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Indications for initiation of dialysis in chronic kidney disease

Author Nuhad Ismail, MD Section Editors Steve J Schwab, MD Jeffrey S Berns, MD Deputy Editor Theodore W Post, MD

Last literature review version 19.1: January 2011 | 2010 (More)

This topic last updated: October 5,

INTRODUCTION The decision to initiate dialysis in a patient with chronic kidney disease (CKD) involves the consideration of subjective and objective parameters by the physician and the patient. These parameters are often modulated by the patient's perception of his or her quality of life and by possible anxiety about starting new therapy that is technologically complex. INDICATIONS There are a number of clinical indications to initiate dialysis in patients with CKD. These include [ 1-3 ]: Pericarditis or pleuritis (urgent indication) Progressive uremic encephalopathy or neuropathy, with signs such as confusion, asterixis, myoclonus, wrist or foot drop, or, in severe cases, seizures (urgent indication) A clinically significant bleeding diathesis attributable to uremia (urgent indication) Fluid overload refractory to diuretics Hypertension poorly responsive to antihypertensive medications Persistent metabolic disturbances that are refractory to medical therapy; these include hyperkalemia, metabolic acidosis, hypercalcemia, hypocalcemia, and hyperphosphatemia Persistent nausea and vomiting Evidence of malnutrition However, these indications are potentially life-threatening and the patient is generally known to have advanced CKD. As a result, most nephrologists agree that delaying initiation of dialysis until one or more of these complications is present may put the patient at unnecessary jeopardy. Only one study has reported the outcomes of patients with CKD who initiated dialysis only after the onset of symptoms due to uremia. In this prospective cohort study of 233 consecutive patients with advanced uremia, 151 were elective starters on dialysis, while 82 initially declined dialysis [ 4]. Among the initial refusers, 55 percent developed a uremic emergency, while 48 percent were eventually established on maintenance dialysis. Compared with the elective starters, one year mortality was significantly higher among the initial refusers (18 versus 7 percent). However, these results are confounded by lack of randomization and by three deaths among the initial refusers, which resulted from treatment withdrawal.

Relative indications Since an important goal of dialysis is to enhance the quality of life as well as to prolong survival, it is therefore important to consider less acute indications for dialysis. These relative indications include decreased attentiveness and cognitive tasking, depression, persistent pruritus or the restless leg syndrome. Unfortunately, the expressions of these signs and symptoms are variable in patients with slowly progressive renal disease. The following are some of the factors that may contribute to this variability. Some patients accommodate to these symptoms and downgrade their sense of wellbeing as renal failure progresses. Many of the medications given to patients with CKD have side effects that mimic uremic symptoms. As examples, oral iron therapy often leads to nausea and centrally-acting antihypertensive drugs can induce drowsiness independent of the degree of renal failure. These factors illustrate the need to identify more objective markers of renal failure to lessen the subjective component of the decision to initiate dialysis. QUANTITATIVE MEASUREMENTS OF END-STAGE RENAL DISEASE The two most widely evaluated quantitative measurements of end-stage renal disease have been estimation of the glomerular filtration rate (GFR) and assessment of nutritional status. Estimation of GFR Although the filtration rate provides the best measure of functioning renal mass, there are problems with each of the available tests used to measure the GFR. As an example, many nephrologists previously used a target plasma creatinine concentration above 10 mg/dL (884 mol/L) [ 5,6 ]. However, progressive renal failure is frequently associated with marked changes in the generation and elimination of creatinine [ 7]. In particular, inadequate diet, increased tubular secretion of creatinine, and low muscle mass often limit the rise in the plasma creatinine concentration, thereby masking the true degree of renal failure. Use of the creatinine clearance is also limited in this setting. (See "Calculation of the creatinine clearance" .) The creatinine clearance generally overestimates the GFR due to increased tubular creatinine secretion. Some patients with a seemingly "normal" plasma creatinine concentration (<1.5 mg/dL or 132 mol/L) may have a GFR determined by 7]. One study, for example, inulin clearance as low as 20 to 25 mL/min/1.73 m [ evaluated 80 patients with CKD and a mean GFR of 22 mL/min [ 8]. The creatinine clearance was nearly twice the level of the inulin clearance. The urea clearance is an even less accurate measure of GFR. The urea clearance underestimates the rate of filtration due to a substantial degree of tubular reabsorption. It has been suggested that, when GFR is less than 15 mL/min, the mean of the creatinine and urea clearance provides a good estimate of GFR because the errors balance out. (See "Assessment of kidney function: Serum creatinine; BUN; and GFR" Because of the limitations of the conventionally used tests, many investigators have sought more accurate methods to measure the GFR. Although other markers of GFR, such as the clearance of 125-I-iothalamate, Cr-51-EDTA, 99m-Tc-DTPA, or inulin, are considered to be highly accurate, they are not widely available and cumbersome to use for regular monitoring of renal function. Several formulas that utilize easily obtained values have therefore been developed that

