Incremental Hemodialysis: The TwoPlus Trial
Purpose
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.
Condition
- End-Stage Kidney Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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, 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This study is a randomized parallel-group type 1 hybrid study
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Clinically-matched Incremental Hemodialysis ( CMIHD) |
Randomized group to have hemodialysis prescription tailored based on residual kidney function and clinical manifestations starting at twice weekly. |
|
|
Active Comparator Conventional Hemodialysis (CHD) |
Randomized group to conventional three times a week hemodialysis. |
|
Recruiting Locations
Boston 4930956, Massachusetts 6254926 02114
More Details
- Status
- Recruiting
- Sponsor
- Wake Forest University Health Sciences
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.