Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Device: High dose, high flux hemodialysis; Device: Standard dose, low flux hemodialysis; Device: Standard dose, high flux hemodialysis; Device: High dose, low flux hemodialysis

• Registration Number: NCT00004285
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 1995-03
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Primary Completion: 2001-12-31
• Study Completion: 2001-12-31
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1846

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
High dose, high flux hemodialysis	High dose, high flux hemodialysis	-
Standard dose, low flux hemodialysis	Standard dose, low flux hemodialysis	-
Standard dose, high flux hemodialysis	Standard dose, high flux hemodialysis	-
High dose, low flux hemodialysis	High dose, low flux hemodialysis	-

Primary Outcome Measures

Name	Time	Method
Death from any cause	5 years

Secondary Outcome Measures

Name	Time	Method
First hospitalization for cardiac causes or death from any cause	5 years
First hospitalization for infection or death from any cause	5 years
First >15% decrease in albumin or death from any cause	5 years
All hospitalizations not related to vascular access	5 years
Death due to cardiac causes	5 years
First hospitalization or death due to cardiac causes	5 years
Death due to infection	5 years
First hospitalization or death due to infection	5 years

Trial Locations

Locations (1)

University of Rochester School of Medicine; 🇺🇸 Rochester, New York, United States