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Biomedical subjects

Michael V Rocco

Publications and source records attributed to Michael V Rocco.

At least 19 recordsLinked to original sources
PubMed2006

Relationship between clinical performance measures and outcomes among patients receiving long-term hemodialysis.

BACKGROUND: Patients receiving long-term hemodialysis have a yearly mortality rate of 15% to 20%. OBJECTIVE: To determine whether attaining clinical performance measures for hemodialysis care is associated with favorable 12-month mortality and hospitalization rates. DESIGN: Cohort study. SETTING: Outpatient hemodialysis centers in the United States. PATIENTS: 15 287 patients who were selected from a 5% random sample of patients receiving long-term hemodialysis. MEASUREMENTS: The authors used data from the Centers for Medicare & Medicaid Services End-Stage Renal Disease Clinical Performance Measures Project from 1999 and 2000. The clinical performance measure targets were hemoglobin value of 110 g/L or greater; serum albumin value of 40 g/L or greater or 37 g/L or greater (bromcresol green and bromcresol purple laboratory methods, respectively); use of a fistula for vascular access; and measured single-pool Kt/V urea value of 1.2 or greater. The outcome measures were death or hospitalization during 1-year follow-up. RESULTS: 8364 patients (54.7%) were hospitalized and 3062 (20.0%) died during the 12-month follow-up period. Six percent of patients did not meet any clinical measure targets, 24% met 1 target, 39% met 2 targets, 24% met 3 targets, and 7% met all 4 targets. The unadjusted 12-month hospitalization and mortality rates for these 5 groups were 60%, 60%, 56%, 49%, and 43% (P < 0.001) and 29%, 25%, 21%, 14%, and 7% (P < 0.001), respectively. The risk for death increased for each additional guideline indicator that was not met: Adjusted hazard ratios were 4.6 (95% CI, 3.3 to 6.4), 3.5 (CI, 2.6 to 4.7), 2.6 (CI, 1.9 to 3.5), and 1.9 (CI, 1.4 to 2.6) for 0, 1, 2, or 3 targets met, respectively, compared with meeting 4 targets (referent). Similarly, the risk for hospitalization increased for each additional guideline indicator that was not met: Adjusted hazard ratios were 1.6 (CI, 1.4 to 1.9), 1.5 (CI, 1.3 to 1.7), 1.3 (CI, 1.1 to 1.5), and 1.1 (CI, 0.98 to 1.3), respectively. LIMITATIONS: It was not possible to determine the roles of severity of illness, other patient factors, or suboptimal care in failure to meet performance measures. CONCLUSIONS: In patients receiving long-term hemodialysis, meeting multiple clinical measure targets is associated with a decrease in hospitalization and mortality rates.

Anemia↗
PubMed2006

Hemodialysis timing, survival, and cardiovascular outcomes in the Hemodialysis (HEMO) Study.

BACKGROUND: The timing of medical therapies has been shown to influence the outcomes and side effects of treatments for disease. This report examines the extent to which hemodialysis treatment time of day was associated with cardiovascular mortality and morbidity and all-cause mortality in a secondary analysis of the Hemodialysis Study. METHODS: Dialysis start time defined dialysis shift: morning beginning between 0400 and 0930 hours (n = 822); midday, between 0930 and 1530 hours (n = 851); and evening, between 1530 and 2200 hours (n = 172). Outcome measures included all-cause mortality, cardiac death, composite end point of all-cause mortality or first cardiac hospitalization, and composite end point of first cardiac hospitalization or cardiac death. RESULTS: Morning hemodialysis was associated with a lower likelihood of cardiovascular events compared with the evening shift in all-cause mortality or first cardiac hospitalization (evening versus morning, relative risk [RR], 1.29; 95% confidence interval [CI], 1.01 to 1.65; P = 0.043), as well as first cardiac hospitalization or cardiac death (evening versus morning, RR, 1.44; 95% CI, 1.11 to 1.89; P = 0.007). No differences were noted in the other 2 outcomes, and there was no statistically significant difference between the morning and midday shifts. Although crude mortality rates were greater in the midday compared with morning (RR, 1.21; 95% CI, 1.05 to 1.39; P = 0.008), this association was attenuated after adjustment (RR, 1.04; 95% CI, 0.89 to 1.22; P = 0.64). CONCLUSION: Making extensive adjustment for patient characteristics, this report does not support the association of lower all-cause mortality with morning hemodialysis or a particular benefit for older patients.

Cardiovascular Diseases↗
PubMed2005

Serum beta-2 microglobulin levels predict mortality in dialysis patients: results of the HEMO study.

In the randomized Hemodialysis (HEMO) Study, chronic high-flux dialysis, as defined by higher beta-2 microglobulin (beta(2)M) clearance, compared with low-flux dialysis did not significantly alter all-cause mortality in the entire cohort but was associated with lower mortality in long-term dialysis patients. This analysis examined the determinants of serum beta(2)M levels and the associations of serum beta(2)M levels or dialyzer beta(2)M clearance with mortality. In a multivariable regression model that examined 1704 patients, baseline residual kidney urea clearance and dialyzer beta(2)M clearance were strong predictors of predialysis serum beta(2)M levels at 1 mo of follow-up, with regression coefficients of -7.21 (+/-0.69 SE) mg/L per ml/min per 35 L urea volume (P < 0.0001) and -1.94 (+/-0.30) mg/L per ml/min (P < 0.0001),respectively. In addition, black race and baseline years on dialysis correlated positively whereas age, diabetes, serum albumin, and body mass index correlated negatively with serum beta(2)M levels (P < 0.05). In time-dependent Cox regression models, mean cumulative predialysis serum beta(2)M levels but not dialyzer beta(2)M clearance were associated with all-cause mortality (relative risk = 1.11 per 10-mg/L increase in beta(2)M level; 95% confidence interval 1.05 to 1.19; P = 0.001), after adjustment for residual kidney urea clearance and number of prestudy years on dialysis. This association is supportive of the potential value of beta(2)M as a marker to guide chronic hemodialysis therapy.

Adult↗
PubMed2005

Self-reported appetite, hospitalization and death in haemodialysis patients: findings from the Hemodialysis (HEMO) Study.

BACKGROUND: Anorexia is an important cause of protein-energy malnutrition (PEM) in haemodialysis patients. We investigated whether self-reported appetite was associated with death and hospitalization in subjects enrolled in the Hemodialysis (HEMO) Study. METHODS: The HEMO Study was a 7-year, multicentre, randomized trial (N = 1846), which examined the effects of dialysis dose and membrane flux on mortality and morbidity. Three questions from the Appetite and Diet Assessment Tool (ADAT) were used to determine whether appetite had changed over time in the randomized treatment groups. The relations among ADAT scores, dietary protein and energy intakes, biochemical and anthropometric measures, and quality of life were assessed. We used Cox proportional hazards models to evaluate the relative risks of death and hospitalization associated with static and dynamic ADAT scores, adjusted for demographic factors, dose and flux assignments, and co-morbidity. RESULTS: The average length of follow-up was 2.84 years. After adjusting for demographic factors and randomized treatment assignments, there was a significant association between poorer self-reported appetite and death (RR 1.52, 95% CI 1.16-1.98); however, the association became non-significant with further adjustment for co-morbidity (RR 1.23, 95% CI 0.94-1.62). Poorer appetite was unequivocally associated with increased hospitalization rates (multivariable RR 1.35, 95% CI 1.13-1.61). The longitudinal effect of worsening appetite from baseline to 1 year was not associated with mortality or hospitalization rate after adjusting for co-morbidity. CONCLUSIONS: The association between appetite and death was confounded by co-morbidity. Self-reported appetite was associated with hospitalization rate in haemodialysis patients and, thus, it may be a useful screening tool for this outcome. Patients who report poor or very poor appetites should be monitored, and they should receive more comprehensive nutritional assessments.

Adolescent↗
PubMed2005

Multiple factors affect renal dietitians' use of the NKF-K/DOQI Adult Nutrition Guidelines.

OBJECTIVE: We investigated the components of the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative Nutrition Guidelines that are implemented by renal dietitians and the types of resources and support available to assist in implementing these guidelines. DESIGN AND PARTICIPANTS: A 49-item survey was mailed to 1694 dietitians in the United States. who were members of the National Kidney Foundation Council on Renal Nutrition in June 2003. The survey included sections on clinical practice, tools available to perform nutrition assessments, daily activities of the dietitian, and demographic and professional questions. RESULTS: Of the 1694 surveys mailed, 951 were returned (56% response rate); 848 were useable (89%). The primary employer was for-profit dialysis units (67%) and the mean (+/- SD) number of patients per dietitian was 104.9 +/- 48.3. Virtually all of the dietitians were aware of the nutrition guidelines (97%); 58% read all of the guidelines, whereas only 41% read some of the guidelines. Ninety-two percent of respondents implemented at least one guideline in their clinical practice; 72% and 55% had implemented 5 and 10 guidelines, respectively; but only 5% implemented all of the guidelines. Several barriers to implementation included lack of tools such as computers, calipers, and food models (57%); inadequate time including high dietitian-to-patient ratios (40%); and lack of administrative support from the dialysis unit (29%). CONCLUSIONS: There are multiple barriers that prevent the adequate assessment of the nutritional status of dialysis patients. Only after these resources are provided will it be possible to determine the impact of the nutrition guidelines on patient outcomes.

Adult↗
PubMed2005

Are nutritional status indicators associated with mortality in the Hemodialysis (HEMO) Study?

BACKGROUND: The purpose of this study was to determine if indicators of nutritional status were associated with subsequent mortality in hemodialysis patients. METHODS: Twelve selected nutrition indicators were measured prior to randomization in the Mortality and Morbidity in Hemodialysis (HEMO) Study. Relative risks (RR) of mortality were assessed at <6 months and >6 months of follow-up using Cox regression after controlling for case mix, comorbidity, and treatment assignment (high vs. standard Kt/V and high vs. low membrane flux). RESULTS: Low values of most nutritional status indicators were associated with increased RR of mortality. RRs were greatest over the short term (<6 months) and diminished with increasing follow-up (>6 months). Increases in body mass index (BMI) at lower levels (e.g., < or =25 kg/m(2)) and increases in serum albumin at any level were associated with reduced short-term RR, even after adjusting for case mix, treatment assignment, and for the joint effects of equilibrated normalized protein catabolic rate, total cholesterol, and serum creatinine. For >6 months' follow-up, increases in values among those with lower levels of BMI and serum albumin (< or =3.635 g/dL) and increases in all serum creatinine levels were associated with lower RR. CONCLUSION: Nutrition indicators are associated with subsequent mortality in a time-dependent manner, with greatest effects at <6 months of follow-up. The RR for these indicators may also vary within different ranges of values.

Body Mass Index↗
PubMed2004

Disparity in outcomes for adult Native American hemodialysis patients? Findings from the ESRD Clinical Performance Measures Project, 1996 to 1999.

BACKGROUND: There is a paucity of information regarding the quality of care for Native American hemodialysis patients. Outcomes, including 1-year hospitalization and mortality, for adult Native American in-center hemodialysis patients selected for the Centers for Medicare and Medicaid (CMS) end-stage renal disease (ESRD) Clinical Performance Measures (CPM) Project were compared to those for white and black patients to determine if disparity in care existed for this group. METHODS: Clinical data were abstracted from medical records for the last quarters of 1995 to 1998 and linked to United States Renal Data System (USRDS) data files for data on comorbidities and 1-year hospitalization and mortality. Associations of race were tested by bivariate analyses and multivariate logistic regression and Cox proportional hazard modeling. RESULTS: Two percent (467 of 27876) of patients were Native American, 37% black, and 51% white. Native American, compared to black and white patients, were more likely to have diabetes mellitus as the cause of ESRD (72%, 37%, and 38%, respectively, P < 0.01). In multivariate analyses, Native American patients were more likely to achieve a mean urea reduction ratio (URR) > or = 65% compared to whites (referent) [hazards ratio (HR) (95% CI) 1.7 (1.3, 2.2)] and be dialyzed with an arteriovenous fistula [HR (95% CI) 1.7 (1.2, 2.5)]. They were as likely as Whites to achieve a mean hematocrit > or =33% and a mean serum albumin > or =4.0/3.7 g/dL. In multivariate analyses, Native Americans were no more likely to be hospitalized or die during the follow-up period than whites. CONCLUSION: These data suggest that adult Native American hemodialysis patients experience equivalent or better dialytic care and are no more likely to experience 1-year hospitalization or mortality compared to whites.

Aged↗
PubMed2004

The effect of dialysis dose and membrane flux on nutritional parameters in hemodialysis patients: results of the HEMO Study.

