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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
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)
Conventional hemodialysis regimen
University of Florida
Jacksonville, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGNumber of Clinical events of safety
composite of all-cause Emergency Department visits, hospitalizations, or death
Time frame: year 2
EuroQOL-5D-5L scores Health-related quality of life Health-related quality of life and residual kidney function
Compare the effects of CMIHD and CHD - The descriptive system covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with 5 levels of severity in each dimension (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems - Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead.
Time frame: year 2
Trail Making Test B scores Health-related quality of life Health-related quality of life and residual kidney function
Patient participants' cognitive function will be assessed using change in Trail Making Test B score - The Trail Making Test measures your visual attention, mental flexibility, processing speed, and motor speed based on how quickly and accurately you connect dots in ascending order (either numerically or with alternating numbers and letters). The test can be used to diagnose dementia and other cognitive disorders - Higher scores indicate a higher degree of cognitive impairment
Time frame: Baseline and months 6, 12, 18, & 24
Standardized Outcomes in Nephrology (SONG) scores Health-related quality of life Health-related quality of life and residual kidney function
SONG-HD Fatigue score - The SONG-HD Fatigue measure consists of three items that assess (1) the effect of fatigue on life participation, (2) tiredness, and (3) level of energy. These dimensions are assessed on a four-point Likert scale indicating increasing severity, ranging from zero (not at all) to three (severely). Higher scores meaning higher severity
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Johns Hopkins University School of Medicine (JHUSM)
Baltimore, Maryland, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGUniversity of Mississippi Medical Center
Jackson, Mississippi, United States
RECRUITINGRenal Research Institute (RRI)
New York, New York, United States
RECRUITINGNorthwell Health
Queens, New York, United States
RECRUITINGUniversity of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGAtrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
RECRUITINGUniversity of Virginia (UVA)
Charlottesville, Virginia, United States
RECRUITINGTime frame: Baseline and months 6, 12, 18, & 24
Time to recover from hemodialysis (HD) Health-related quality of life Health-related quality of life and residual kidney function
Patient-reported functional status and fatigue will be assessed using Time to recover from HD
Time frame: Baseline and monthly up to 2 years
Caregiver burden Zarit Caregiver Burden Scores Health-related quality of life Health-related quality of life and residual kidney function
Caregiver burden will be assessed using the Zarit Caregiver Burden Scale - The ZBI consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. 9. Higher scores indicate greater burden. A score of 17 or more was considered high burden.
Time frame: Baseline, months 6, 12, 18, & 24
Change in urine output
Urine collections will be analyzed at the lab used by the dialysis center
Time frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2
Change in kidney urea clearance (mL/min/1.73 m2)
Urine collections will be analyzed at the lab used by the dialysis center
Time frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2
Change in kidney creatinine clearance (mL/min/1.73 m2)
Urine collections will be analyzed at the lab used by the dialysis center
Time frame: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2
Hospital free days per 100 patient-days
The duration of hospital-free days will be determined for each patient and calculated in the whole cohort per 100 patient-days. It is anticipated an array of hospitalization events for each participant, ranging from no hospitalization to frequent hospitalizations per study period. All periods of hospitalization, per each participant, will be analyzed. A period of hospitalization will be computed from date of hospital admission to the date of discharge. Hospital-free days may include one or more discrete time segments of non-hospitalization between periods hospitalization. The total hospital-free days per patient participant will be calculated as total study days - hospitalization days. Hospital-free days will be normalized per 100 patient-days.
Time frame: year 2
Illness Intrusiveness Rating Scale
Patients will rate the degree of interference caused by HD treatments on the following domains: health, diet, work, active and passive recreation, financial situation, relationship with spouse, sex life, family and other social relations, self-expression/self- improvement, religious expression, and community/civic involvement. Individual item ratings and the sum across ratings will be recorded. The total scale has a range of 13 (minimum intrusiveness) to 91 (extreme intrusiveness).
Time frame: Assessed at baseline and monthly up to 2 years
Employment status
The employment status for patients and caregivers will be assessed through surveys.
Time frame: Baseline and months 6, 12, 18 and 24