.)

help estimate the GFR. These include the Cockcroft-Gault and Modification of Diet in Renal Disease (MDRD) equations: The Cockcroft-Gault equation is: (140 - age) x lean body weight [kg] PCr [mg/dL] x 72

CCr, in mL/min

This formula takes into account the increase in creatinine production with increasing weight, and the decline in creatinine production with age. The value obtained must be calculator 1 ). multiplied by 0.85 in women who have a smaller muscle mass than men ( Using data from the MDRD study, the following is a simplified MDRD formula [ GFR, in mL/min per 1.73 m2 = 186.3 x ((serum creatinine) exp[-1.154]) x (Age exp[-0.203]) x (0.742 if female) x (1.21 if African American) where exp is the exponential. The K/DOQI clinical practice guidelines for CKD, as well as other K/DOQI guidelines, can be accessed through the National Kidney Foundation's web site at www.kidney.org/professionals/kdoqi/guidelines.cfm . Since the MDRD equations were derived from patients with renal failure, they can be reliably used in those with significant renal dysfunction. The MDRD and Cockroft-Gault equations, however, appear to generally overestimate the GFR in patients with stage 4 and 5 disease. Both the abbreviated MDRD formula and the Cockcroft-Gault equations provide similar values within a wide-range of patient ages. These formulas can only be used in patients with stable renal function. A detailed discussion of these formulas can be found elsewhere. (See "Assessment of kidney function: Serum creatinine; BUN; and GFR" .) A retrospective study in the United States found that the GFR at initiation of dialysis varied with patient age [ 10 ]. Based upon the United States Renal Data Systems database from 1995 to 1999, the creatinine clearance at initiation was 14.76, 13.38, 11.63, and 11.60 mL/min among those aged 20 to 44, 45 to 64, 65 to 74, and greater than 75 years, respectively. Nutritional status Many studies have shown an increased mortality risk associated with malnutrition in patients on maintenance dialysis [ 11,12 ]. As an example, an inverse relationship has been shown between the plasma albumin concentration and mortality risk in this setting [ 13,14 ]. The risk of death is increased when the plasma albumin concentration is below 3.5 to 4 mg/dL (35 to 40 g/L) ( figure 1 ). (See "Patient survival and maintenance dialysis" .) The United States Renal Data Systems analysis extended this observation by evaluating the relationship between the plasma albumin concentration at the time of initiation of dialysis and subsequent survival [ 14 ]. The risk of death in patients starting hemodialysis with hypoalbuminemia was substantially higher than in patients with a normal plasma albumin concentration ( figure 2 ). This relationship persisted even when diabetic patients, who may have significant proteinuria, were excluded from the analysis [ 15 ]. Worse outcomes in patients with lower plasma albumin concentrations at the initiation of dialysis 9]:

have also been noted in patients with continuous peritoneal dialysis [

16 ].