BACKGROUND: The effect of standard or high dialysis dose and low or high dialysis flux on nutritional status was ascertained in 1846 maintenance hemodialysis patients enrolled in the HEMO Study. METHODS: Serum albumin levels, equilibrated protein catabolic rate, and postdialysis weight were obtained monthly, while adjusted protein and energy intake, self-reported appetite assessment, upper arm circumference, and calf circumference were obtained yearly. To account for patient attrition due to death or transfer, three statistical models were used to test the effects of the study interventions on longitudinal changes in nutritional parameters. RESULTS: During the first 3 years of follow-up, neither mean serum albumin levels, which declined by 0.21 g/dL, nor mean postdialysis weight, which declined by 2.7 kg, were significantly affected by either study intervention. Mean levels of all anthropometric measures declined during follow-up. For years 1, 2, and 3, the mean +/- SE declines in upper arm and calf circumferences were 0.35 +/- 0.16 cm (P= 0.031) and 0.31 +/- 0.13 (P= 0.015) cm less, respectively, in the high flux compared to the low flux group. Appetite scores and mean equilibrated protein catabolic rate also declined in all randomized groups; however, the average decline in equilibrated protein catabolic rate during years 1, 2, and 3 was 0.019 +/- 0.007 g/kg/day less in the high dose than the standard dose group (P= 0.007). There was no significant change in either mean energy or protein intake from diet records over time, and neither parameter was affected by the study interventions. CONCLUSION: Although the dose and flux interventions may subtly influence certain nutritional parameters, neither intervention prevented deterioration in nutritional status over time.

Adult↗
PubMed2004

Diabetes is the strongest risk factor for lower-extremity amputation in new hemodialysis patients.

OBJECTIVE: End-stage renal disease (ESRD) patients, especially those with diabetes, have an increased risk of nontraumatic lower-extremity amputation (LEA). The present study aims to examine the association of demographic and clinical variables with the risk of hospitalization for LEA among incident hemodialysis patients. RESEARCH DESIGN AND METHODS: The study population consisted of incident hemodialysis patients from the study years 1996-1999 of the ESRD Core Indicator/Clinical Performance Measures (CPM) Project. Cox proportional hazard modeling was used to identify factors associated with LEA. RESULTS: Four percent (116 of 3,272) of noncensored incident patients had an LEA during the 12-month follow-up period. Factors associated with LEA included diabetes as the cause of ESRD or preexisting comorbidity (hazard ratio 6.4, 95% CI 3.4-12.0), cardiovascular comorbidity (1.8, 1.2-2.8), hemodialysis inadequacy (urea reduction ratio [URR] <58.5% (1.9, 1.1-3.3), and lower serum albumin level (1.6, 1.1-2.3). Among patients with diabetes, hemodialysis inadequacy and cardiovascular comorbidity were risk factors for LEA (2.6, 1.4-4.8, and 1.7, 1.1-2.6, respectively). CONCLUSIONS: These data suggest that diabetes is a potent risk factor for LEA in new hemodialysis patients. In ESRD patients with diabetes, a multipronged approach may reduce the rate of LEA. Potentially beneficial strategies include adherence to hemodialysis adequacy guidelines, aggressive treatment of cardiovascular comorbidities, and the utilization of LEA prevention strategies recommended for the general population of patients with diabetes.

Adolescent↗
PubMed2003

Response to inadequate dialysis in chronic peritoneal dialysis patients. Results from the 2000 Centers for Medicare and Medicaid (CMS) ESRD Peritoneal Dialysis Clinical Performance Measures (PD-CPM) Project.

