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

Not Applicable

Completed

• Conditions: Hemodialysis; Pediatric End Stage Renal Disease
• Interventions: Procedure: Hemodialysis

• Registration Number: NCT01352455
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-27
• Last Update Posted: 2013-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
5 days per week hemodialysis	Hemodialysis	5 days per week, 2 hours 20 minutes per session versus 3 days per week, 4 hours per session

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	up to 24 weeks

Secondary Outcome Measures

Name	Time	Method
Nutrition and Growth	up to 24 weeks
Treatment Costs	up to 24 weeks
Quality of Life	up to 24 weeks
Adverse Events/Symptoms	up to 24 weeks
Anemia	up to 24 weeks
Bone Health	up to 24 weeks
Diastolic Blood Pressure	up to 24 weeks
Echocardiogram measured left ventricular mass	every 3 months
School Performance	every 3 months
Inflammatory Markers	every 3 months

Trial Locations

Locations (3)

Cincinnati Childrens Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

The Hospital for Sick Children; 🇨🇦 Toronto, Canada