The APOL1 gene and allograft survival after kidney transplantation.

Coding variants in the apolipoprotein L1 gene (APOL1) are strongly associated with nephropathy in African Americans (AAs). The effect of transplanting kidneys from AA donors with two APOL1 nephropathy risk variants is unknown. APOL1 risk variants were genotyped in 106 AA deceased organ donors and graft survival assessed in 136 resultant kidney transplants. Cox-proportional hazard models tested for association between time to graft failure and donor APOL1 genotypes. The mean follow-up was 26.4 ± 21.8 months. Twenty-two of 136 transplanted kidneys (16%) were from donors with two APOL1 nephropathy risk variants. Twenty-five grafts failed; eight (32%) had two APOL1 risk variants. A multivariate model accounting for donor APOL1 genotype, overall African ancestry, expanded criteria donation, recipient age and gender, HLA mismatch, CIT and PRA revealed that graft survival was significantly shorter in donor kidneys with two APOL1 risk variants (hazard ratio [HR] 3.84; p = 0.008) and higher HLA mismatch (HR 1.52; p = 0.03), but not for overall African ancestry excluding APOL1. Kidneys from AA deceased donors harboring two APOL1 risk variants failed more rapidly after renal transplantation than those with zero or one risk variants. If replicated, APOL1 genotyping could improve the donor selection process and maximize long-term renal allograft survival.

Frequent Hemodialysis Network (FHN) randomized trials: study design.

Observational studies suggest improvements with frequent hemodialysis (HD), but its true efficacy and safety remain uncertain. The Frequent Hemodialysis Network Trials Group is conducting two multicenter randomized trials of 250 subjects each, comparing conventional three times weekly HD with (1) in-center daily HD and (2) home nocturnal HD. Daily HD will be delivered for 1.5-2.75 h, 6 days/week, with target eK(t)/V(n) > or = 0.9/session, whereas nocturnal HD will be delivered for > or = 6 h, 6 nights/week, with target stdK(t)/V of > or = 4.0/week. Subjects will be followed for 1 year. The composite of mortality with the 12-month change in (i) left ventricular mass index (LVMI) by magnetic resonance imaging, and (ii) SF-36 RAND Physical Health Composite (PHC) are specified as co-primary outcomes. The seven main secondary outcomes are between group comparisons of: change in LVMI, change in PHC, change in Beck Depression Inventory score, change in Trail Making Test B score, change in pre-HD serum albumin, change in pre-HD serum phosphorus, and rates of non-access hospitalization or death. Changes in blood pressure and erythropoiesis will also be assessed. Safety outcomes will focus on vascular access complications and burden of treatment. Data will be obtained on the cost of delivering frequent HD compared to conventional HD. Efforts will be made to reduce bias, including blinding assessment of subjective outcomes. Because no large-scale randomized trials of frequent HD have been previously conducted, the first year has been designated a Vanguard Phase, during which feasibility of randomization, ability to deliver the interventions, and adherence will be evaluated.

Clinical performance measures: the changing status of peritoneal dialysis.

BACKGROUND: The Peritoneal Dialysis-Clinical Performance Measures Project (PD-CPM) characterizes peritoneal dialysis within the U.S. Current survey results are reported and compared to those of previous years. METHODS: Prevalence data from random national samples of adult peritoneal dialysis (PD) patients participating in the United States End-Stage Renal Disease (ESRD) program have been collected annually since 1995. RESULTS: In 1995, 79% of the respondents used continuous ambulatory peritoneal dialysis (CAPD) rather than automated peritoneal dialysis (APD). The mean hematocrit (Hct) of PD patients was 32% and only 66% of individuals had a measurement of dialysis adequacy reported. The mean weekly Kt/Vurea (wKt/V) and weekly creatinine clearance (wCCr) reported for CAPD patients in 1995 were 1.9 and 67 L/1.73 m2/week, respectively. In 2000 the median age of PD patients was 55 years and 63% were white. The leading cause of ESRD was diabetes mellitus (34%) and 54% of adult PD patients performed some form of APD rather than CAPD. Age, sex, size, hematocrit, peritoneal permeability, dialysis adequacy, residual renal function and nutritional indices did not differ between APD and CAPD patients. The mean hemoglobin (Hb) for the 2000 PD-CPM population was 11.6 +/- 1.4 g/dL (mean +/- 1 SD) and 11% of patients had an average Hb below 10 g/dL. The average serum albumin was 3.5 +/- 0.5 g/dL by the bromcresol green method and 56% of subjects had an average serum albumin equal to or above 3.5 g/dL (or 3.2 g/dL by bromcresol purple). In 2000 85% of patients had a dialysis adequacy measurement reported and the mean calculated wKt/V and wCCr were 2.3 +/- 0.6 and 72.7 +/- 24.9 liters/1.73 m2/week for CAPD patients and 2.3 +/- 0.6 and 71.6 +/- 25.1 L/1.73 m2/week for APD patients. PD subjects had a mean body weight of 76 +/- 19 kg and body mass index (BMI) of 27.5 +/- 6.4 kg/m2. The protein equivalent of nitrogen appearance (nPNA) of these patients was 0.95 +/- 0.31 g/kg/day, their normalized creatinine appearance rate (nCAR) equaled 17 +/- 6.5 mg/kg/day, resulting in a percent lean body mass (%LBM) of 64 +/- 17% of actual body weight. Serum albumin correlated in a positive fashion with BMI, nPNA, nCAR and %LBM, but not with wCCr. CONCLUSIONS: The majority of indicator variables monitored by the PD-CPM have improved since 1995. PD patients have higher hemoglobins and a greater proportion of patients meet the criteria for adequate dialysis. Serum albumin values, however, remain marginal and unchanged over the five-year project. Furthermore, serum albumin values fail to correlate with the intensity of renal replacement therapy and are not strongly correlated with alternative estimates of nutritional status.

Nutritional markers during peritoneal dialysis: data from the 1998 Peritoneal Dialysis Core Indicators Study.

OBJECTIVE: This analysis explores the nutritional status of adult U.S. peritoneal dialysis (PD) patients. DESIGN: The Peritoneal Dialysis Core Indicators Study is a prospective cross-sectional prevalence survey describing the care provided to a random sample of adult U.S. PD patients. METHODS AND POPULATION: Prevalence data were collected from a national random sample of 1381 adult PD patients participating in the United States End Stage Renal Disease (ESRD) program. RESULTS: The median age of these patients was 55 years, 61% were Caucasian; the leading cause of ESRD was diabetes mellitus. Age, sex, size, peritoneal permeability, dialysis adequacy, and nutritional indices did not differ between patients on continuous ambulatory PD and patients on automated PD. The dialysis prescriptions employed achieved mean weekly Kt/V urea (wKt/V) and creatinine clearance (wCCr) values of 2.22 +/- 0.57 and 67.8 +/- 22.5 L/1.73 m2/week, respectively. The PD patients were large, with a mean body weight of 77 +/- 21 kg and body mass index (BMI) of 27 +/- 8.6 kg/m2. The mean serum albumin of these patients was 3.5 +/- 0.51 g/dL, and 43% of values fell below the National Kidney Foundation Dialysis Outcomes Quality Initiative's desired range. The PD patients had a normalized protein equivalent of nitrogen appearance (nPNA) of 1.0 +/- 0.57 g/kg/day, a normalized creatinine appearance rate (nCAR) of 17 +/- 7.3 mg/kg/day, and an estimated lean body mass (%LBM) of 62% +/- 18% of body weight. Serum albumin correlated positively with patient size, nCAR, and nPNA, but negatively with age, the presence of diabetes mellitus, female gender, erythropoietin dose, the creatinine dialysate-to-plasma ratio results of peritoneal equilibration testing, and the dialysis portion of the wCCr. The duration of ESRD experience correlated negatively with both serum albumin and patient size, although these relationships were complex. CONCLUSION: Peritoneal dialysis patients generally have marginal serum albumin levels, a finding incongruent with alternative measures of nutritional status, such as weight, BMI, and creatinine generation. Serum albumin is reduced in patients with high peritoneal permeability (i.e., rapid transporters) and, because these patients generally have higher than average wCCr values, serum albumin is inversely correlated with the dialysis component of the wCCr. The presumptive nutritional indicators (BMI, %LBM, nPNA, and serum albumin) provide disparate estimates, varying from 10% to 50% for the prevalence of nutritionally stressed PD patients.

Duration of dialysis and its relationship to dialysis adequacy, anemia management, and serum albumin level.

An analysis of the relationship between intermediate outcomes and duration of dialysis therapy in hemodialysis patients was performed by linking Health Care Financing Administration (HCFA) Core Indicators data with data obtained from HCFA form 2728 at the initiation of dialysis therapy. Patients who recently initiated hemodialysis therapy were less likely to meet Dialysis Outcomes Quality Initiative guidelines than patients with a longer duration of dialysis therapy. For both urea reduction ratio and Kt/V, odds ratios for adequate dialysis were approximately 0.20 for a duration of dialysis therapy less than 0.5 years and 0.42 to 0.63 for a duration of dialysis therapy of 0.5 to 1.0 years compared with a duration of dialysis therapy of 2.0 years or greater. For patients with a duration of dialysis therapy less than 0.5 years (compared with >/=2.0 years), the odds ratio for a hematocrit less than 28% was approximately 3.0, that for a hematocrit 33% or greater was approximately 0.6, and that for a serum albumin level of 3.5 g/dL or greater (bromcresol green method) or 3.2 g/dL or greater (bromcresol purple method) was approximately 0.4. There was a direct relationship between glomerular filtration rate at the initiation of dialysis therapy and both serum albumin and hematocrit values. Patients administered recombinant human erythropoietin (rHuEPO) predialysis were more likely to have greater hematocrits. There also was a direct relationship between hematocrit and serum albumin level. Therefore, several actionable items in regard to attentive overall medical care can result in an improvement in the percentage of patients newly started on hemodialysis therapy who meet intermediate outcomes, including the administration of rHuEPO predialysis, correction of iron deficiency, and timely placement of a permanent dialysis access.

Risk factors for hypertension in chronic hemodialysis patients: baseline data from the HEMO study.

A cross-sectional analysis was performed to determine risk factors associated with hypertension in 1,238 chronic hemodialysis patients upon enrollment into the HEMO Study. The mean pre- and post-dialysis systolic blood pressure were 152.4 +/- 25.0 (mean +/- SD) and 137.8 +/- 24.6 mm Hg, respectively. The mean pre- and post-dialysis diastolic blood pressures were 82.1 +/- 14.8 and 74.7 +/- 13.8 mm Hg, respectively. Less than 30% of the study cohort had blood pressures that were normotensive by JNC VI guidelines. Risk factors associated with higher pre- and post-dialysis systolic blood pressures included the presence of diabetes mellitus, older age, increased number of prescribed antihypertensive medications, lower hematocrit, and absence of arrhythmias. Variables associated with higher pre- and post-dialysis diastolic blood pressures included younger age, increased number of prescribed anti-hypertensive medications and absence of arrhythmias. There was also a nonlinear relationship between blood pressure and prescribed total ultrafiltration volume. A total ultrafiltration volume of >2.5 kg was associated with an elevation in pre-dialysis systolic and diastolic blood pressures. A total ultrafiltration volume of < or =2.5 kg was associated with an elevation in post-dialysis systolic and diastolic blood pressures. These data on ultrafiltration volume suggest that higher pre-dialysis blood pressures may be associated with excessive interdialytic weight gains due to patient noncompliance with fluid restriction and that higher post-dialysis blood pressures may be associated with a prescribed dry weight that is higher than the patient's true dry weight. Better management of these parameters may improve the prevalence and severity of hypertension in this population.

Subcutaneous erythropoietin results in lower dose and equivalent hematocrit levels among adult hemodialysis patients: Results from the 1998 End-Stage Renal Disease Core Indicators Project.

The National Kidney Foundation's Dialysis Outcome Quality Initiative (NKF-DOQI) guidelines recommend that epoetin alfa should be administered by the subcutaneous route in hemodialysis patients. We determined whether hematocrit levels in hemodialysis patients differed by route of epoetin alfa administration after controlling for demographic factors and iron status. Data were available for 7,092 of the 7,658 patients randomly chosen for inclusion in the 1997 Health Care Financing Administration Core Indicators sample. Epoetin alfa was administered to 96% of the study cohort and was administered subcutaneously in 10% of patients. After controlling for hematocrit, patient characteristics, adequacy of dialysis, iron status, serum albumin, postdialysis weight, and duration of dialysis, the epoetin alfa dose by the intravenous route was 193.6 units/kg/wk (95% confidence interval, 189.5 to 197.8 units/kg/wk) compared with 167.4 units/kg/wk (95% confidence interval, 153.9 to 180.8 units/kg/wk) for the subcutaneous route (P < 0.001). The mean hematocrit for the subcutaneous route was 32.7% +/- 3.4% and for the intravenous route was 33.0% +/- 3.2% (P < 0.05). Factors independently associated with increased hematocrit included male gender, white race, older patient age, greater number of years on dialysis, higher serum albumin concentration, higher urea reduction ratio, and percent transferrin saturation (all P < 0.001). After controlling for patient factors and weekly epoetin alfa dose, there was no association between route of epoetin alfa administration and hematocrit level (P = 0.144). Patients receiving epoetin alfa by the subcutaneous route had comparable hematocrit values using a lower epoetin alfa dose than patients receiving epoetin alfa intravenously. These data support the NKF-DOQI recommendation that epoetin alfa be administered subcutaneously in long-term hemodialysis patients.

Impact of facility size and profit status on intermediate outcomes in chronic dialysis patients.

Little information is available regarding the influence of dialysis facility size or profit status on intermediate outcomes in chronic dialysis patients. We have combined data from the Health Care Financing Administration (HCFA) Core Indicators Project; the end-stage renal disease (ESRD) facility survey; and the HCFA On-Line Survey, Certification, and Reporting System to analyze trends in this area. For hemodialysis patients, larger facilities were more likely than smaller facilities to perform dialysis on patients who were younger than 65 years of age, black, or undergoing dialysis 2 years or more (P < 0.001). Nonprofit facilities were more likely to perform dialysis on patients with diabetes mellitus as a cause of ESRD and less likely to perform dialysis on patients with hypertension as a cause of ESRD compared with for-profit units (P < 0.05). By multivariate analysis, larger facility size was modestly associated with a greater Kt/V value and urea reduction ratio, but not with hematocrit or serum albumin values. Facility profit status was not associated with these intermediate outcomes. For peritoneal dialysis patients, there were no significant differences in patient demographics based on facility size. More patients in nonprofit units had been undergoing dialysis 2 or more years than patients in for-profit units (P < 0.05). By univariate analysis, patients in larger facilities were more likely to have an adequacy measure performed than patients from smaller facilities (P < 0.05). There were few substantial differences in intermediate outcomes in chronic dialysis patients based on facility size or profit status.

Atherosclerotic cardiovascular disease risks in chronic hemodialysis patients.

BACKGROUND: Cardiovascular diseases are the most common causes of death among chronic hemodialysis patients, yet the risk factors for these events have not been well established. METHODS: In this cross-sectional study, we examined the relationship between several traditional cardiovascular disease risk factors and the presence or history of cardiovascular events in 936 hemodialysis patients enrolled in the baseline phase of the Hemodialysis Study sponsored by the U.S. National Institutes of Health. The adjusted odds ratios for each of the selected risk factors were estimated using a multivariable logistic regression model, controlling for the remaining risk factors, clinical center, and years on dialysis. RESULTS: Forty percent of the patients had coronary heart disease. Nineteen percent had cerebrovascular disease, and 23% had peripheral vascular disease. As expected, diabetes and smoking were strongly associated with cardiovascular diseases. Increasing age was also an important contributor, especially in the group less than 55 years and in nondiabetic patients. Black race was associated with a lower risk of cardiovascular diseases than non-blacks. Interestingly, neither serum total cholesterol nor predialysis systolic blood pressure was associated with coronary heart disease, cerebrovascular disease, or peripheral vascular disease. Further estimation of the coronary risks in our cohort using the Framingham coronary point score suggests that traditional risk factors are inadequate predictors of coronary heart disease in hemodialysis patients. CONCLUSIONS: Some of the traditional coronary risk factors in the general population appear to be also applicable to the hemodialysis population, while other factors did not correlate with atherosclerotic cardiovascular diseases in this cross-sectional study. Nontraditional risk factors, including the uremic milieu and perhaps the hemodialysis procedure itself, are likely to be contributory. Further studies are necessary to define the cardiovascular risk factors in order to devise preventive and interventional strategies for the chronic hemodialysis population.

Intermediate outcomes by race and ethnicity in peritoneal dialysis patients: results from the 1997 ESRD Core Indicators Project. National ESRD Core Indicators Workgroup.

BACKGROUND: Hispanics are the fastest growing minority group in the United States, and approximately 10% of all end-stage renal disease (ESRD) patients are Hispanic. Few data are available, however, regarding dialysis adequacy and anemia management in Hispanic patients receiving peritoneal dialysis in the U.S. METHODS: Data from the Health Care Financing Administration (HCFA) ESRD Core Indicators Project were used to assess racial and ethnic differences in selected intermediate outcomes for peritoneal dialysis patients. RESULTS: Of the 1219 patients for whom data were available from the 1997 sample, 9% were Hispanic, 24% were non-Hispanic blacks, and 59% were non-Hispanic whites. Hispanics were more likely to have diabetes mellitus as a cause of ESRD compared to blacks or whites, and both Hispanics and blacks were younger than white patients (both p < 0.001). Although whites had higher weekly Kt/V and creatinine clearance values compared to blacks or Hispanics (p < 0.05), blacks had been dialyzing longer (p < 0.01) and were more likely to be anuric compared to the other two groups (p < 0.001). Blacks had significantly lower mean hematocrit values (p < 0.001) and a greater proportion of patients who had a hematocrit level less than 28% (p < 0.05) compared to Hispanics or whites, despite receiving significantly larger weekly mean epoetin alfa doses (p < 0.05) and having significantly higher mean serum ferritin concentrations (p < 0.01). Multivariate logistic regression analysis revealed significant differences by race/ethnicity for experiencing a weekly Kt/V urea < 2.0 and hypertension, but not for other intermediate outcomes examined (weekly creatinine clearance < 60 L/week/1.73 m2, Hct < 30%, and serum albumin < 3.5/3.2 g/dL). CONCLUSION: Hispanics had adequacy values similar to blacks and anemia parameters similar to whites. Additional studies are needed to determine the etiologies of the differences in intermediate outcomes by racial and ethnic groupings in peritoneal dialysis patients.