BACKGROUND: It is not known if patient prescriptions are being changed if patients are receiving an inadequate dose of peritoneal dialysis. METHODS: Data from the 2000 Centers for Medicare and Medicaid were used to obtain data on dialysis adequacy and dialysis prescriptions. RESULTS: A total of 359 of 1,268 (28%) adult peritoneal dialysis patients had a total weekly Kt/V urea (twKt/V) less than 2.0 and 436 of 1,245 (35%) patients had a total weekly creatinine clearance (twCrCl) less than 60 L/wk/1.73 m2, defined as "inadequate dialysis." Among chronic ambulatory peritoneal dialysis (CAPD) patients, 81 of 188 (43%) patients had inadequate dialysis and a change in the peritoneal dialysis prescription within 6 months of the initial adequacy value. Among cycler patients, 106 of 197 (54%) patients had inadequate dialysis and a change in the prescription. Thirty-six of 46 (78%) CAPD patients and 48 of 56 (86%) cycler patients had an improvement in twKt/V after the prescription was revised. Thirty-two of 42 (76%) CAPD patients and 45 of 57 (79%) cycler patients had an improvement in twCrCl after the prescription was changed. For these patients, twKt/V increased from 1.6 +/- 0.3 to 2.1 +/- 0.5, with an increase in the peritoneal Kt/V urea from 1.5 +/- 0.3 to 1.9 +/- 0.4. Similarly, twCrCl increased from 46.3 +/- 7.5 to 59.1 +/- 10.6 L/wk/1.73 m2 with an increase in the peritoneal CrCl dose from 42.0 +/- 9.1 to 52.7 +/- 9.9 L/wk/1.73 m2. CONCLUSION: About half of peritoneal dialysis patients with inadequate dialysis did not have a prescription change and could benefit from modifications in their dialysis prescription.

Adult↗
PubMed2003

Effects of dietary intake, appetite, and eating habits on dialysis and non-dialysis treatment days in hemodialysis patients: cross-sectional results from the HEMO study.

OBJECTIVE: To evaluate differences between dietary energy intake (DEI), dietary protein intake (DPI), appetite, dietary patterns, and eating habits during dialysis treatment days (DD) and non-dialysis treatment days (NDD) in 1,901 adults receiving maintenance hemodialysis who were enrolled in the baseline phase of the National Institutes of Health-sponsored Hemodialysis (HEMO) study. DESIGN: A cross-sectional analysis of participants at baseline (before randomization). SETTING: Fifteen clinical centers across the United States. MEASUREMENTS: DEI, DPI, and self-reported assessment of appetite, dietary patterns, and eating habits. RESULTS: For the entire study cohort, total mean (+/- SD) DEI (1,566 +/- 636 kcal/day) and weight-adjusted DEI (23.2 +/- 9.5 kcal/kg/day) were significantly higher (P <.0001) on NDD than on DD (1,488 +/- 620 kcal/day and 22.2 +/- 9.6 kcal/kg/day), respectively. Similarly, DPI was significantly higher (P <.0001) on NDD (65.0 +/- 29.0 g/day and 0.96 +/- 0.43 g/kg/day) than on DD (60.2 +/- 26.5 g/day and 0.90 +/- 0.41 g/kg/day). On DD and NDD, the mean weight-adjusted DEI for the entire cohort was less than the HEMO study standard of care (SOC) of > or =28 kcal/kg/day, whereas on NDD, several subgroups reported dietary protein intakes that were closer to the study's SOC. These included men, patients under 50 years of age, nonblack participants, those without diabetes, those with a normal or mild Index of Co-Existing Disease score, and those on dialysis for more than 5 years. Protein and energy intakes declined with worsening self-reported appetites in both DD and NDD after adjusting for other subgroup effects. CONCLUSION: Dietary energy and protein intakes of HEMO study participants were lower on DD than on NDD, and also lower than the SOC on both days, particularly with regard to energy intake. People receiving maintenance hemodialysis should be counseled to consume adequate amounts of energy and protein daily, especially on DD. Practitioners should monitor closely those patients who report poor appetite and should intervene appropriately.

Adult↗
PubMed2003

Differences in intermediate outcomes for Asian and non-Asian adult hemodialysis patients in the United States.

