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

May 9, 2011
December 27, 2013
March 2011
September 2013   (final data collection date for primary outcome measure)
Systolic Blood Pressure [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01352455 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pediatric End Stage Renal Disease
  • Hemodialysis
Procedure: Hemodialysis
5 days per week hemodialysis
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
Intervention: Procedure: Hemodialysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
September 2013
September 2013   (final data collection date for primary outcome measure)

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.

Both
3 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01352455
2010-0596
No
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
  • Children's Hospital Medical Center, Cincinnati
  • The Hospital for Sick Children
Principal Investigator: Benjamin L Laskin, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP