More Frequent In-Center Hemodialysis in Pediatric End Stage Renal Disease
This study is currently recruiting participants.
Verified May 2011 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Children's Hospital Medical Center, Cincinnati
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01352455
First received: May 9, 2011
Last updated: May 10, 2011
Last verified: May 2011
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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 Medical Center, Cincinnati:
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 ]
| Estimated Enrollment: | 10 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | June 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352455
Contacts
| Contact: Benjamin L Laskin, MD | 513-636-4531 | benjamin.laskin@cchmc.org |
| Contact: Mark Mitsnefes, MD | 513-636-4531 | mark.mitsnefes@cchmc.org |
Locations
| United States, Ohio | |
| Cincinnati Childrens Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Benjamin L Laskin, MD 513-636-4531 | |
| Contact: Mark Mitsnefes, MD 513-636-4531 | |
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
| Principal Investigator: | Benjamin L Laskin, MD | Children's Hospital Medical Center, Cincinnati |
More Information
No publications provided
| Responsible Party: | Benjamin Laskin, MD, Cincinnati Children's Hospital Medical Center |
| ClinicalTrials.gov Identifier: | NCT01352455 History of Changes |
| Other Study ID Numbers: | 2010-0596 |
| Study First Received: | May 9, 2011 |
| Last Updated: | May 10, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
|
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 May 16, 2013