### 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 language | English (US) |
---|---|

Journal | ASAIO Journal |

Volume | 42 |

Issue number | 5 |

State | Published - Sep 1996 |

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### ASJC Scopus subject areas

- Biophysics
- Bioengineering

### Cite this

*ASAIO Journal*,

*42*(5).

**The incident patient cohort study design with uncontrolled dose : Substantial over-estimation of mortality as a function of peritoneal dialysis dose?** / Gotch, Frank A.; Gentile, Dominick E.; Keen, Marcia L.; Amerling, Richard; Folkert, Vaughn Wesley; Kliger, Alan S.; Shapiro, Warren B.

Research output: Contribution to journal › Article

*ASAIO Journal*, vol. 42, no. 5.

}

TY - JOUR

T1 - The incident patient cohort study design with uncontrolled dose

T2 - Substantial over-estimation of mortality as a function of peritoneal dialysis dose?

AU - Gotch, Frank A.

AU - Gentile, Dominick E.

AU - Keen, Marcia L.

AU - Amerling, Richard

AU - Folkert, Vaughn Wesley

AU - Kliger, Alan S.

AU - Shapiro, Warren B.

PY - 1996/9

Y1 - 1996/9

N2 - 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.

AB - 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.

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M3 - Article

VL - 42

JO - ASAIO journal (American Society for Artificial Internal Organs : 1992)

JF - ASAIO journal (American Society for Artificial Internal Organs : 1992)

SN - 1058-2916

IS - 5

ER -