Effect of frequent nocturnal hemodialysis vs conventional hemodialysis on left ventricular mass and quality of life: a randomized controlled trial.
TL;DR: This preliminary study revealed that frequent nocturnal hemodialysis improved left ventricular mass, reduced the need for blood pressure medications, improved some measures of mineral metabolism, and improved selected measures of quality of life.
Abstract: ContextMorbidity and mortality rates in hemodialysis patients remain excessive. Alterations in the delivery of dialysis may lead to improved patient outcomes.ObjectiveTo compare the effects of frequent nocturnal hemodialysis vs conventional hemodialysis on change in left ventricular mass and health-related quality of life over 6 months.Design, Setting, and ParticipantsA 2-group, parallel, randomized controlled trial conducted at 2 Canadian university centers between August 2004 and December 2006. A total of 52 patients undergoing hemodialysis were recruited.InterventionParticipants were randomly assigned in a 1:1 ratio to receive nocturnal hemodialysis 6 times weekly or conventional hemodialysis 3 times weekly.Main Outcome MeasuresThe primary outcome was change in left ventricular mass, as measured by cardiovascular magnetic resonance imaging. The secondary outcomes were patient-reported quality of life, blood pressure, mineral metabolism, and use of medications.ResultsFrequent nocturnal hemodialysis significantly improved the primary outcome (mean left ventricular mass difference between groups, 15.3 g, 95% confidence interval [CI], 1.0 to 29.6 g; P = .04). Frequent nocturnal hemodialysis did not significantly improve quality of life (difference of change in EuroQol 5-D index from baseline, 0.05; 95% CI, −0.07 to 0.17; P = .43). However, frequent nocturnal hemodialysis was associated with clinically and statistically significant improvements in selected kidney-specific domains of quality of life (P = .01 for effects of kidney disease and P = .02 for burden of kidney disease). Frequent nocturnal hemodialysis was also associated with improvements in systolic blood pressure (P = .01 after adjustment) and mineral metabolism, including a reduction in or discontinuation of antihypertensive medications (16/26 patients in the nocturnal hemodialysis group vs 3/25 patients in the conventional hemodialysis group; P < .001) and oral phosphate binders (19/26 patients in the nocturnal hemodialysis group vs 3/25 patients in the conventional dialysis group; P < .001). No benefit in anemia management was seen with nocturnal hemodialysis.ConclusionThis preliminary study revealed that, compared with conventional hemodialysis (3 times weekly), frequent nocturnal hemodialysis improved left ventricular mass, reduced the need for blood pressure medications, improved some measures of mineral metabolism, and improved selected measures of quality of life.Trial Registrationisrctn.org Identifier: ISRCTN25858715
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University of California, San Francisco1, University of California, Davis2, Cleveland Clinic3, University of Western Ontario4, University of California, San Diego5, Washington University in St. Louis6, Case Western Reserve University7, Ohio State University8, University of California, Los Angeles9, Wake Forest University10, Vanderbilt University11, El Camino Hospital12, University of Pittsburgh13, Yale University14
TL;DR: Frequent hemodialysis, as compared with conventional hemodIALysis, was associated with favorable results with respect to the composite outcomes of death or change in left ventricular mass and death orchange in a physical-health composite score but prompted more frequent interventions related to vascular access.
Abstract: Background In this randomized clinical trial, we aimed to determine whether increasing the frequency of in-center hemodialysis would result in beneficial changes in left ventricular mass, self-reported physical health, and other intermediate outcomes among patients undergoing maintenance hemodialysis. Methods Patients were randomly assigned to undergo hemodialysis six times per week (frequent hemodialysis, 125 patients) or three times per week (conventional hemodialysis, 120 patients) for 12 months. The two coprimary composite outcomes were death or change (from baseline to 12 months) in left ventricular mass, as assessed by cardiac magnetic resonance imaging, and death or change in the physical-health composite score of the RAND 36-item health survey. Secondary outcomes included cognitive performance; self-reported depression; laboratory markers of nutrition, mineral metabolism, and anemia; blood pressure; and rates of hospitalization and of interventions related to vascular access. Results Patients in the frequent-hemodialysis group averaged 5.2 sessions per week; the weekly standard Kt/V(urea) (the product of the urea clearance and the duration of the dialysis session normalized to the volume of distribution of urea) was significantly higher in the frequent-hemodialysis group than in the conventional-hemodialysis group (3.54±0.56 vs. 2.49±0.27). Frequent hemodialysis was associated with significant benefits with respect to both coprimary composite outcomes (hazard ratio for death or increase in left ventricular mass, 0.61; 95% confidence interval [CI], 0.46 to 0.82; hazard ratio for death or a decrease in the physical-health composite score, 0.70; 95% CI, 0.53 to 0.92). Patients randomly assigned to frequent hemodialysis were more likely to undergo interventions related to vascular access than were patients assigned to conventional hemodialysis (hazard ratio, 1.71; 95% CI, 1.08 to 2.73). Frequent hemodialysis was associated with improved control of hypertension and hyperphosphatemia. There were no significant effects of frequent hemodialysis on cognitive performance, self-reported depression, serum albumin concentration, or use of erythropoiesis-stimulating agents. Conclusions Frequent hemodialysis, as compared with conventional hemodialysis, was associated with favorable results with respect to the composite outcomes of death or change in left ventricular mass and death or change in a physical-health composite score but prompted more frequent interventions related to vascular access. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT00264758.).
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TL;DR: Atorvastatin had no statistically significant effect on the composite primary end point of cardiovascular death, nonfatal myocardial infarction, and stroke in patients with diabetes receiving hemodialysis.
Abstract: BACKGROUND
Statins reduce the incidence of cardiovascular events in persons with type 2 diabetes mellitus. However, the benefit of statins in such patients receiving hemodialysis, who are at high risk for cardiovascular disease and death, has not been examined.
METHODS
We conducted a multicenter, randomized, double-blind, prospective study of 1255 subjects with type 2 diabetes mellitus receiving maintenance hemodialysis who were randomly assigned to receive 20 mg of atorvastatin per day or matching placebo. The primary end point was a composite of death from cardiac causes, nonfatal myocardial infarction, and stroke. Secondary end points included death from all causes and all cardiac and cerebrovascular events combined.
RESULTS
After four weeks of treatment, the median level of low-density lipoprotein cholesterol was reduced by 42 percent among patients receiving atorvastatin, and among those receiving placebo it was reduced by 1.3 percent. During a median follow-up period of four years, 469 patients (37 percent) reached the primary end point, of whom 226 were assigned to atorvastatin and 243 to placebo (relative risk, 0.92; 95 percent confidence interval, 0.77 to 1.10; P=0.37). Atorvastatin had no significant effect on the individual components of the primary end point, except that the relative risk of fatal stroke among those receiving the drug was 2.03 (95 percent confidence interval, 1.05 to 3.93; P=0.04). Atorvastatin reduced the rate of all cardiac events combined (relative risk, 0.82; 95 percent confidence interval, 0.68 to 0.99; P=0.03, nominally significant) but not all cerebrovascular events combined (relative risk, 1.12; 95 percent confidence interval, 0.81 to 1.55; P=0.49) or total mortality (relative risk, 0.93; 95 percent confidence interval, 0.79 to 1.08; P=0.33).
CONCLUSIONS
Atorvastatin had no statistically significant effect on the composite primary end point of cardiovascular death, nonfatal myocardial infarction, and stroke in patients with diabetes receiving hemodialysis.
790 citations
TL;DR: The 2015 update of the KDOQI Clinical Practice Guideline for Hemodialysis Adequacy is intended to assist practitioners caring for patients in preparation for and during hemodialysis.
722 citations
Cites background or methods or result from "Effect of frequent nocturnal hemodi..."
...) Unfortunately, results from these trials were equivocal due to very small sample sizes (Alberta Trial, N 5 52; FHN Nocturnal Trial, N 5 87).(8,11) Both trials demonstrated statistically better BP and phosphate control with home long frequent HD, but no improvement in anemia....
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...The Work Group also recognizes that cost or staffing considerations may affect the ability of an individual dialysis center to provide in-center short frequent HD. Finally, these recommendations do not apply to short home HD therapies or to dialysis prescriptions that are substantially dissimilar (eg, slow dialysate flow rates) to the FHN Daily Study prescriptions....
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...This study’s findings were refuted by the same authors some years later with a newer analysis showing that all types of kidney transplantation had superior survival compared to home long frequent HD.121 Preliminary data from extended follow-up of participants in the FHN Nocturnal Trial showed no survival benefit, and possibly an increase in mortality with home long frequent HD.116 It is difficult to interpret these mortality data given the high nonadherence rate with home long frequent treatment, as well as the large percentage of crossovers in both arms after the main trial ended.116 Additional data on causes of death and hospitalization in this extended follow-up period have not yet been reported....
