Edward Constantini

Mortality risks of peritoneal dialysis and hemodialysis

Studies of outcomes associated with dialysis therapies have yielded conflicting results. Bloembergen et al showed that prevalent patients on continuous ambulatory peritoneal dialysis (CAPD) or continuous cycling peritoneal dialysis (CCPD) had a 19% higher mortality risk than hemodialysis patients, and Fenton et al, analyzing Canadian incident patients, found a 27% lower risk. Attempting to reconcile these differences, we evaluated incident Medicare patients (99,048 on hemodialysis, 18,110 on CAPD/CCPD) from 1994 through 1996, following up to June 30, 1997. Patients were followed to transplantation, death, loss to follow-up, 60 days after modality change, or end of the study period. For each 3-month survival period, we used an interval Poisson regression to compare death rates, adjusting for age, gender, race, and primary renal diagnosis. A Cox regression was used to evaluate cause-specific mortality, and proportionality was addressed in both regressions by separating diabetic and nondiabetic patients. The Poisson regressions showed CAPD/CCPD to have outcomes comparable with or significantly better than hemodialysis, although results varied over time. The Cox regression found a lower mortality risk in nondiabetic CAPD/CCPD patients (women younger than 55 years: risk ratio [RR] = 0. 61; Cl, 0.59 to 0.66; women age 55 years or older: RR = 0.87; Cl, 0. 84 to 0.91; men younger than 55 years: RR = 0.72; Cl, 0.67 to 0.77; men age 55 years or older: RR = 0.87; Cl, 0.83 to 0.92) and in diabetic CAPD/CCPD patients younger than 55 (women: RR = 0.88; Cl, 0. 82 to 0.94; men: RR = 0.86; Cl, 0.81 to 0.92). The risk of all-cause death for female diabetics 55 years of age and older, in contrast, was 1.21 (Cl, 1.17 to 1.24) for CAPD/CCPD, and in cause-specific analyses, these patients had a significantly higher risk of infectious death. We conclude that, overall, within the first 2 years of therapy, short-term CAPD/CCPD appears to be associated with superior outcomes compared with hemodialysis. It also appears that patients on the two therapies have different mortality patterns over time, a nonproportionality that makes survival analyses vulnerable to the length of follow-up. Further investigation is needed to evaluate both the potential explanations for these findings and the use of more advanced statistical methods in the analysis of mortality rates associated with these dialytic therapies.

Excerpts From the US Renal Data System 2009 Annual Data Report

This 21st US Renal Data System Annual Data Report covers data through 2007, and again includes a section on chronic kidney disease (CKD) in the United States. Using NHANES and employer group health plan data, we estimate the relationship between kidney disease markers and mortality risk and the likelihood of blood pressure and lipid control by CKD stage; illustrate use of the new ICD-9-CM CKD diagnosis codes; and report on morbidity, mortality, care and costs during the transition to ESRD. New chapters address CKD patient care, the transition to ESRD, and acute kidney injury. In 2007, 111,000 patients started end-stage renal disease (ESRD) therapy, and the prevalent population reached 527,283 (including 368,544 dialysis patients); 17,513 transplants were performed, and 158,739 patients had a functioning graft at year’s end. Program expenditures reached

United States Renal Data System 2008 Annual Data Report Abstract

35.3 billion, with

Peer Kidney Care Initiative 2014 Report: Dialysis Care and Outcomes in the United States

23.9 billion from Medicare (accounting for 5.8% of total Medicare expenditures). The incident rate fell 2.1%, to 354 per million. Fistula use in prevalent patients declined 2.6 percent; catheter use continues to be a concern. The percentage of patients with hemoglobin levels above 13 g/dl has fallen since 2006, but levels in the incident population frequently exceed 12. First-year mortality and morbidity among hemodialysis patients—particularly the increasing rate of hospitalizations due to infections—continue to be major concerns, and pediatric patient survival has not improved. The public health impact of kidney disease is larger than previously appreciated, and early detection, education, intervention, and risk factor control need to address the heavy burden of cardiovascular disease and adverse events in this vulnerable population.

Impact of disease severity and hematocrit level on reuse-associated mortality.

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Liquid chromatographic analysis of di(2-ethylhexyl) phthalate: application to pharmacokinetic studies in the mongrel dog.

Eric Weinhandl, MS, Edward Constantini, MA, Susan Everson, PhD, David Gilbertson, PhD, Suying Li, PhD, Craig Solid, PhD, Michael Anger, MD, J. Ganesh Bhat, MD, Peter DeOreo, MD, Mahesh Krishnan, MD, Allen Nissenson, MD, Doug Johnson, MD, T. Alp Ikizler, MD, Franklin Maddux, MD, John Sadler, MD, Leanna Tyshler, MD, Tom Parker III, MD, Brigitte Schiller, MD, Barry Smith, MD, PhD, Stan Lindenfeld, MD, and Allan J. Collins, MD

US renal data system 2013 annual data report

Prior studies on reuse-associated mortality have presented conflicting results and included few adjustments for disease severity or hematocrit levels. To evaluate the impact of patient and provider characteristics on reuse-associated mortality, we developed a period-prevalent model with a 6-month entry period. Five cohorts of Medicare hemodialysis patients surviving from July 1 through December 31 of the entry year (1991, 60,985 patients; 1992, 63,081 patients; 1993, 76,018 patients; 1994, 82,899 patients; 1995, 91,761 patients) were followed up for the next year. Using a basic Cox regression survival model (M-1) including age, sex, race, renal diagnosis, prior end-stage renal disease time, unit age, unit size, water treatment, dialysate, and germicide, results were compared with those using a more inclusive model (M-4) adding dialyzer type (conventional or high efficiency/high flux), unit designation (hospital based or freestanding), unit profit status, comorbidity, disease severity, and hematocrit. The previous association of for-profit units with increased mortality was not present after 1994. Whereas the M-1 analysis showed better survival in reuse units after 1991, the more complete M-4 analysis showed no difference in the risk for mortality between reuse and no-reuse units. We conclude that mortality rates in the United States from 1991 to 1995, when adjusted comprehensively for patient and unit characteristics, were not different in units that practiced reuse and those that did not.

Excerpts from the United States Renal Data System 2007 annual data report.

A high-performance liquid chromatographic (HPLC) assay was developed for the determination of di(2-ethylhexyl) phthalate (DEHP) in serum or plasma. Plasma DEHP concentrations that were measured by HPLC in specimens obtained from hemodialysis patients were in good agreement with corresponding concentrations that were measured by gas chromatography with selected ion monitoring (GC-SIM) (r2 = 0.996). Plasma DEHP concentrations were measured after intravenous DEHP administration (1.2–4.4 mg DEHP/kg body weight) to determine the effect of bilateral ureteral ligation on DEHP elimination in the mongrel dog. DEHP plasma clearance (∼6.3 ml/min/kg), steady-state distribution volume (∼0.2l/kg), and terminal half-life (∼50 min) were unchanged in two dogs following bilateral ureteral ligation. DEHP terminal half-life and steady-state distribution volume were substantially smaller (25- to 70-fold) than reported previously in the rat or dog.