Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis (HEMO)

National Institutes of Health (NIH)

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Device: High dose, low flux hemodialysis; Device: Standard dose, low flux hemodialysis; Device: Standard dose, high flux hemodialysis; Device: High dose, high flux hemodialysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004285

U01DK049261 (U.S. NIH Grant/Contract)

U01DK049243 (U.S. NIH Grant/Contract)

U01DK049254 (U.S. NIH Grant/Contract)

199/11704

U01DK046114 (U.S. NIH Grant/Contract)

U01DK049242 (U.S. NIH Grant/Contract)

U01DK046109 (U.S. NIH Grant/Contract)

U01DK049264 (U.S. NIH Grant/Contract)

U01DK049241 (U.S. NIH Grant/Contract)

U01DK049259 (U.S. NIH Grant/Contract)

U01DK049249 (U.S. NIH Grant/Contract)

U01DK046140 (U.S. NIH Grant/Contract)

U01DK049252 (U.S. NIH Grant/Contract)

U01DK049244 (U.S. NIH Grant/Contract)

U01DK049271 (U.S. NIH Grant/Contract)

U01DK046126 (U.S. NIH Grant/Contract)

U01DK046143 (U.S. NIH Grant/Contract)

U01DK049240 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,846 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,846 participants in 4 patient groups

Standard dose, low flux hemodialysis

Active Comparator group

Treatment:

Device: Standard dose, low flux hemodialysis

Standard dose, high flux hemodialysis

Experimental group

Treatment:

Device: Standard dose, high flux hemodialysis

High dose, low flux hemodialysis

Experimental group

Treatment:

Device: High dose, low flux hemodialysis

High dose, high flux hemodialysis

Experimental group

Treatment:

Device: High dose, high flux hemodialysis