Status:
COMPLETED
Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis
Lead Sponsor:
Renal Research Institute
Collaborating Sponsors:
Vizio Medical Devices
Conditions:
End-stage Renal Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
In this study, the researchers want to find out how patients who have ultrafiltration (removal of excess fluid) 6 times a week and twice-weekly dialysis (removal of excess fluid and waste products) do...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years and less than or equal to 80 years
- Stable three treatments per week dialysis schedule for at least three months prior to beginning the study
- Residual renal clearance \<1.5ml/min per 35L of urea volume
- Pre-dialysis serum sodium levels of greater than 136 mEq/L
Exclusion
- Non-compliance with hemodialysis treatments--defined as missing more than 1 treatment over the 3 month period prior to the study
- Unable to verbally communicate in English or Spanish
- Current requirement for hemodialysis more than three times per week due to medical comorbidity (including fourth session for ultrafiltration)
- Currently on daily or nocturnal hemodialysis, or less than 3 months since discontinued such treatment
- Expected geographic unavailability at dialysis center during any phase of the trial
- Less than 3 months since the patient returned after acute rejection resulting in allograft failure
- Currently in acute care or chronic care hospital
- Pregnancy
- Current involvement in any non-observational trial
- Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
- Unable or unwilling to provide informed consent or sign IRB-approved consent form
- Pace maker, implantable pump, artificial joint
- Amputation of a limb
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00825318
Start Date
July 1 2009
End Date
December 1 2011
Last Update
May 26 2014
Active Locations (3)
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1
Irving Place Dialysis Center
New York, New York, United States, 10003
2
Upper Manhattan Dialysis Center
New York, New York, United States, 10025
3
Yorkville Dialysis Center
New York, New York, United States, 10128