated care with individualized hemodialysis on patient health related quality of life, fatigue, employment, and caregiver burden in patients with Kidney dysfunction requiring dialysis (KDRD) and appreciable kidney function. This study will compare the outcomes in survival, hospitalization, preservation of the kidney function and quality of life between hemodialysis tailored to each patient needs (incremental) and conventional hemodialysis.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Patient eligibility Criteria: Inclusion Criteria: * Clinical Inclusion Criteria: * Age ≥ 18 years * Incident kidney dysfunction requiring dialysis (KDRD) started on maintenance, in-center hemodialysis (HD), or anticipated to be started on maintenance, in-center HD within the next 12 weeks * Has received ≤36 sessions of intermittent HD (i.e., on HD for ≤12 weeks) at the time patient is approached for potential study participation Residual Kidney Function Inclusion Criteria: * Kidney urea clearance \<2.0 mL/min * Urine volume# of ≥500 mL/24 h Exclusion Criteria: * Pre-HD serum K ≥5.8 mEq/L…
Interventions
- DeviceHemodialysis twice weekly
Frequency and duration of hemodialysis is tailored to the patient. Adjuvant pharmacotherapy is prescribed to maintain volume, electrolyte and acid-base homeostasis ( e.g., diuretics, sodium bicarbonate and potassium binding patiromer)
- OtherHemodialysis thrice weekly
Conventional hemodialysis regimen
Locations (10)
- University of FloridaJacksonville, Florida
- Emory UniversityAtlanta, Georgia
- Johns Hopkins University School of Medicine (JHUSM)Baltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- University of Mississippi Medical CenterJackson, Mississippi
- Renal Research Institute (RRI)New York, New York