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

NCT01352455 | Completed

• 1 other identifier: 2010-0596
• Study Type: interventional
• Target: 7
• Locations: 2 countries
• Sites: 3

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.

Conditions

Pediatric End Stage Renal Disease; Hemodialysis

Keywords

Hemodialysis; Pediatric; Outcomes; Comparative Effectiveness; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  up to 24 weeks

Secondary Outcomes (10)

• 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

Study Arms (1)

5 days per week hemodialysis

EXPERIMENTAL

5 days per week, 2 hours 20 minutes per session versus 3 days per week, 4 hours per session

Procedure: Hemodialysis

Interventions

Hemodialysis PROCEDURE

5 days per week hemodialysis

5 days per week hemodialysis

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Children's Hospital Medical Center, Cincinnati: collaborator
• The Hospital for Sick Children: collaborator

Study Sites (3)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

The Hospital for Sick Children

Toronto, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Benjamin L Laskin, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 11, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

US (2); CA (1)