Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis
NCT ID: NCT00004285
Last Updated: 2017-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1846 participants
INTERVENTIONAL
1995-03-31
2001-12-31
Brief Summary
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II. Compare the efficacy of high versus low flux dialyzer membranes.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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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
High dose, high flux hemodialysis
High dose, high flux hemodialysis
Interventions
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Standard dose, low flux hemodialysis
Standard dose, high flux hemodialysis
High dose, low flux hemodialysis
High dose, high flux hemodialysis
Eligibility Criteria
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Inclusion 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
18 Years
80 Years
ALL
No
Sponsors
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University of Rochester
OTHER
The Cleveland Clinic
OTHER
Tufts Medical Center
OTHER
Vanderbilt University
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
OTHER
Washington University School of Medicine
OTHER
University of Illinois at Chicago
OTHER
Main Line Health
OTHER
Emory University
OTHER
Duke University
OTHER
University of Texas Southwestern Medical Center
OTHER
Brigham and Women's Hospital
OTHER
Wake Forest University Health Sciences
OTHER
University of Utah
OTHER
University of California, Davis
OTHER
University of Alabama at Birmingham
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Daniel B. Ornt
Role: STUDY_CHAIR
University of Rochester
Locations
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University of Rochester School of Medicine
Rochester, New York, United States
Countries
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References
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Greene T, Beck GJ, Gassman JJ, Gotch FA, Kusek JW, Levey AS, Levin NW, Schulman G, Eknoyan G. Design and statistical issues of the hemodialysis (HEMO) study. Control Clin Trials. 2000 Oct;21(5):502-25. doi: 10.1016/s0197-2456(00)00062-3.
Eknoyan G, Beck GJ, Cheung AK, Daugirdas JT, Greene T, Kusek JW, Allon M, Bailey J, Delmez JA, Depner TA, Dwyer JT, Levey AS, Levin NW, Milford E, Ornt DB, Rocco MV, Schulman G, Schwab SJ, Teehan BP, Toto R; Hemodialysis (HEMO) Study Group. Effect of dialysis dose and membrane flux in maintenance hemodialysis. N Engl J Med. 2002 Dec 19;347(25):2010-9. doi: 10.1056/NEJMoa021583.
Other Identifiers
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199/11704
Identifier Type: -
Identifier Source: org_study_id
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