Comparison Study of Daily Ultrafiltration and Twice-weekly 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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Irving Place Dialysis Center, New York, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrafiltration

Procedure

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

Primary outcomes

Mean Arterial Blood Pressure

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

Sponsors and collaborators

Lead sponsor

Renal Research Institute

Other

Collaborators

Vizio Medical Devices

Registry information

Official study 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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jan 21, 2009
Registry last updated: May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed