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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Pediatric End Stage Renal Disease
• Intervention / Treatment: Procedure: Hemodialysis

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada
    • The Hospital for Sick Children
• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5 days per week hemodialysis; 5 days per week, 2 hours 20 minutes per session versus 3 days per week, 4 hours per session	Procedure: Hemodialysis; 5 days per week hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Systolic Blood Pressure	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: The Hospital for Sick Children; Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Benjamin L Laskin, MD, Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: May 9, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimate): May 11, 2011

Study Record Updates

• Last Update Posted (Estimate): December 31, 2013
• Last Update Submitted That Met QC Criteria: December 27, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: End Stage Renal Disease; Pediatric; Outcomes; Hemodialysis; Comparative Effectiveness
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 2010-0596