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

NCT ID: NCT01352455

Last Updated: 2013-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5 days per week hemodialysis

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

Group Type: EXPERIMENTAL

Hemodialysis

Intervention Type: PROCEDURE

5 days per week hemodialysis

Interventions

Hemodialysis

5 days per week hemodialysis

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin L Laskin, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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

Countries

United States; Canada

Other Identifiers

2010-0596

Identifier Type: -

Identifier Source: org_study_id