Anemia management of adult hemodialysis patients in the US results: from the 1997 ESRD Core Indicators Project.

BACKGROUND: The Health Care Financing Administration's End-Stage Renal Disease (ESRD) Core Indicators Project collects clinical information on prevalent adult patients receiving in-center hemodialysis (HD) care in the United States to assess the quality of care delivered. Although hematocrit values, transferrin saturations, and iron prescription practices have improved over the last five years, we sought to determine whether continued opportunities for improvement of this domain of care exist. METHODS: A random sample of 7292 adult in-center HD patients was selected. Dialysis facility staff provided clinical information for the period of October through December 1996 for 6858 (94%) patients; complete laboratory information was available from 4991 (73%) returned forms. Hematocrit values, transferrin saturations, serum ferritin concentrations, epoetin alfa dosing, and iron prescriptions were abstracted from patient medical records to assess anemia management practices. RESULTS: The mean hematocrit for this cohort was 32.6 +/- 3.5%. Seventy-two percent of patients had hematocrit values> 30%. Forty-two percent had hematocrit values of 33 to 36%, and 10% were severely anemic (hematocrit <28%). Ninety-four percent of the patients received epoetin alfa intravenously (i.v.) and 6% subcutaneously. The mean weekly dose was 202.4 +/- 137.2 units/kg. The mean transferrin saturation was 27.4 +/- 12.6%; 73% of patients had a mean transferrin saturation > or = 20%. The mean serum ferritin concentration was 386 +/- 422 ng/mL; 79 and 12% of patients had a serum ferritin concentration of> 100 and> 800 ng/mL, respectively. Nine percent of the sample (N = 434) had a transferrin saturation <20% and serum ferritin concentration <100 ng/mL. Regardless of the patient's transferrin saturation, approximately three fourths of the patients received either oral or i.v. iron, and only approximately one half of the patients received i.v. iron. Of the subset of patients with transferrin saturation <20% and serum ferritin concentration <800 ng/mL, only 53% were prescribed intravenous iron. Multivariate linear regression analysis revealed that serum albumin, urea reduction ratio, age, and transferrin saturation were significantly positively associated with hematocrit. Epoetin alfa dose and serum ferritin concentration were significantly and negatively associated with the hematocrit (P < 0.001). CONCLUSION: Although substantial improvements have been made in anemia management for adult in-center HD patients over the past five years, significant opportunities persist to improve iron prescription practices.

Racial/ethnic analysis of selected intermediate outcomes for hemodialysis patients: results from the 1997 ESRD Core Indicators Project.

Principal goals of the End-Stage Renal Disease (ESRD) Core Indicators Project are to improve the care provided to ESRD patients and to identify categorical variability in intermediate outcomes of dialysis care. The purpose of the current analysis is to extend our observations about the variability of intermediate outcomes of ESRD care among different racial and gender groups to a previously unreported group, Hispanic Americans. This group is a significant and growing minority segment of the ESRD population. A random sample of Medicare-eligible adult, in-center, hemodialysis patients was selected and stratified from an end-of-year ESRD patient census for 1996. Of the 6,858 patients in the final sample, 45% were non-Hispanic whites, 36% were non-Hispanic blacks, and 11% were Hispanic. Whites were older than blacks or Hispanics (P < 0.001). Hispanics were more likely to have diabetes mellitus as a primary diagnosis than either blacks or whites (P < 0.001). Even though they received longer hemodialysis times and were treated with high-flux hemodialyzers, blacks had significantly lower hemodialysis doses than white or Hispanic patients (P < 0.001). The intradialytic weight losses were greater for blacks (P < 0.05). The delivered hemodialysis dose was lower for blacks than for whites or Hispanics whether measured as a urea reduction ratio (URR) or as the Kt/V calculated by the second generation formula of Daugirdas (median 1. 32, 1.36, and 1.37, respectively, P < 0.001). Hispanics and whites had modestly higher hematocrits than blacks (33.2, 33.2, and 33.0%, respectively, P < 0.01). There was no significant difference among groups in the weekly prescribed epoetin alfa dose ( approximately 172 units/kg/week). A significantly greater proportion of Hispanic patients had transferrin saturations >/=20% compared with the other two groups (P < 0.001). Logistic regression modeling revealed that whites were significantly more likely to have serum albumin <3. 5(BCG)/3.2(BCP) gm/dL (OR 1.4, p < 0.01); blacks were significantly more likely to have a delivered Kt/V < 1.2 (OR 1.4, P < 0.001) and hematocrit <30%, (OR 1.2; P < 0.05) and both blacks and Hispanics were significantly more likely to have a delivered URR < 65% (OR 1.5, P < 0.001 and 1.2, P < 0.05, respectively).