The significance of hypoalbuminemia in patients with nephrotic syndrome (other than diabetes) and end-stage renal disease is undetermined at present. In this setting, the low plasma albumin concentration may not reflect malnutrition. When interpreting the plasma albumin concentration, it is important to be aware of the specific assay used by the clinical laboratory. The two most commonly used methods are the bromcresol green (BCG) and bromcresol purple (BCP) dyebinding methods. BCG binds other proteins and therefore overestimates the albumin concentration. This error does not occur with the BCP method, the results of which compare closely with the reference immunonephelometric method [ 17,18 ]. Another marker of nutritional status at the time of dialysis initiation is the plasma creatinine concentration. The creatinine level reflects muscle mass as well as renal function. Thus, a patient requiring dialysis at a lower than usual plasma creatinine concentration has a reduced muscle mass and may be malnourished. Data from the USRDS are consistent with this hypothesis as the late mortality rate was increased in patients with a plasma creatinine concentration below 10 mg/dL (884 mol/L) at the start of dialysis ( figure 2 ) [ 14 ]. In comparison, the BUN level did not show a correlation with mortality risk. These data strongly suggest that malnutrition, as evidenced by a low plasma albumin and/or creatinine concentration at initiation of dialysis for symptomatic uremia, is an important prognostic variable. Other markers of malnutrition also may prove useful, including the plasma concentrations of transferrin, somatomedin C, prealbumin, and .) In cholesterol [ 19 ]. (See "Assessment of nutritional status in end-stage renal disease" patients treated with CAPD, for example, low serum prealbumin concentrations (<30 20 ]. A similar finding has mg/dL) have been associated with increased mortality risk [ been shown with maintenance hemodialysis (relative risk of mortality was 4.4 when the plasma prealbumin concentration was less than 15 mg/dL) [ 9]. A simple determinant of nutritional status that can be easily monitored is protein intake, assuming that the patient is not on a low protein diet. Patients with CKD on an unrestricted diet tend to decrease their protein intake as the renal failure progresses. The magnitude of this effect was demonstrated in a report that evaluated 90 patients with 21-23 ]. A direct correlation was noted between CKD who received no dietary intervention [ the dietary protein intake and the creatinine clearance (Ccr): 1.1 g/kg per day at a Ccr above 50 mL/min 0.85 g/kg per day between 25 and 50 mL/min 0.70 g/kg per day between 10 and 25 mL/min 0.54 g/kg per day below 10 mL/min These changes, which presumably reflect anorexia induced by renal failure, question the safety of restricting protein intake in patients with a creatinine clearance below 25 mL/min. These decrements in dietary protein intake can be followed by assessing daily urinary urea nitrogen and nonurea nitrogen losses. If daily intake is relatively constant and the patient is in a steady state (as evidenced by a stable BUN and body weight), then urinary nitrogen excretion is roughly equal to nitrogen intake. The former can be estimated from [24 ]: Urinary nitrogen excretion = Urine urea nitrogen + Nonurea nitrogen

Nonurea nitrogen excretion is relatively constant, averaging 30 mg/kg per day. Each gram of nitrogen is derived from 6.25 grams of protein. Thus, Estimated protein intake = 6.25 (Urine urea nitrogen + 30 mg/kg)

If, for example, 24-hour urine urea nitrogen excretion is 8.2 grams in a 60 kg woman excreting 3.5 g of protein per day, then: Estimated protein intake = 6.25 (8.2 + 1.8) = 62.5 grams