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...Mean differences in these variables (frequent minus conventional groups) were: 213.8 g, 10.1 mm Hg, 20.64 medications per day, 20.46 mg/dL, and 21.35 g equivalent phosphate-binder doses per day).9,99,100 On the other hand, there were no improvements in serum albumin levels,101 cognitive function as measured by the Trailmaking Test Part B,102 depression as measured by the Beck Depression Inventory, mental health as measured by the mental health composite of the RAND,103 or objective measures of physical performance.104 Hemoglobin levels decreased by a mean of 0.29 mg/dL in the conventional group compared to a stable hemoglobin level in the more frequent group (P 5 0.03), while there was no difference in doses of erythropoiesis-stimulating agents (ESAs).105 The FHN Daily Trial also identified certain risks associated with in-center short frequent HD. Compared with patients receiving conventional HD, 904 patients randomized to in-center short frequent HD had a statistically significant increased risk of vascular access repairs (hazard ratio [HR], 1.68; 95% confidence interval [CI], 1.13-2.51; P 5 0.01), primarily driven by increased vascular access repairs in the subgroup of patients with AV accesses at baseline.106 All types of repairs appeared to be more prevalent with frequent compared to conventional HD, including angioplasties, thrombectomies, and surgical revisions....
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...To date, just 1 randomized trial of short frequent HD has been completed.9 The Work Group is unaware of any randomized trials of home short frequent HD and thus the group developed guideline statements only for in-center short frequent HD....
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TL;DR: Hemodialysis-induced myocardial stunning is common, and may contribute to the development of heart failure and increased mortality in HD patients, which may provide novel therapeutic targets to reduce currently excessive rates of cardiovascular morbidity and mortality.
Abstract: Background and objectives: Hemodialysis (HD)-induced myocardial stunning driven by ischemia is a recognized complication of HD, which can be ameliorated by HD techniques that improve hemodynamics. In nondialysis patients, repeated ischemia leads to chronic reduction in left ventricular (LV) function. HD may initiate and drive the same process. In this study, we examined the prevalence and associations of HD-induced repetitive myocardial injury and long-term effects on LV function and patient outcomes. Design, setting, participants, & measurements: Seventy prevalent HD patients were assessed for evidence of subclinical myocardial injury at baseline using serial echocardiography and followed up after 12 mo. Intradialytic blood pressure, hematologic and biochemical samples, and patient demographics were also collected at both time points. Results: Sixty-four percent of patients had significant myocardial stunning during HD. Age, ultrafiltration volumes, intradialytic hypotension, and cardiac troponin-T (cTnT) levels were independent determinants associated with its presence. Myocardial stunning was associated with increased relative mortality at 12 mo (P = 0.019). Cox regression analysis showed increased hazard of death in patients with myocardial stunning and elevated cTnT than in patients with elevated cTnT alone (P Conclusions: HD-induced myocardial stunning is common, and may contribute to the development of heart failure and increased mortality in HD patients. Enhanced understanding of dialysis-induced cardiac injury may provide novel therapeutic targets to reduce currently excessive rates of cardiovascular morbidity and mortality.
579 citations
Cites background from "Effect of frequent nocturnal hemodi..."
...More frequent daily or nocturnal HD therapies can improve cardiovascular outcome measures and quality of life (26,27)....
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References
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TL;DR: The estimation of left ventricular mass by echocardiography offers prognostic information beyond that provided by the evaluation of traditional cardiovascular risk factors, and it is concluded that an increase in left Ventricular mass predicts a higher incidence of clinical events, including death, attributable to cardiovascular disease.
Abstract: A pattern of left ventricular hypertrophy evident on the electrocardiogram is a harbinger of morbidity and mortality from cardiovascular disease. Echocardiography permits the noninvasive determination of left ventricular mass and the examination of its role as a precursor of morbidity and mortality. We examined the relation of left ventricular mass to the incidence of cardiovascular disease, mortality from cardiovascular disease, and mortality from all causes in 3220 subjects enrolled in the Framingham Heart Study who were 40 years of age or older and free of clinically apparent cardiovascular disease, in whom left ventricular mass was determined echocardiographically. During a four-year follow-up period, there were 208 incident cardiovascular events, 37 deaths from cardiovascular disease, and 124 deaths from all causes. Left ventricular mass, determined echocardiographically, was associated with all outcome events. This relation persisted after we adjusted for age, diastolic blood pressure, pulse pressure, treatment for hypertension, cigarette smoking, diabetes, obesity, the ratio of total cholesterol to high-density lipoprotein cholesterol, and electrocardiographic evidence of left ventricular hypertrophy. In men, the risk factor-adjusted relative risk of cardiovascular disease was 1.49 for each increment of 50 g per meter in left ventricular mass corrected for the subject's height (95 percent confidence interval, 1.20 to 1.85); in women, it was 1.57 (95 percent confidence interval, 1.20 to 2.04). Left ventricular mass (corrected for height) was also associated with the incidence of death from cardiovascular disease (relative risk, 1.73 [95 percent confidence interval, 1.19 to 2.52] in men and 2.12 [95 percent confidence interval, 1.28 to 3.49] in women). Left ventricular mass (corrected for height) was associated with death from all causes (relative risk, 1.49 [95 percent confidence interval, 1.14 to 1.94] in men and 2.01 [95 percent confidence interval, 1.44 to 2.81] in women). We conclude that the estimation of left ventricular mass by echocardiography offers prognostic information beyond that provided by the evaluation of traditional cardiovascular risk factors. An increase in left ventricular mass predicts a higher incidence of clinical events, including death, attributable to cardiovascular disease.
