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Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis

Primary Purpose

End-stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrafiltration
Sponsored by
Renal Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring End-stage renal disease, Chronic kidney disease, Hemodialysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Irving Place Dialysis Center
  • Upper Manhattan Dialysis Center
  • Yorkville Dialysis Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daily ultrafiltration

Arm Description

During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.

Outcomes

Primary Outcome Measures

Mean Arterial Blood Pressure

Secondary Outcome Measures

Full Information

First Posted
January 16, 2009
Last Updated
April 28, 2014
Sponsor
Renal Research Institute
Collaborators
Vizio Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00825318
Brief Title
Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renal Research Institute
Collaborators
Vizio Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
End-stage renal disease, Chronic kidney disease, Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily ultrafiltration
Arm Type
Experimental
Arm Description
During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
Intervention Type
Procedure
Intervention Name(s)
Ultrafiltration
Intervention Description
Frequency of ultrafiltration is increased from the conventional 3 times a week to 6 times a week.
Primary Outcome Measure Information:
Title
Mean Arterial Blood Pressure
Time Frame
Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan W Levin, MD
Organizational Affiliation
Renal Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irving Place Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Upper Manhattan Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Yorkville Dialysis Center
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3727139
Citation
Bytzer P. [Laxative abuse]. Ugeskr Laeger. 1986 Jun 2;148(23):1387-9. No abstract available. Danish.
Results Reference
result

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Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis

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