Thus, protein intake is approximately 1 g/kg per day. Moderate urinary protein loss can be ignored, but each gram excreted above 5 g/day should be added to the above formula. A useful measurement of protein metabolism is the protein equivalent of nitrogen appearance (eg, excretion) normalized using the ideal body weight (nPNA) which is equivalent to the normalized protein catabolic rate. Values below 0.8 g/kg per day are considered indicative of a malnourished state. (See "Protein catabolic rate in maintenance dialysis" .) Effect of dialysis Although the initiation of dialysis improves appetite in symptomatic uremia, there is a paucity of data showing that it is clearly associated with an improvement in nutritional status. Two observational studies reported that initiation of dialysis was associated with clear improvement in nutritional indices: Over a one year period, different nutritional indices were evaluated every three 25 ]. Marked months after dialysis initiation among 50 hemodialysis patients [ improvements were observed in the serum albumin, serum prealbumin, nPNA, fat mass, and others. The degree of improvement was dependent upon nutrition at baseline, with the lower the baseline value the lower its value at one year. Among 97 patients initiating maintenance dialysis therapy, multiple nutritional indices, including predialysis serum albumin, iron, transferrin saturation, creatinine, and the nPNA, significantly increased over the first six months of therapy, with many 26 ]. In addition, dietary intake, as shown indices continuing to increase at study end [ by the nPNA, directly correlated with serum albumin value. Given that dialysis was initiated based upon varying criteria, these two studies do not address the question of whether early or late initiation of dialysis is optimal. However, these results support the view that dialysis initiation improves nutritional parameters in the first year after beginning renal replacement therapy. DOES EARLY DIALYSIS OR REFERRAL IMPROVE SURVIVAL/OUTCOMES? Survival and dialysis complications There is conflicting evidence concerning the effect of the early initiation of dialysis on survival. Some retrospective and uncontrolled prospective studies have reported no survival benefits with early dialysis while others have 27-31 ]. found such benefits with early initiation [ The only randomized controlled trial that examined mortality and time of dialysis initiation, the IDEAL study, found NO difference in survival between early or late initiation of dialysis. In this study, 828 patients with progressive CKD and an estimated GFR between 10.0 and 15.0 mL/min per 1.73 m2 (as determined by the Cockcroft-Gault equation) were randomly assigned to dialysis initiation when the estimated GFR was either 10 to 14 mL/min per 1.73 m2 or 5 to 7 mL/min per 1.73 m2 [ 32 ]. The median

time to the initiation of dialysis was 1.8 and 7.4 months in the early and late start groups, respectively. At a median followup period of 3.6 years, the two groups had no significant difference in survival (38 and 37 percent mortality, hazard ratio of 1.05 with early initiation, 95% CI of 0.83 to 1.30) as well as no difference in cardiovascular events, infections, or dialysis complications. However, these results do NOT imply that the initiation of dialysis can be delayed until the GFR is between 5 to 7 mL/min per 1.73 m2 in all patients. The design of the IDEAL study permitted clinicians to initiate dialysis based upon the presence of symptoms due to uremia (such as uremic symptoms, volume overload, and other features) as well as on the estimated GFR. As a result, 76 percent of patients assigned to the late start arm initiated dialysis when the GFR was much greater than 5 to 7 mL/min per 1.73 m2. This resulted in a mean GFR of 9.8 mL/min per 1.73 m2 at the start of dialysis for the late start group, which was only 2.2 mL/min per 1.73 m2 less than the mean start GFR for the early group (12.0 mL/min per 1.72 m2). Thus, approximately 88 percent of all enrolled patients had initiated dialysis with an estimated GFR of approximately 10 mL/min per 1.73 m2 or more, either because of symptoms or enrollment in the early dialysis arm. An accompanying editorial to the IDEAL study stated that the results of this trial largely supports current practice that dialysis initiation should be based upon clinical factors 33 ]. Patients with progressive CKD require close rather than the estimated GFR alone [ followup, early nephrology referral, and adequate advance dialysis planning (including the presence of a functioning peritoneal or vascular access and referral for transplantation). In this study, for example, patients were followed by a nephrologist for approximately 2.5 years before dialysis was initiated. We suggest that, among patients with progressive CKD, clinicians must be vigilant for the presence of symptoms and/or signs of uremia and patients should also be fully informed of any symptoms of uremia to be able to contact their physicians appropriately. Dialysis should be considered based upon clinical factors plus the estimated GFR. Dialysis should be initiated in the patient with symptoms and/or signs due to uremia. (See 'Indications' above and 'Summary and recommendations' below and 'Relative indications' above.) Among asymptomatic patients with progressive CKD, the timing of initiation of dialysis is unclear and there is no specific threshold GFR level that has been established for the initiation of dialysis. To help avoid the onset of possible life-threatening complications of uremia, the initiation of dialysis should be considered in the asymptomatic patient with an extremely low GFR, such as an estimated GFR of approximately 8 to 10 mL/min per 1.73 m2. However, some clinicians may choose to closely monitor (weekly) asymptomatic patients with progressive CKD even when GFR is below this level, with the initiation of dialysis upon the onset of uremic signs/symptoms. Nevertheless, as noted in the IDEAL trial, the vast majority of patients are initiated on dialysis because of the onset of uremic symptoms at a GFR of approximately 10 mL/min per 1.73 m2 or above. The following are some of the more recent National and International Guidelines for the initiation of dialysis, which were published before the results of the IDEAL trial were reported: The 2006 National Kidney Foundation Dialysis Outcomes Quality Initiative (K/DOQI) for peritoneal dialysis and hemodialysis adequacy published guidelines concerning the initiation of dialysis among patients with renal insufficiency [ 2,3 ]. The work group suggested that the benefits and risks of initiating renal replacement therapy should