5,368 citations
Journal Article•
5,203 citations
"Effect of frequent nocturnal hemodi..." refers methods in this paper
...The formula by DuBois and DuBois16 was used to index LV mass to body surface area....
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...Diastolic Baseline 75 (14) 77 (16) −2 (−10 to 7)...
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...Peripheral vascular disease 4 (15) 4 (16)...
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TL;DR: The model presented in this article appears to predict the values of the states for which there are direct observations and, thus, can be used to interpolate values for theStates for which no direct observations exist.
Abstract: OBJECTIVES. It has become increasingly common for preference-based measures of health-related quality of life to be used in the evaluation of different health-care interventions. For one such measure, The EuroQol, designed to be used for these purposes, it was necessary to derive a single index value for each of the 243 health states it generates. The problem was that it was virtually impossible to generate direct valuations for all of these states, and thus it was necessary to find a procedure that allows the valuations of all EuroQol states to be interpolated from direct valuations on a subset of these. METHODS. In a recent study, direct valuations were elicited for 42 EuroQol health states (using the time trade-off method) from a representative sample of the UK population. This article reports on the methodology that was adopted to build up a "tariff" of EuroQol values from this data. RESULTS. A parsimonious model that fits the data well was defined as one in which valuations were explained in terms of the level of severity associated with each dimension, an intercept associated with any move away from full health, and a term that picked up whether any dimension in the state was at its most severe level. CONCLUSIONS. The model presented in this article appears to predict the values of the states for which there are direct observations and, thus, can be used to interpolate values for the states for which no direct observations exist.
4,324 citations
TL;DR: There was a high prevalence of CVD in CKD and that mortality due to CVD was 10 to 30 times higher in dialysis patients than in the general population, and the task force recommended that patients with CKD be considered in the “highest risk group” for subsequent CVD events.
Abstract: Chronic kidney disease1 (CKD) is a worldwide public health problem. In the United States, there is a rising incidence and prevalence of kidney failure, with poor outcomes and high cost. The number of individuals with kidney failure treated by dialysis and transplantation exceeded 320 000 in 1998 and is expected to surpass 650 000 by 2010.1,2 There is an even higher prevalence of earlier stages of CKD (Table 1).1,3 Kidney failure requiring treatment with dialysis or transplantation is the most visible outcome of CKD. However, cardiovascular disease (CVD) is also frequently associated with CKD, which is important because individuals with CKD are more likely to die of CVD than to develop kidney failure,4 CVD in CKD is treatable and potentially preventable, and CKD appears to be a risk factor for CVD. In 1998, the National Kidney Foundation (NKF) Task Force on Cardiovascular Disease in Chronic Renal Disease issued a report emphasizing the high risk of CVD in CKD.5 This report showed that there was a high prevalence of CVD in CKD and that mortality due to CVD was 10 to 30 times higher in dialysis patients than in the general population (Figure 1 and Table 2).6–18 The task force recommended that patients with CKD be considered in the “highest risk group” for subsequent CVD events and that treatment recommendations based on CVD risk stratification should take into account the highest-risk status of patients with CKD.
View this table:
TABLE 1. Stages of CKD
Figure 1. Cardiovascular mortality defined by death due to arrhythmias, cardiomyopathy, cardiac arrest, myocardial infarction, atherosclerotic heart disease, and pulmonary edema in general population (GP; National Center for Health Statistics [NCHS] multiple cause of mortality data files International Classification of Diseases, 9th Revision [ICD 9] codes 402, 404, 410 to 414, and …
4,037 citations
Journal Article•
3,516 citations