Erythropoietin and iron use in peritoneal dialysis patients. Report from the 1997 HCFA end-stage renal disease core indicators project.

The HCFA ESRD Core Indicators Project is designed to assess several key indicators of care in peritoneal dialysis patients, including anemia management. Information on hematocrit levels, epoetin alfa dosing, estimates of iron stores, and iron therapy as obtained in a national sample of 1,219 peritoneal dialysis patients are described. The average hematocrit was 32.8% +/- 3.8%, and severe anemia (hematocrit < 25%) occurred in 1.4% of PD patients. The mean weekly epoetin alfa dose was 134.6 U/kg. In general, there was an inverse relationship between hematocrit and epoetin alfa doses. Most (83%) of PD patients received iron therapy, with only 8% of patients receiving intravenous iron. The mean serum ferritin was 303 ng/mL, with 64% of patients having a ferritin greater than 100 ng/mL. The mean transferrin saturation was 28%, with 60% of patients having a value of less than 20%. There was an inverse relationship between serum ferritin levels and hematocrit but no relationship between hematocrit and transferrin. It is concluded that there could be improvement in the epoetin alfa and iron management in many patients.

1997 Peritoneal Dialysis-Core Indicators Study: Dialysis Adequacy and Nutritional Indicators Report.

The 1997 Peritoneal Dialysis-Core Indicators Study: Dialysis Adequacy and Nutritional Indicators Report documents the current status of peritoneal dialysis within the United States. A national random sample of adult peritoneal dialysis (PD) patients participating in the United States End Stage Renal Disease (ESRD) program was surveyed. PD subjects were large, with a mean body weight of 76 +/- 18.9 kg (mean +/- 1 SD) and a body mass index (BMI) of 27 +/- 6.4. The dialysis prescriptions documented achieved a mean weekly Kt/Vurea (wKt/V) and weekly creatinine clearance (wCrCl) of 2. 45 +/- 2.29 and 65.5 +/- 35.2 L/wk/1.73m2, respectively. The serum albumin of these patients was 3.5 +/- 0.48 g/dL, their normalized protein equivalent of nitrogen appearance (nPNA) 1.0 +/- 0.63 g/kg/d, and their normalized creatinine appearance rate (nCAR) 14 +/- 6.0 mg/kg/d. Serum albumin correlated meagerly but in a positive fashion with BMI, nPNA, and nCAR, and negatively with wCrCl. Among adult US PD patients, serum albumin values appear to correlate poorly with alternative measures of nutritional status and are inversely related to the intensity of renal replacement therapy. The presumptive dietary protein intake (nPNA) and creatinine appearance rate (nCAR) derived for PD patients do correlate in a positive fashion with dialysis delivery, at least up to a wCrCl of 60 to 80 L/wk/1.73 m2 and wKt/V = 2.1, but their values suggest that 30% to 50% of PD patients have marginal nutritional status.

Administration and pharmacokinetics of high-dose cyclophosphamide with hemodialysis support for allogeneic bone marrow transplantation in acute leukemia and end-stage renal disease.

We report a patient with pre-existing end-stage renal disease (ESRD) who underwent successful matched related donor allogeneic bone marrow transplantation for AML in second complete remission (CR2) using conditioning with high-dose cyclophosphamide (CY, 60 mg/kg/day x 2) and TBI (165 cGy twice daily x 4 days). The timing of hemodialysis after high-dose CY was extrapolated from available data on the pharmacokinetics of high-dose CY and hemodialysis clearance of conventional dose CY and its metabolites. Pharmacokinetic analyses indicated that the elimination of high-dose CY and its alkylating metabolites is impaired in ESRD but is cleared with hemodialysis. The patient's early post-transplant course was uncomplicated, and WBC and platelet engraftment occurred by day +22. Bone marrow examination on day +25 showed trilineage engraftment with no AML; cytogenetics showed 100% donor karyotype. The patient remains in remission with 100% donor karyotype at 3 years post transplant. Clinical results indicate that the administration of high-dose CY is feasible with hemodialysis support for patients with ESRD.

