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Randomized Controlled Trial
. 2009 Mar;20(3):645-54.
doi: 10.1681/ASN.2008060590. Epub 2008 Dec 17.

Effect of membrane permeability on survival of hemodialysis patients

Collaborators, Affiliations
Randomized Controlled Trial

Effect of membrane permeability on survival of hemodialysis patients

Francesco Locatelli et al. J Am Soc Nephrol. 2009 Mar.

Abstract

The effect of high-flux hemodialysis membranes on patient survival has not been unequivocally determined. In this prospective, randomized clinical trial, we enrolled 738 incident hemodialysis patients, stratified them by serum albumin < or = 4 and >4 g/dl, and assigned them to either low-flux or high-flux membranes. We followed patients for 3 to 7.5 yr. Kaplan-Meier survival analysis showed no significant difference between high-flux and low-flux membranes, and a Cox proportional hazards model concurred. Patients with serum albumin < or = 4 g/dl had significantly higher survival rates in the high-flux group compared with the low-flux group (P = 0.032). In addition, a secondary analysis revealed that high-flux membranes may significantly improve survival of patients with diabetes. Among those with serum albumin < or = 4 g/dl, slightly different effects among patients with and without diabetes suggested a potential interaction between diabetes status and low serum albumin in the reduction of risk conferred by high-flux membranes. In summary, we did not detect a significant survival benefit with either high-flux or low-flux membranes in the population overall, but the use of high-flux membranes conferred a significant survival benefit among patients with serum albumin < or = 4 g/dl. The apparent survival benefit among patients who have diabetes and are treated with high-flux membranes requires confirmation given the post hoc nature of our analysis.

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Figures

Figure 1.
Figure 1.
Number of patients enrolled in the study, allocated to the strata of serum albumin, randomized to the study groups, and included in the analysis populations. Patients not included in the survival analysis population: A, no study treatment started; B, major protocol violations at enrollment; C, premature termination or death before month 0; D, Kt/V <1.2 (end of run-in phase or month 3).
Figure 2.
Figure 2.
Kaplan-Meier survival curves for the complete intention-to-treat population (Log-rank test P = 0.214).
Figure 3.
Figure 3.
Kaplan-Meier survival curves for the population of patients with serum albumin ≤4 g/dl (Log-rank test P = 0.032).
Figure 4.
Figure 4.
Kaplan-Meier survival curves for the subpopulation of patients with diabetes (Log-rank test P = 0.039).

Comment in

References

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