Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis

NCT00825318 | Completed Results

• 1 other identifier: 004-09
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

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.

Conditions

End-stage Renal Disease

Keywords

End-stage renal disease; Chronic kidney disease; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Mean Arterial Blood Pressure

  Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)

Study Arms (1)

Daily ultrafiltration

EXPERIMENTAL

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

Procedure: Ultrafiltration

Interventions

Ultrafiltration PROCEDURE

Frequency of ultrafiltration is increased from the conventional 3 times a week to 6 times a week.

Daily ultrafiltration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Renal Research Institute: lead
• Vizio Medical Devices: collaborator

Study Sites (3)

Irving Place Dialysis Center

New York, New York, 10003, United States

Location

Upper Manhattan Dialysis Center

New York, New York, 10025, United States

Location

Yorkville Dialysis Center

New York, New York, 10128, United States

Location

Related Publications (1)

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

  PMID: 3727139 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Interventions

Ultrafiltration

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena

Results Point of Contact

• Title: James Jones, MD
• Organization: St. Luke's-Roosevelt Hospital Center

JaJones@chpnet.org

2125233530

Study Officials

• Nathan W Levin, MD

  Renal Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2009
• First Posted: January 21, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 26, 2014
• Results First Posted: May 26, 2014

Record last verified: 2014-04

Locations

US (3)