Trends in clinical indicators of care for adult peritoneal dialysis patients in the United States from 1995 to 1997. ESRD Core Indicators Workgroup.

BACKGROUND: This article describes the changes in four core indicator variables: dialysis adequacy, hematocrit, serum albumin, and blood pressure in peritoneal dialysis CAPD and cycler patients over a three-year period. METHODS: A national random sample of adult peritoneal dialysis patients in the United States was drawn each study period. Clinical data abstraction forms were completed by facility staff for patients selected for the sample, returned to the respective network, then forwarded to the Health Care Financing Administration for analysis. RESULTS: The mean weekly Kt/V urea for CAPD patients increased from 1.91 in 1995 to 2.12 in 1997 (P < 0.001) and for cycler patients, from 2.12 in 1996 to 2.24 in 1997 (P < 0.05). The mean weekly creatinine clearance for CAPD patients increased from 61.48 liter/week/1.73 m2 in 1995 to 65.84 liter/week/1.73 m2 in 1997 (P < 0.05). For cycler patients, it increased from 63.37 liter/week/1.73 m2 in 1996 to 67.45 liter/week/1.73 m2 in 1997 (P < 0.05). Despite this increase in adequacy values, less than 40% of peritoneal dialysis patients in 1997 had weekly Kt/V urea or creatinine clearance values that met subsequently published National Kidney Foundation's Dialysis Outcomes Quality Initiative (DOQI) guidelines. These data suggest that the dialysis prescription may not be adequately modified to compensate for increased body weight and for decreased residual renal function as years on dialysis increase. The average hematocrit value increased modestly in both CAPD and cycler patients from 1995 to 1997, and the number of patients with a hematocrit of less than 25% decreased from 6% in 1995 to 1.4% in 1997 (P < 0.001). Both serum albumin values and systolic and diastolic blood pressure values were essentially unchanged during the three-year period of observation. CONCLUSIONS: Despite improvements in dialysis adequacy and hematocrit values, there remains much room for improvement in these core indicator values.

Cycler adequacy and prescription data in a national cohort sample: the 1997 core indicators report. Health Care Financing Administration Peritoneal Dialysis Core Indicators Study Group.

BACKGROUND: The Health Care Financing Administration Peritoneal Dialysis Core Indicator Project obtains data yearly in four areas of patient care: dialysis adequacy, anemia, blood pressure, and nutrition. METHODS: Adequacy and dialysis prescription data were obtained using a standardized data abstraction form from a random sample of adult U.S. peritoneal dialysis patients who were alive on December 31, 1996. RESULTS: For the cohort receiving cycler dialysis, 22% were unable to meet the National Kidney Foundation Dialysis Outcome Quality Initiatives (NKF-DOQI) dialysis adequacy guidelines because they did not have at least one adequacy measure during the six-month period of observation. Thirty-six percent of patients met NKF-DOQI guidelines for weekly Kt/V urea, 33% met guidelines for weekly creatinine clearance (CCr), and 24% met guidelines for both urea and creatinine clearances. The mean weekly adequacy values were 2.24 +/- 0.56 for Kt/V urea and 67.5 +/- 24.4 liter/1.73 m2 for CCr, and the median values were 2.20 and 62.25 liter/1.73 m2, respectively. The mean prescribed 24-hour volume was 12,040 +/- 3255 ml, and the median prescribed volume was 11,783 ml. Only 60% of patients were prescribed at least one daytime dwell. By logistic regression analysis, risk factors for an inadequate dose of dialysis included being in the highest quartile of body surface area (odds ratio = 3.3 for CCr and 3.4 for Kt/V urea) and a duration of dialysis greater than two years (odds ratio = 4.2 for CCr and 2.1 for Kt/V urea). CONCLUSION: There is much room for improvement in providing an adequate dose of dialysis to cycler patients. Practitioners should be more aggressive in increasing dwell volumes, adding daytime dwells, and adjusting nighttime dwell times in order to compensate for the loss of residual renal function over time. These changes can only be accomplished if practitioners measure periodically the dose of dialysis as outlined in the NKF-DOQI guidelines.

Measurement of continuous ambulatory peritoneal dialysis prescription adherence using a novel approach.

