More Frequent In-Center Hemodialysis in Pediatric End Stage Renal Disease

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of More Frequent In-Center Hemodialysis to Improve Outcomes in Pediatric End Stage Renal Disease

Conditions
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Pediatric End Stage Renal Disease, Hemodialysis

Intervention / Treatment
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* Procedure: Hemodialysis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5 days per week hemodialysis<br>5 days per week, 2 hours 20 minutes per session versus 3 days per week, 4 hours per session | Procedure: Hemodialysis<br>* 5 days per week hemodialysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure |  | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Blood Pressure |  | up to 24 weeks | 
| 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 | 
| Anemia |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Pediatric, Outcomes, Comparative Effectiveness, End Stage Renal Disease