article276

HEMO

"Dialysis Dose and the Effect of Membrane Flux in Maintenance Hemodialysis".The New England Journal of Medicine. 2002. 347(25):2010-2019.PubMed•Full text•PDF

1 Clinical Question
2 Bottom Line
3 Major Points
4 Guidelines
5 Design
6 Population
6.1 Inclusion Criteria
6.2 Exclusion Criteria
6.3 Baseline Characteristics
7 Interventions
8 Outcomes
8.1 Primary Outcome
8.2 Secondary Outcomes
9 Funding
10 Further Reading

Clinical Question

Among patients undergoing maintenance hemodialysis, does increasing the dose of dialysis or using a high-flux dialyzer membrane improve survival or reduce morbidity?

Bottom Line

Among patients undergoing maintenance hemodialysis, neither increased dose of dialysis beyond the current U.S. recommended levels nor the use of high-flux membranes substantially improves survival or reduces morbidity when compared to a standard dose and low-flux membranes.

Major Points

Guidelines

Current U.S. practice guidelines recommend a single-pool Kt/V of at least 1.24 but do not specifically recommend for or against the routine use of high-flux membranes.

Design

Multicenter, double-blind, randomized, two-by-two factorial clinical trial
N=1,846 patients undergoing thrice-weekly in-center hemodialysis
Intervention groups:
Standard dose of dialysis (equilibrated Kt/V ~1.16) vs. high dose of dialysis (equilibrated Kt/V ~1.53)
Low-flux dialyzer (beta2-microglobulin clearance ~3 mL/min) vs. high-flux dialyzer (beta2-microglobulin clearance ~34 mL/min)

Population

Inclusion Criteria: Patients aged 18 to 80 undergoing thrice-weekly in-center hemodialysis for ≥3 months
Exclusion Criteria: Serum albumin <2.6 g/dL, residual urea clearance >1.5 mL/min per 35 liters or inability to achieve equilibrated Kt/V >1.30 within 4.5 hours in test runs
Baseline Characteristics: Predominance of urban centers; high rates of hypertension (96%), diabetes (45%), and cardiac disease (80%)

Interventions

Randomized 1:1 ratio to either a standard-dose or high-dose goal and to dialysis with either a low-flux or high-flux dialyzer.

Outcomes

Primary Outcome:
Death from any cause: no significant difference between dose groups (RR 0.96, 95% CI 0.84 to 1.10, P=0.53) or between flux groups (RR 0.92, 95% CI 0.81 to 1.05, P=0.23)
Secondary Outcomes:
Hospitalizations for cardiac causes or death, hospitalizations for infection or death, decline in serum albumin levels or death, and hospitalizations not related to vascular access: no significant difference between dose or flux groups
Possible benefits of dose or flux interventions suggested in subgroups of patients

Funding

Supported by the National Institute of Diabetes and Digestive and Kidney Diseases with additional support from Baxter Healthcare, Fresenius Medical Care, R&D Laboratories, and Ross Laboratories.