Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis

NCT ID: NCT00825318

Last Updated: 2014-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Daily ultrafiltration

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

Group Type: EXPERIMENTAL

Ultrafiltration

Intervention Type: PROCEDURE

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

Interventions

Ultrafiltration

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vizio Medical Devices

UNKNOWN

Sponsor Role: collaborator

Renal Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan W Levin, MD

Role: PRINCIPAL_INVESTIGATOR

Renal Research Institute

Locations

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

Countries

United States

References

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

Reference Type: RESULT

PMID: 3727139 (View on PubMed)

Other Identifiers

004-09

Identifier Type: -

Identifier Source: org_study_id