be considered in patients with GFR less than 15 mL/min per 1.73 m2 (stage 5 chronic kidney disease). Initiation of dialysis prior to stage 5 chronic kidney disease may also be required in patients with certain characteristics and/or complications, such as declining health due to the loss of kidney function. The 2005 European Best Practice Guidelines for peritoneal dialysis suggest that dialysis be initiated before the GFR is less than 6 mL/min per 1.73 m2, with consideration of initiation when the GFR is approximately 8 to 10 mL/min per 1.73 m2 [ 34 ]. There may be two additional advantages to early dialysis: control of hypertension and increased dietary intake [ 31 ]. Reversal of volume overload with dialysis often leads to a reduction in blood pressure, which is typically volume-dependent in CKD. (See "Hypertension in kidney disease" .) Perhaps more important, patients on dialysis patients require at least 1 g/kg of protein per day to replace dialysis losses and maintain nitrogen balance. Thus, early institution of dialysis can allow a more liberal diet in terms of both food and fluid. Possible value of early referral A related issue to the criteria for the initiation of dialysis is the timing of referral of patients with chronic renal failure to a nephrologist. Referral occurs at variable levels of renal function, but often late in the course of progressive renal failure, just before or even after the onset of symptomatic uremia. Late referral reflects in part the absence of clear criteria for the initiation of dialysis. However, early referral affords the opportunity to assess the rate of progression of renal disease, to exclude any reversible causes of a declining GFR, and to permit close followup and adequate advance dialysis planning. It may also improve patient outcomes. This is discussed in detail separately. (See "Late referral to nephrologists of patients with chronic kidney disease" .) INITIATION OF DIALYSIS AND DIALYSIS DISEQUILIBRIUM An important potential complication of the initiation of dialysis is the dialysis disequilibrium syndrome. This disorder, which appears to be related in part to a rapid reduction in the plasma osmolality due to urea removal, can produce a variety of symptoms including headache, nausea, vomiting, blurring of vision, muscle twitching, disorientation, tremor, and seizures. Patients with underlying neurologic disease or marked azotemia are at increased risk. .) (See "Dialysis disequilibrium syndrome" INFORMATION FOR PATIENTS Educational materials on this topic are available for patients. (See "Patient information: Dialysis or kidney transplantation which is right for me?" and "Patient information: Hemodialysis" and "Patient information: Peritoneal dialysis" .) We encourage you to print or e-mail these topic reviews, or to refer patients to our public web site, www.uptodate.com/patients , which includes these and other topics. SUMMARY AND RECOMMENDATIONS There are a number of clinical indications to 1-3 ]: initiate dialysis in patients with chronic kidney disease (CKD). These include [ Pericarditis or pleuritis (urgent indication) Progressive uremic encephalopathy or neuropathy, with signs such as confusion, asterixis, myoclonus, wrist or foot drop, or, in severe, cases, seizures (urgent indication) A clinically significant bleeding diathesis attributable to uremia (urgent indication) Fluid overload refractory to diuretics

