Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

Palo Alto Veterans Institute for Research58 enrolled

Overview

The study will determine the efficacy of twice weekly hemodialysis in patients with residual kidney function.

Hemodialysis patients who have residual kidney function will undergo two 4-week study (twice weekly versus thrice weekly hemodialysis) using a cross-over design. Blood, urine, and dialysate samples will be collected at the end of each study period to determine adequacy of treatment and to assess uremic solute levels. Participants will complete quality of life questionnaires and cognitive paper tests.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hemodialysis Kidney Failure, Chronic

Interventions

Twice Weekly Hemodialysis then Thrice Weekly HemodialysisOTHER

Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.

Thrice Weekly Hemodialysis then Twice Weekly HemodialysisOTHER

Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients on hemodialysis who have residual kidney function with residual urea clearance (Kru) \>2.5 mL/min. * been on hemodialysis for at least 3 months. * adherence to regular dialysis treatments. Exclusion Criteria: * inability to achieve adequate hemodialysis. * planned revision of hemodialysis vascular access. * hospitalized within the past 2 months.

Locations (3)

VA Palo Alto Health Care System

Palo Alto, California, United States

Santa Clara Valley Medical Center

San Jose, California, United States

Satellite HealthCare

San Jose, California, United States

Outcomes

Primary Outcomes

QOL: Kidney Disease Quality of Life (KDQOL36)

Kidney Disease Quality of Life: Health-related quality of life, with higher scores being better. Minimum is 0, maximum is 100.

Time frame: 4 weeks

Secondary Outcomes

Solute Concentration

Plasma concentration of p-cresol sulfate

Time frame: 4 weeks

Symptom

Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.

Time frame: 4 weeks

Trail B Making Test

Cognitive test: The Trail B Making Test assesses working memory, cognitive flexibility, processing speed, and visual-motor tracking. There are numbers and letters on a page. The participant must connect the number to letter in order. For example, they would start at 1 and draw a line to A, then draw a line to 2, then draw a line to B, then draw a line to 3. The time is recorded in seconds.

Time frame: 4 weeks

Digit Symbol Substitution Test

Cognitive test: Digit Symbol Substitution Test, measured in number correct

Time frame: 4 weeks

Data from ClinicalTrials.gov

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