OBJECTIVE: The purpose of the study was to test a novel approach to monitoring the adherence of continuous ambulatory peritoneal dialysis (CAPD) patients to their dialysis prescription. DESIGN: A descriptive observational study was done in which exchange behaviors were monitored over a 2-week period of time. SETTING: Patients were recruited from an outpatient dialysis center. PARTICIPANTS: A convenience sample of patients undergoing CAPD at Piedmont Dialysis Center in Winston-Salem, North Carolina was recruited for the study. Of 31 CAPD patients, 20 (64.5%) agreed to participate. MEASURES: Adherence of CAPD patients to their dialysis prescription was monitored using daily logs and an electronic monitoring device (the Medication Event Monitoring System, or MEMS; APREX, Menlo Park, California, U.S.A.). Patients recorded in their logs their exchange activities during the 2-week observation period. Concurrently, patients were instructed to deposit the pull tab from their dialysate bag into a MEMS bottle immediately after performing each exchange. The MEMS bottle was closed with a cap containing a computer chip that recorded the date and time each time the bottle was opened. RESULTS: One individual's MEMS device malfunctioned and thus the data presented in this report are based upon the remaining 19 patients. A significant discrepancy was found between log data and MEMS data, with MEMS data indicating a greater number and percentage of missed exchanges. MEMS data indicated that some patients concentrated their exchange activities during the day, with shortened dwell times between exchanges. Three indices were developed for this study: a measure of the average time spent in noncompliance, and indices of consistency in the timing of exchanges within and between days. Patients who were defined as consistent had lower scores on the noncompliance index compared to patients defined as inconsistent (p = 0.015). CONCLUSIONS: This study describes a methodology that may be useful in assessing adherence to the peritoneal dialysis regimen. Of particular significance is the ability to assess the timing of exchanges over the course of a day. Clinical implications are limited due to issues of data reliability and validity, the short-term nature of the study, the small sample, and the fact that clinical outcomes were not considered in this methodology study. Additional research is needed to further develop this data-collection approach.

Relationship between urea reduction ratio, demographic characteristics, and body weight for patients in the 1996 National ESRD Core Indicators Project.

The 1996 Health Care Financing Administration's (HCFA) Core Indicators Project for in-center, hemodialysis patients collects information on the quality of care delivered in four clinical areas that were anticipated to predict patient outcomes. Included among these clinical performance measurements is the delivered dose of hemodialysis, measured by the fractional reduction of urea achieved during a single hemodialysis session (urea reduction ratio [URR]). A random sample (N = 7,310) of adult (aged > or =18 years), in-center hemodialysis patients was selected, and a one-page data collection form for each patient was sent to the dialysis facility in which care was provided during the last quarter of 1995. The dialysis facilities provided information for 6,861 (94%) patients, and at least one paired predialysis and postdialysis blood urea nitrogen (BUN) concentration was reported for 6,655 (97%) of these patients. The URR of this cohort was 65.5% +/- 8.0% (mean +/- SD), and 41% of patients had a URR less than 65%. The mean dialysis session length was 203 minutes, and more than half of the patients received dialysis with a dialyzer membrane with a KUf less than 10 mL/mm Hg/h. The patients with a URR less than 65% had a mean body weight approximately 10 kg greater than patients with a URR of 65% or greater. This relationship was present for all demographic characteristics studied, including age, gender, race, and primary cause of end-stage renal disease (ESRD). Patients receiving dialysis for less than 6 months were more likely to have a URR less than 65% than patients on dialysis for longer periods. By multivariate analysis, variables significantly associated with a delivered URR less than 65% were body weight in the heaviest quartile (odds ratio [OR] = 6.1), male gender (OR = 2.6), on dialysis therapy less than 6 months (OR = 2.5), youngest quartile of age (<49 years) (OR = 2.0), lowest quartile of serum albumin values less than 3.6 g/dL (bromcresol green method) or less than 3.3 g/dL (bromcresol purple method) (OR = 1.6), black (OR = 1.5), dialyzed with a dialyzer KUf less than 20 mL/mm Hg/h (OR = 1.8), lowest quartile hematocrit (<29.7%) (OR = 1.2), and shorter dialysis session length (OR = 1.02/min). In conclusion, both patient-specific demographic variables and treatment-specific parameters are significantly associated with ESRD patients receiving a URR less than 65%. Furthermore, these data suggest statistically significant linkages between the delivered dose of hemodialysis and other independent outcome predictors such as serum albumin concentration. Prospective study is required to determine whether intervention strategies to improve the delivered dose of hemodialysis will affect this outcome predictor or whether serum albumin and dialysis dose share a common cause not amenable to increasing the URR.