Clinical trial NCT01352455: More Frequent In-Center Hemodialysis in Pediatric End Stage Renal Disease
Official title: A Pilot Study of More Frequent In-Center Hemodialysis to Improve Outcomes in Pediatric End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric End Stage Renal Disease
Hemodialysis
Keywords: Hemodialysis
Pediatric
Outcomes
Comparative Effectiveness
End Stage Renal Disease
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
name: The Hospital for Sick Children
First posted: 2011-05-11
Enrollment: 7
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Diastolic Blood Pressure
timeFrame: up to 24 weeks
measure: Treatment Costs
timeFrame: up to 24 weeks
measure: Quality of Life
timeFrame: up to 24 weeks
measure: Adverse Events/Symptoms
timeFrame: up to 24 weeks
measure: Bone Health
timeFrame: up to 24 weeks
measure: Anemia
timeFrame: up to 24 weeks
measure: Nutrition and Growth
timeFrame: up to 24 weeks
measure: Echocardiogram measured left ventricular mass
timeFrame: every 3 months
measure: School Performance
timeFrame: every 3 months
measure: Inflammatory Markers
timeFrame: every 3 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Toronto
country: Canada
facility: The Hospital for Sick Children
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Benjamin L Laskin, MD
role: PRINCIPAL_INVESTIGATOR
References: