The incident patient cohort study design with uncontrolled dose: Substantial over-estimation of mortality as a function of peritoneal dialysis dose?

Frank A. Gotch, Dominick E. Gentile, Marcia L. Keen, Richard Amerling, Vaughn W. Folkert, Alan S. Kliger, Warren B. Shapiro

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Abstract

In the Canada-USA (CANUSA) Study, the dialysis dose was neither randomized nor held constant, was measured at 6 month intervals, and the relative risk of mortality (R) was found to correlate linearly to mean values of weekly peritoneal plus renal urea clearance normalized to volume, (KprT/V)m, ranging from 1.5 to 2.3. A risk/dose (R/D) function was derived for continuous ambulatory peritoneal dialysis from kinetic criteria for dose equivalency in hemodialysis (HD) and peritoneal dialysis (PD) and the HD R/D function. This PD R/D function was nonlinear with breakpoint from steep to shallow slope at (KprT/V)ud = 2.00, where ud refers to uniform single doses in contrast to mean doses with wide variances on the mean. The predicted decrease in renal urea clearance KrT/V per 6 months of CANUSA follow-up was computed from serial measured KrT/V in the Randomized Dialysis Prescription and Clinical Outcomes Study and showed it to be 0.21 ± 0.34. The CANUSA (KprT/V)m values were corrected for the distributed values of 3 month decrements in KrT/V, and the population mortality risk at each (KprT/V)m dose level reported in CANUSA was computed from summation of the product of the R/D curve and fractional distribution of (KprT/V)ud values. From these calculations, the authors conclude that maximum (KprT/V)ud level achieved in CANUSA was 2.00, and the study does not define R/D response above this level.

Original languageEnglish (US)
Pages (from-to)M514-M517
JournalASAIO Journal
Volume42
Issue number5
StatePublished - Sep 1 1996

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ASJC Scopus subject areas

  • Biophysics
  • Bioengineering
  • Biomaterials
  • Biomedical Engineering

Cite this

Gotch, F. A., Gentile, D. E., Keen, M. L., Amerling, R., Folkert, V. W., Kliger, A. S., & Shapiro, W. B. (1996). The incident patient cohort study design with uncontrolled dose: Substantial over-estimation of mortality as a function of peritoneal dialysis dose? ASAIO Journal, 42(5), M514-M517.