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NCT Number: NCT01352455

More Frequent In-Center Hemodialysis 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.

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Key information

Conditions

Pediatric End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodialysis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children, Toronto, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hemodialysis

Procedure

5 days per week hemodialysis

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: up to 24 weeks

Secondary outcomes

  1. Diastolic Blood Pressure

    Time frame: up to 24 weeks

  2. Treatment Costs

    Time frame: up to 24 weeks

  3. Quality of Life

    Time frame: up to 24 weeks

  4. Adverse Events/Symptoms

    Time frame: up to 24 weeks

  5. Bone Health

    Time frame: up to 24 weeks

  6. Anemia

    Time frame: up to 24 weeks

  7. Nutrition and Growth

    Time frame: up to 24 weeks

  8. Echocardiogram measured left ventricular mass

    Time frame: every 3 months

  9. School Performance

    Time frame: every 3 months

  10. Inflammatory Markers

    Time frame: every 3 months

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati
  • The Hospital for Sick Children

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 11, 2011
Registry last updated
Dec 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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