BACKGROUND: There is a paucity of information regarding the clinical experience of Asian hemodialysis patients. This paper describes intermediate outcomes for adult Asian hemodialysis patients compared to Caucasians and African Americans. METHODS: Dialysis facility staff abstracted clinical information on a national random sample of adult hemodialysis patients from October through December 2000. Associations of race with intermediate outcomes were tested by bivariate analyses and multivariable logistic regression modeling. RESULTS: A total of 429 patients were identified as Asian, 4403 as Caucasians, and 3103 as African Americans. Asian and Caucasian patients were older than African Americans [mean 63.2 (+/-15.6), 63.9 (+/-15.2), and 57.7 (+/-14.7) years, P < 0.001], and had fewer years on dialysis [mean 3.5 (+/-3.8), 3.1 (+/-3.8), and 4.1 (+/-4.1) years, P < 0.001]. Ninety three percent of Asians, 87% of Caucasians, and 84% of African Americans had a mean Kt/V > or =1.2 (P < 0.001). In addition, 36% of Asians, 32% of Caucasians, and 26% of African Americans had an arteriovenous (AV) fistula as their vascular access (P < 0.001). Hemoglobin profiles were only slightly different among the three racial groups. More Asians and African Americans had a mean serum albumin > or =4.0/3.7 g/dL compared to Caucasians (33% and 31% compared to 27%, respectively, P < 0.001). In the final multivariable logistic regression model, Asians were twice as likely to have a mean Kt/V > or =1.2 compared to Caucasians (the referent group) [odds ratio (OR) (95% CI) 2.10 (1.33, 3.32), P < 0.01]. They experienced similar intermediate outcomes for vascular access, anemia management, and serum albumin compared to the majority racial group. CONCLUSION: These findings indicate that adult hemodialysis Asian patients experience similar or better intermediate outcomes compared to the majority racial group. Further study is needed to determine if these results are associated with improved survival and less morbidity in this minority group.

Adolescent↗
PubMed2003

Survival advantage for adult Hispanic hemodialysis patients? Findings from the end-stage renal disease clinical performance measures project.

One-year follow-up mortality in Hispanic and non-Hispanic patients and its association with intermediate outcomes of dialytic care were examined utilizing the Center for Medicare & Medicaid Services' (CMS) ESRD Clinical Performance Measures (CPM) Project and administrative data. Demographic and clinical information was collected on a national random sample of adult in-center hemodialysis (HD) patients for the period of October through December, 1998. Patients were categorized as Hispanic, non-Hispanic White, or non-Hispanic Black. Of 8336 patients 994 (12%) were identified as Hispanic, 3618 (43%) as non-Hispanic White, and 3111 (37%) as non-Hispanic Black. The adjusted 12-mo mortality risk (99% CI) for Hispanics was 0.76 (0.60 to 0.96; P < 0.01) and for non-Hispanic Blacks 0.66 (0.56 to 0.78, P < 0.001) compared with non-Hispanic Whites (referent). Similar 12-mo mortality risks were noted in the groups with diabetes mellitus or hypertension as the causes of ESRD and among patients > or = 65 yr. After controlling for demographic and geographic variables, Hispanics compared with the referent group, non-Hispanic Whites, were more likely to have a mean serum albumin > or = 4.0/3.7 g/dL (BCG/BCP) (1.5 [1.2 to 1.7]; P < 0.001) and as likely to have a mean Kt/V > or = 1.2, mean hemoglobin > or = 11 g/dL, and an arteriovenous fistula as their vascular access. These data suggest that adult Hispanic HD patients have a 12-mo survival intermediate to non-Hispanic Blacks and non-Hispanic Whites and experience equivalent or better intermediate outcomes of dialytic care compared with non-Hispanic Whites.

Adult↗
PubMed2003

Effects of high-flux hemodialysis on clinical outcomes: results of the HEMO study.

Among the 1846 patients in the HEMO Study, chronic high-flux dialysis did not significantly affect the primary outcome of the all-cause mortality (ACM) rate or the main secondary composite outcomes, including the rates of first cardiac hospitalization or ACM, first infectious hospitalization or ACM, first 15% decrease in serum albumin levels or ACM, or all non-vascular access-related hospitalizations. The high-flux intervention, however, seemed to be associated with reduced risks of specific cardiac-related events. The relative risks (RR) for the high-flux arm, compared with the low-flux arm, were 0.80 [95% confidence interval (CI), 0.65 to 0.99] for cardiac death and 0.87 (95% CI, 0.76 to 1.00) for the composite of first cardiac hospitalization or cardiac death. Also, the effect of high-flux dialysis on ACM seemed to vary, depending on the duration of prior dialysis. This report presents secondary analyses to further explore the relationship between the flux intervention and the duration of dialysis with respect to various outcomes. The patients were stratified into a short-duration group and a long-duration group, on the basis of the mean duration of dialysis of 3.7 yr before randomization. In the subgroup that had been on dialysis for >3.7 yr, randomization to high-flux dialysis was associated with lower risks of ACM (RR, 0.68; 95% CI, 0.53 to 0.86; P = 0.001), the composite of first albumin level decrease or ACM (RR, 0.74; 95% CI, 0.60 to 0.91; P = 0.005), and cardiac deaths (RR, 0.63; 95% CI, 0.43 to 0.92; P = 0.016), compared with low-flux dialysis. No significant differences were observed in outcomes related to infection for either duration subgroup, however, and the trends for beneficial effects of high-flux dialysis on ACM rates were considerably weakened when the years of dialysis during the follow-up phase were combined with the prestudy years of dialysis in the analysis. For the subgroup of patients with <3.7 yr of dialysis before the study, assignment to high-flux dialysis had no significant effect on any of the examined clinical outcomes. These data suggest that high-flux dialysis might have a beneficial effect on cardiac outcomes. Because these results are derived from multiple statistical comparisons, however, they must be interpreted with caution. The subgroup results that demonstrate that patients with different durations of dialysis are affected differently by high-flux dialysis are interesting and require further study for confirmation.

