Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis

Not Applicable

Completed

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 in terms of their blood pressure and weight. The researchers believe that maintaining patients at their estimated target weight throughout the week using daily ultrafiltration will reduce their blood pressure to levels shown in other similar studies. Such a reduction in blood pressure may reduce the incidence of cerebral vascular disease, peripheral vascular disease, coronary artery disease, and congestive heart failure. The researchers also believe that patients' quality of life will improve while they are undergoing daily ultrafiltration.

Studies show that more frequent dialysis treatments result in fewer symptoms for patients. The patients feel better and avoid the weight gains and symptoms that patients have on three times a week dialysis. In addition, their blood lab results are better controlled, requiring less medication.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Daily ultrafiltration	Ultrafiltration	During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.

Primary Outcome Measures

Name	Time	Method
Mean Arterial Blood Pressure	Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)

Secondary Outcome Measures

Name	Time	Method

Locations (3): Irving Place Dialysis Center
🇺🇸
New York, New York, United States
Upper Manhattan Dialysis Center
🇺🇸
New York, New York, United States
Yorkville Dialysis Center
🇺🇸
New York, New York, United States