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

This study has been completed.
Sponsor:
Collaborators:
Children's Hospital Medical Center, Cincinnati
The Hospital for Sick Children
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01352455
First received: May 9, 2011
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Pediatric End Stage Renal Disease
Hemodialysis
Procedure: Hemodialysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of More Frequent In-Center Hemodialysis to Improve Outcomes in Pediatric End Stage Renal Disease

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Systolic Blood Pressure [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diastolic Blood Pressure [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Treatment Costs [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Adverse Events/Symptoms [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Bone Health [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Anemia [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Nutrition and Growth [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Echocardiogram measured left ventricular mass [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
  • School Performance [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
  • Inflammatory Markers [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: March 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352455

Locations
United States, Ohio
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Canada
The Hospital for Sick Children
Toronto, Canada
Sponsors and Collaborators
Children's Hospital of Philadelphia
Children's Hospital Medical Center, Cincinnati
The Hospital for Sick Children
Investigators
Principal Investigator: Benjamin L Laskin, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01352455     History of Changes
Other Study ID Numbers: 2010-0596
Study First Received: May 9, 2011
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Hemodialysis
Pediatric
Outcomes
Comparative Effectiveness
End Stage Renal Disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 16, 2014