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

Primary Purpose

Pediatric End Stage Renal Disease, Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Hemodialysis
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pediatric End Stage Renal Disease focused on measuring Hemodialysis, Pediatric, Outcomes, Comparative Effectiveness, End Stage Renal Disease

Eligibility Criteria

3 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cincinnati Childrens Hospital Medical Center
  • Children's Hospital of Philadelphia
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

5 days per week hemodialysis

Arm Description

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

Outcomes

Primary Outcome Measures

Systolic Blood Pressure

Secondary Outcome Measures

Diastolic Blood Pressure
Treatment Costs
Quality of Life
Adverse Events/Symptoms
Bone Health
Anemia
Nutrition and Growth
Echocardiogram measured left ventricular mass
School Performance
Inflammatory Markers

Full Information

First Posted
May 9, 2011
Last Updated
December 27, 2013
Sponsor
Children's Hospital of Philadelphia
Collaborators
Children's Hospital Medical Center, Cincinnati, The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT01352455
Brief Title
More Frequent In-Center Hemodialysis in Pediatric End Stage Renal Disease
Official Title
A Pilot Study of More Frequent In-Center Hemodialysis to Improve Outcomes in Pediatric End Stage Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Children's Hospital Medical Center, Cincinnati, The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric End Stage Renal Disease, Hemodialysis
Keywords
Hemodialysis, Pediatric, Outcomes, Comparative Effectiveness, End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 days per week hemodialysis
Arm Type
Experimental
Arm Description
5 days per week, 2 hours 20 minutes per session versus 3 days per week, 4 hours per session
Intervention Type
Procedure
Intervention Name(s)
Hemodialysis
Intervention Description
5 days per week hemodialysis
Primary Outcome Measure Information:
Title
Systolic Blood Pressure
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Diastolic Blood Pressure
Time Frame
up to 24 weeks
Title
Treatment Costs
Time Frame
up to 24 weeks
Title
Quality of Life
Time Frame
up to 24 weeks
Title
Adverse Events/Symptoms
Time Frame
up to 24 weeks
Title
Bone Health
Time Frame
up to 24 weeks
Title
Anemia
Time Frame
up to 24 weeks
Title
Nutrition and Growth
Time Frame
up to 24 weeks
Title
Echocardiogram measured left ventricular mass
Time Frame
every 3 months
Title
School Performance
Time Frame
every 3 months
Title
Inflammatory Markers
Time Frame
every 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin L Laskin, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Hospital for Sick Children
City
Toronto
Country
Canada

12. IPD Sharing Statement

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

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