Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis (HEMO)
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|ClinicalTrials.gov Identifier: NCT00004285|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : September 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Device: Standard dose, low flux hemodialysis Device: Standard dose, high flux hemodialysis Device: High dose, low flux hemodialysis Device: High dose, high flux hemodialysis||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||1846 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Study of Standard vs High Amount of Hemodialysis Using Low vs High Flux Dialyzer Membranes for End Stage Renal Disease|
|Actual Study Start Date :||March 1995|
|Actual Primary Completion Date :||December 31, 2001|
|Actual Study Completion Date :||December 31, 2001|
|Active Comparator: Standard dose, low flux hemodialysis||Device: Standard dose, low flux hemodialysis|
|Experimental: Standard dose, high flux hemodialysis||Device: Standard dose, high flux hemodialysis|
|Experimental: High dose, low flux hemodialysis||Device: High dose, low flux hemodialysis|
|Experimental: High dose, high flux hemodialysis||Device: High dose, high flux hemodialysis|
- Death from any cause [ Time Frame: 5 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004285
|United States, New York|
|University of Rochester School of Medicine|
|Rochester, New York, United States, 14642|
|Study Chair:||Daniel B. Ornt||University of Rochester|