Female↗
PubMed2002

Effect of dialysis dose and membrane flux in maintenance hemodialysis.

BACKGROUND: The effects of the dose of dialysis and the level of flux of the dialyzer membrane on mortality and morbidity among patients undergoing maintenance hemodialysis are uncertain. METHODS: We undertook a randomized clinical trial in 1846 patients undergoing thrice-weekly dialysis, using a two-by-two factorial design to assign patients randomly to a standard or high dose of dialysis and to a low-flux or high-flux dialyzer. RESULTS: In the standard-dose group, the mean (+/-SD) urea-reduction ratio was 66.3+/-2.5 percent, the single-pool Kt/V was 1.32+/-0.09, and the equilibrated Kt/V was 1.16+/-0.08; in the high-dose group, the values were 75.2+/-2.5 percent, 1.71+/-0.11, and 1.53+/-0.09, respectively. Flux, estimated on the basis of beta2-microglobulin clearance, was 3+/-7 ml per minute in the low-flux group and 34+/-11 ml per minute in the high-flux group. The primary outcome, death from any cause, was not significantly influenced by the dose or flux assignment: the relative risk of death in the high-dose group as compared with the standard-dose group was 0.96 (95 percent confidence interval, 0.84 to 1.10; P=0.53), and the relative risk of death in the high-flux group as compared with the low-flux group was 0.92 (95 percent confidence interval, 0.81 to 1.05; P=0.23). The main secondary outcomes (first hospitalization for cardiac causes or death from any cause, first hospitalization for infection or death from any cause, first 15 percent decrease in the serum albumin level or death from any cause, and all hospitalizations not related to vascular access) also did not differ significantly between either the dose groups or the flux groups. Possible benefits of the dose or flux interventions were suggested in two of seven prespecified subgroups of patients. CONCLUSIONS: Patients undergoing hemodialysis thrice weekly appear to have no major benefit from a higher dialysis dose than that recommended by current U.S. guidelines or from the use of a high-flux membrane.

Adult↗
PubMed2002

Potential cost savings of erythropoietin administration in end-stage renal disease.

BACKGROUND: In a Department of Veterans Affairs randomized controlled trial, a lower dose of recombinant human erythropoietin (epoetin) was shown to attain target hematocrit levels when administered subcutaneously compared with intravenously. Since epoetin is expensive, optimizing the therapeutic effect of epoetin using a strategy that includes subcutaneous administration could lead to substantial cost savings. METHODS: We used an economic cost projection model to estimate potential savings to the Medicare End-Stage Renal Disease Program that could occur during a transition from intravenous to subcutaneous administration of epoetin among hemodialysis patients. Data included clinical results from the Department of Veterans Affairs randomized controlled trial, the 1998 Centers for Medicare and Medicaid Services' End-Stage Renal Disease Core Indicators Survey, and the 1997-1998 Medicare claims files. In sensitivity analyses, we varied the expected dose reductions (10% to 50%) and the proportion of patients (25% to 100%) who switched to subcutaneous administration. RESULTS: Medicare cost savings were estimated at $47 to $142 million annually as 25% to 75% of hemodialysis patients who received epoetin intravenously switched to subcutaneous administration while reducing the dose by 32%. A minimal reduction (10%) in epoetin dose would result in Medicare cost savings of an estimated $15 to $44 million annually. CONCLUSION: Administering epoetin subcutaneously would provide substantial cost savings to Medicare. For the transition to occur, consensus among stakeholders is needed, especially among patients whose treatment satisfaction and health-related quality of life would be most affected.

Costs and Cost Analysis↗