Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis

Pilot Trial To Study Blood Pressure, Weight and Hydration State in Patients Undergoing A Treatment Regimen of Daily Ultrafiltration and Twice-weekly Hemodialysis As Compared to Conventional Three Times Per Week Hemodialysis

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.

Study Overview

• Status: Completed
• Conditions: End-stage Renal Disease
• Intervention / Treatment: Procedure: Ultrafiltration

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10128
      • Yorkville Dialysis Center
    • New York, New York, United States, 10003
      • Irving Place Dialysis Center
    • New York, New York, United States, 10025
      • Upper Manhattan Dialysis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daily ultrafiltration; During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.	Procedure: Ultrafiltration; Frequency of ultrafiltration is increased from the conventional 3 times a week to 6 times a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Arterial Blood Pressure	Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)

Collaborators and Investigators

• Sponsor: Renal Research Institute
• Collaborators: Vizio Medical Devices
• Investigators: Principal Investigator: Nathan W Levin, MD, Renal Research Institute

Publications and helpful links

General Publications

• Bytzer P. [Laxative abuse]. Ugeskr Laeger. 1986 Jun 2;148(23):1387-9. No abstract available. Danish.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: January 16, 2009
• First Submitted That Met QC Criteria: January 19, 2009
• First Posted (Estimate): January 21, 2009

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: April 28, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: End-stage renal disease; Chronic kidney disease; Hemodialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 004-09