Hypertension poorly responsive to antihypertensive medications Persistent metabolic disturbances that are refractory to medical therapy. These include hyperkalemia, metabolic acidosis, hypercalcemia, hypocalcemia, and hyperphosphatemia. Persistent nausea and vomiting Evidence of malnutrition Relative indications for the initiation of dialysis include decreased attentiveness and cognitive tasking, depression, persistent pruritus or the restless leg syndrome. We suggest that, among patients with progressive CKD, clinicians must be vigilant for the presence of symptoms and/or signs of uremia and patients should also be fully informed of any symptoms of uremia to be able to contact their physicians appropriately. Dialysis should be considered based upon clinical factors plus the estimated GFR. Dialysis should be initiated in the patient with symptoms and/or signs due to uremia. Among asymptomatic patients with progressive CKD, the timing of initiation of dialysis is unclear and there is no specific threshold GFR level that has been established for the initiation of dialysis. To help avoid the onset of possible life-threatening complications of uremia, the initiation of dialysis should be considered in the asymptomatic patient with an extremely low GFR, such as an estimated GFR of approximately 8 to 10 mL/min per 1.73 m2. However, some clinicians may choose to closely monitor (weekly) asymptomatic patients with progressive CKD even when the GFR is less than 8 to 10 mL/min per 1.73 m2, with the initiation of dialysis upon the onset of uremic signs/symptoms. Nevertheless, as noted in the IDEAL trial, the vast majority of patients are initiated on dialysis because of the onset of uremic symptoms at a GFR of approximately 10 mL/min per 1.73 m2 or above. All approaches require close follow-up, early nephrology referral, and adequate advance dialysis planning (including the presence of a functioning peritoneal or vascular access and referral for transplantation). The following are some of the more recent National and International Guidelines for the initiation of dialysis, which were published before the results of the IDEAL trial were reported: The 2006 National Kidney Foundation Dialysis Outcomes Quality Initiative (K/DOQI) for peritoneal dialysis and hemodialysis adequacy published guidelines concerning 2,3 ]. The work group the initiation of dialysis among patients with renal insufficiency [ suggested that the benefits and risks of initiating renal replacement therapy should be considered in patients with GFR less than 15 mL/min per 1.73 m2 (stage 5 chronic kidney disease). Initiation of dialysis prior to stage 5 chronic kidney disease may also be required in patients with certain characteristics and/or complications, such as declining health due to the loss of kidney function. The 2005 European Best Practice Guidelines for peritoneal dialysis suggest that dialysis be initiated before the GFR is less than 6 mL/min per 1.73 m2, with consideration of initiation when the GFR is approximately 8 to 10 mL/min per 1.73 m2 [ 34 ]. Use of UpToDate is subject to the Subscription and License Agreement

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32. 33. 34.

GRAPHICS

Hypoalbuminemia and reduced survival in hemodialysis

Odds ratio for death, adjusted for age, sex, race, and underlying disease, according to the plasma albumin concentration in patients on maintenance hemodialysis. The likelihood of dying was inversely related to the plasma albumin concentration, being greatest at a plasma albumin concentration below 3.0 g/dL (30 g/L). All values are signficantly different (p<0.001 to 0.03) from the odds ratio of 1.0 at a normal plasma albumin concentration of 4.0 to 4.4 g/dL (40 to 44 g/L).

albumin concentration of 4.0 to 4.4 g/dL (40 to 44 g/L). Data from Owen, WF Jr, Lew, NL, Liu, Y, et al, N Engl J Med 1993; 329:1001.

Nutritional parameters predict relative mortality risk at initiation of dialysis

Relative mortality risk in new patients begun on maintenance hemodialysis in 1986-1987 according to the plasma albumin (left) and creatinine (right) concentrations. The mortality risk varied inversely with both parameters. Asterisks refer to values that are significantly different from the reference ranges of 3.6 to 4.0 g/dL (36 to 40 g/L) for albumin and 10 to 11.9 mg/dL [884 to 1052 mol/L]) for creatinine. Lower albumin and creatinine levels presumably reflect the negative impact of malnutrition on patient survival. Data from United States Renal Data Systems, Am J Kidney Dis 1992; 20(Suppl 2):32.

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