Comparative Effectiveness of an Individualized Model of Hemodialysis Versus Conventional Hemodialysis
概览
- 阶段
- 不适用
- 干预措施
- Hemodialysis thrice weekly
- 疾病 / 适应症
- End-Stage Kidney Disease
- 发起方
- Wake Forest University Health Sciences
- 入组人数
- 350
- 试验地点
- 18
- 主要终点
- Number of Clinical events of safety
- 状态
- 招募中
- 最后更新
- 3个月前
概览
简要总结
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.
详细描述
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.
研究者
入排标准
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Conventional Hemodialysis (CHD)
Randomized group to conventional three times a week hemodialysis.
干预措施: Hemodialysis thrice weekly
Clinically-matched Incremental Hemodialysis ( CMIHD)
Randomized group to have hemodialysis prescription tailored based on residual kidney function and clinical manifestations starting at twice weekly.
干预措施: Hemodialysis twice weekly
结局指标
主要结局
Number of Clinical events of safety
时间窗: year 2
composite of all-cause Emergency Department visits, hospitalizations, or death
次要结局
- 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)
- EuroQOL-5D-5L scores Health-related quality of life Health-related quality of life and residual kidney function(year 2)
- Change in urine output(Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, and Year 2)
- Illness Intrusiveness Rating Scale(Assessed at baseline and monthly up to 2 years)
- Employment status(Baseline and months 6, 12, 18 and 24)
- 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)
- 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)
- 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)
- 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)
- 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)
- Hospital free days per 100 patient-days(year 2)