Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1,846 enrolled

Overview

OBJECTIVES: I. Evaluate whether hemodialysis providing a 2-pool, variable volume urea kinetic modelling value of 1.05 versus 1.45 reduces mortality and morbidity in patients with end stage renal disease. II. Compare the efficacy of high versus low flux dialyzer membranes.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, and diabetes prior to dialysis initiation. Patients are randomly assigned to 1 of 4 groups: moderate dose dialysis, low flux membrane; high dose dialysis, low flux membrane; moderate dose dialysis, high flux membrane; or high dose dialysis, high flux membrane. Moderate dose is a target eKt/V of 1.05 and high dose is 1.45. The dose and delivery of dialysis are measured monthly by the equilibrated fractional clearance of urea (eKt/V) calculated with double pool kinetics. Patients are dialyzed 3 times a week in the shortest possible time (minimum 2.5 hours), adjusted for adequate fluid removal. General medical care, protein and calorie intake, and dialyzer reuse and other aspects of dialysis therapy are standardized. The protocol document lists approved dialyzers; no unsubstituted cellulosic membranes are permitted. The intervention phase of this study is 5 years. Patients are followed for survival.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,846

Conditions

End Stage Renal Disease

Interventions

Standard dose, low flux hemodialysisDEVICE

Standard dose, high flux hemodialysisDEVICE

High dose, low flux hemodialysisDEVICE

High dose, high flux hemodialysis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * End stage renal disease that requires in-center hemodialysis 3 times/week On hemodialysis for at least 3 months (6 months following renal transplant) * No scheduled renal transplant from living donor --Prior/Concurrent Therapy-- * No concurrent intervention studies unless ancillary to this protocol No concurrent investigational drugs --Patient Characteristics-- * Hepatic: Albumin at least 2.6 g/dL by nephelometry No cirrhosis with encephalopathy or abnormal PT * Renal: Urea clearance (interdialytic) no greater than 1.5 mL/min per 35 liters total urea volume * Cardiovascular: No New York Heart Association class IV congestive heart failure despite maximal therapy No unstable angina No new onset angina No recent exacerbation of frequency, duration, or severity of angina * Pulmonary: No chronic pulmonary disease requiring supplemental oxygen * Other: Not hospitalized in acute or long term care facility at entry No active malignancy requiring chemotherapy or radiotherapy No AIDS No active systemic infection, e.g., tuberculosis or fungal infection No mental incompetence or other contraindication to protocol therapy Not pregnant Geographically available for treatment at participating institution No more than 20 missed treatments/year

Locations (1)

University of Rochester School of Medicine

Rochester, New York, United States

Outcomes

Primary Outcomes

Death from any cause

Time frame: 5 years

Secondary Outcomes

First hospitalization for cardiac causes or death from any cause

Time frame: 5 years

First hospitalization for infection or death from any cause

Time frame: 5 years

First >15% decrease in albumin or death from any cause

Time frame: 5 years

All hospitalizations not related to vascular access

Time frame: 5 years

Death due to cardiac causes

Time frame: 5 years

First hospitalization or death due to cardiac causes

Time frame: 5 years

Death due to infection

Time frame: 5 years

First hospitalization or death due to infection

Time frame: 5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.