Incremental Hemodialysis: The TwoPlus Trial
- Conditions
- End-Stage Kidney Disease
- Interventions
- Other: Hemodialysis thrice weeklyDevice: Hemodialysis twice weekly
- Registration Number
- NCT05828823
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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
- Pre-HD serum K ≥5.8 mEq/L, Na ≤125 mEq/L, or bicarbonate level ≤17 mEq/L
- Requirement or anticipated requirement of high-volume ultrafiltration
- Unable or unwilling to follow the study protocol for any reason
- Known pregnancy or planning to attempt to become pregnant or lactating women
- Estimated survival or dialysis modality change or center transfer <6 months
Caregiver Eligibility Criteria:
- be at least 18 years old
- be the main caregiver (at patient's choice)
- be a close relative of the patient (spouse, child, sibling, parent, grandchild)
- have no known psychiatric and neurologic disorders (through direct inquiry from the person)
- not be a member of the medical or healthcare team
- not be the caregiver for another patient with chronic illness
- not have experienced severe life events within prior 3 months of enrollment (through direct inquiry from the person)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Hemodialysis (CHD) Hemodialysis thrice weekly Randomized group to conventional three times a week hemodialysis. Clinically-matched Incremental Hemodialysis ( CMIHD) Hemodialysis twice weekly Randomized group to have hemodialysis prescription tailored based on residual kidney function and clinical manifestations starting at twice weekly.
- Primary Outcome Measures
Name Time Method Number of Clinical events of safety year 2 composite of all-cause Emergency Department visits, hospitalizations, or death
- Secondary Outcome Measures
Name Time Method Trail Making Test B scores Health-related quality of life Health-related quality of life and residual kidney function Baseline and months 6, 12, 18, & 24 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
EuroQOL-5D-5L scores Health-related quality of life Health-related quality of life and residual kidney function year 2 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.
Change in urine output Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2 Urine collections will be analyzed at the lab used by the dialysis center
Illness Intrusiveness Rating Scale Assessed at baseline and monthly up to 2 years 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).
Employment status Baseline and months 6, 12, 18 and 24 The employment status for patients and caregivers will be assessed through surveys.
Caregiver burden Zarit Caregiver Burden Scores Health-related quality of life Health-related quality of life and residual kidney function Baseline, months 6, 12, 18, & 24 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.
Change in kidney creatinine clearance (mL/min/1.73 m2) Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2 Urine collections will be analyzed at the lab used by the dialysis center
Time to recover from hemodialysis (HD) Health-related quality of life Health-related quality of life and residual kidney function Baseline and monthly up to 2 years Patient-reported functional status and fatigue will be assessed using Time to recover from HD
Change in kidney urea clearance (mL/min/1.73 m2) Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2 Urine collections will be analyzed at the lab used by the dialysis center
Standardized Outcomes in Nephrology (SONG) scores Health-related quality of life Health-related quality of life and residual kidney function Baseline and months 6, 12, 18, & 24 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
Hospital free days per 100 patient-days year 2 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.
Trial Locations
- Locations (8)
University of Florida
🇺🇸Jacksonville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Johns Hopkins University School of Medicine (JHUSM)
🇺🇸Baltimore, Maryland, United States
Renal Research Institute (RRI)
🇺🇸New York, New York, United States
University of North Carolina Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Atrium Health Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States
Cleveland Clinic, Case Western Reserve University (CWRU)
🇺🇸Cleveland, Ohio, United States
University of Virginia (UVA)
🇺🇸Charlottesville, Virginia, United States