Hemodialysis, Pediatric End Stage Renal Disease
Conditions
Keywords
Hemodialysis, Pediatric, Outcomes, Comparative Effectiveness, End Stage Renal Disease
Brief summary
A health kidney works 24 hours a day, 7 days a week to remove toxins and fluid from the body. Many children with permanent kidney failure undergo dialysis, a life saving procedure that takes the place of a kidney. Currently, many children with permanent kidney failure only receive dialysis treatments 3 days a week in the hospital dialysis clinic. Children on dialysis have a markedly reduced life expectancy, with a life span 40-50 years shorter than their healthy counterparts. Survival for these children has not improved over the last 20 years. These data indicate that the current dialysis treatment strategy is unacceptable. This research project will study if more frequent dialysis, performed 5 days per week, will improve the health of children with permanent kidney failure compared to the current treatment strategy. Children will be treated with both traditional and more frequent dialysis schedules to measure improvements in their health and well being.
Interventions
PROCEDUREHemodialysis
5 days per week hemodialysis
Sponsors
Children's Hospital Medical Center, Cincinnati
The Hospital for Sick Children
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Current outpatient ESRD pediatric patients, 3-21 years old, receiving in-center chronic HD. * Patients have to be on chronic HD for at least 2 months before eligibility
Exclusion criteria
* Patients with a scheduled (with a specific transplant date) kidney transplant in the next 6 months * Patients scheduled to be switched to peritoneal dialysis in the next 6 months * Patients currently receiving \>3 days per week of hemodialysis * Patients currently receiving \>12 hours per week of hemodialysis * Anyone \<3 years of age would be excluded from the study, so our minimum anticipated patient weight would be about 11 kg * Patients \>21 years of age at enrollment * Patients receiving concomitant peritoneal dialysis * Patients with \<2 months on chronic HD * Patients with a temporary or femoral dialysis catheter * Patients who are not hypertensive (both not on blood pressure medication and with a SBP \<95th percentile for age, sex, and height) * Patients enrolled in an investigational drug trial involving blood pressure medication or any other clinical trial potentially affecting the primary outcome of the study Patients listed for a deceased donor transplant will not be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic Blood Pressure | up to 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Costs | up to 24 weeks |
| Quality of Life | up to 24 weeks |
| Adverse Events/Symptoms | up to 24 weeks |
| Bone Health | up to 24 weeks |
| Diastolic Blood Pressure | up to 24 weeks |
| Nutrition and Growth | up to 24 weeks |
| Echocardiogram measured left ventricular mass | every 3 months |
| School Performance | every 3 months |
| Inflammatory Markers | every 3 months |
| Anemia | up to 24 weeks |
Countries
Canada, United States
Outcome results
None listed