Japanese Society for Dialysis Therapy Clinical Guideline for “Hemodialysis Initiation for Maintenance Hemodialysis”

Abstract

In Japan, guidelines for initiation of chronic hemodialysis (Health Science Research Guidelines 1), prepared by the Committee of Medical Research Project for Kidney Failure set up by the Japanese Ministry of Welfare in 1991, have been used as a criteria for initiation of dialysis for more than 20 years. Though this guideline is still utilized in the clinical field, the current characteristics of dialysis patients have largely changed compared to those days. Currently, the mean age of dialysis patients is more than 65 years, and patients with systemic vascular complications derived by diabetic nephropathy or nephrosclerosis account for more than 50% of dialysis patients 2. Furthermore, the concept of chronic kidney disease (CKD) has attracted attention worldwide, and there are advances in the standardization of various tests and assessment methods for kidney function. According to these circumstances, new guidelines for hemodialysis initiation have come forth from several other countries. As clinical evidence pertaining to hemodialysis initiation for chronic renal failure has been compiled, there is an increasing demand to reassess these guidelines for dialysis initiation in Japan. On account of this increasing demand, the Japanese Society for Dialysis Therapy (JSDT) has prepared these guidelines with the cooperation of academic societies affiliated with JSDT. Patients subjected to this guideline are those who will be starting chronic hemodialysis as renal replacement therapy. Hemodialysis is a mainstream treatment in Japan, and approximately 95% of patients suffering from terminal renal failure are treated with hemodialysis. Criteria for patients showing acute kidney injury (AKI) including acute exacerbation of chronic renal failure might be applied to the guidelines for AKI 3. In recent years, the number of patients with chronic kidney disease (CKD) has been growing worldwide. There has been a marked increase in patients whose CKD has progressed to terminal chronic renal failure and consequently require renal replacement therapy 4. For this reason, global preventive measures against CKD have been taken proactively by promoting awareness, early detection, and early state of treatment for CKD in order to prevent disease progression 5. The Japanese Society of Nephrology created an eGFR equation on the basis of serum creatinine, age, and gender in order to estimate glomerular filtration rate (GFR) 6. This equation can only be applied to patients over 18 years of age; hence, cases under 18 years of age have been excluded in a survey on hemodialysis initiation conducted by JSDT 7, 8. Therefore, guidelines for pediatric patients are described in a separate chapter in detail. As for patients treated with peritoneal dialysis (PD), we recommend to follow the “JSDT Guideline for Peritoneal Dialysis” 9 in 2009. The patients who need restarting of hemodialysis by functional graft loss after kidney transplantation frequently suffer from patients' psychological issues, side effects associated with immunosuppressive drugs, and so on; therefore, these patients are also excluded from this guidelines 10. Discussion for preemptive kidney transplantation are now going on among Japan Society for Transplantation, Japanese Society for Clinical Renal Transplantation, and Japanese Society for Pediatric Nephrology; thus, these patients are also excluded from this guidelines. Guidelines for initiation of renal replacement therapy encompassing AKI, PD, and renal transplantation need to be clearly laid out in future because the treatment procedures described above are all for replacement therapy for renal disease irrespective of terminal stage or not. The grades of evidence levels and recommendations for clinical practice in these guidelines were determined according to those established by JSDT Assessment Committee on Evidence Levels 11, which were prepared on the basis of the position paper titled “Grading Evidence and Recommendations for Clinical Practice Guidelines in Nephrology” 12. This paper was published in 2006 by KDIGO and it is commonly used around the world for clinical guidelines for renal diseases. Grades for evidence levels are categorized as follows: (A) High, (B) Moderate, (C) Low, and (D) Very Low. It was unanimously decided that the data sampled by Japanese patients would be evaluated by raising the grade by one rank. Recommendations were evaluated on a scale of 1–2 as (1) Strongly Recommended and (2) Moderately Recommended. In this paper, eGFR, mGFR, and GFR are used to represent an estimated GFR (eGFR) using a predictive equation, a measured GFR (mGFR) using collected urine specimen or under the load of some special substance, and a GFR (GFR) indicating renal function in general sense. Serum creatinine levels can be affected by several factors such as increasing muscle mass after exercise, difference in gender, and nutritional conditions; therefore, estimation of renal function by serum creatinine levels alone is inadvisable 13. It has become evident that patients who can await hemodialysis initiation until serum creatinine values reach to a high level are likely to have a potency of secreting creatinine at a high level 14. Therefore, measured Ccr of those patients is contradictory high when compared to the values of eGFR determined by serum creatinine 15. Considering the above evidence, the decision to initiate hemodialysis should not be made solely based on serum creatinine levels. Moreover, the specific serum creatinine levels to decide initiation of hemodialysis cannot be determined at the present time. The relationship between GFR (inulin clearance) and eGFR. Moreover, another method that may be considered to assess the remaining renal function in PD is Kt/V urea nitrogen (UN) per week 22, but it is not commonly employed, where K: efficiency of a dialyzer in removing urea, t: period of dialysis, and V: body water volume. In addition to these methods, clearance of 99mTc-DTPA or dextran is utilized in some countries; however, they are not the prevailing methods in Japan. When prognosis of chronic hemodialysis patients within 1 year after hemodialysis initiation was reviewed, mortality of patients who started hemodialysis with high levels of eGFR has been reported to be high 8, 23-26, and the result is the same in Japan 7. However, it has been reported recently that, by using mGFR obtained from the average of Ccr and Curea as an index of GFR, starting hemodialysis with high values of mGFR does not necessarily reflect an unfavorable prognosis 27. A meta-analysis studying the prognosis of patients based on residual renal function at starting hemodialysis using 15 cohort studies revealed the following results: (i) life expectancy of patients who had been forced to initiate dialysis with high eGFR determined by equation method was not good; (ii) the prognosis of patients whose mGFR was high at hemodialysis initiation was not so bad 28. Thus, there is a discrepancy between eGFR and mGFR at the terminal stage of renal failure. As stated above, precise assessment of renal function at the time of hemodialysis initiation should be made on the basis of GFR obtained from inulin clearance values and second selection might be the average of Ccr and Curea. But, it is not always possible to conduct these measurement methods in all cases at clinical practice. In such cases, confirmation of GFR < 15 mL/min/1.73 m2 by eGFR values should be done, but the judgment from serum creatinine levels alone should not be done. Then, the timing of the initiation should be comprehensively assessed on the basis of chronological changes in levels of serum creatinine and eGFR over time, body weight, urine volume, uremic symptoms, and other factors. In the event that terminal renal failure is anticipated in the near future, the following is recommended: 1) A satisfactory explanation regarding renal RRT should be provided to the patient and his/her family, and their consent should be obtained for the same; and 2) an opportunity should be provided to the patient to make his/her selection to receive optimum RRT. Prospective study evaluating the timing for starting explanation of RRT has not been studied at present. However, it is considered appropriate to start explanation when renal function deteriorates to the levels around 30 L/min/1.73 m2 by eGFR 29. It is further recommended to provide thorough medical management and lifestyle guidance/dietary instructions or educational intervention to prevent further progression of renal failure; efforts must be made to delay hemodialysis initiation as much as possible. Furthermore, it is necessary to consider the timing and context of explanation of RRT evaluating with not only laboratory data but also the following conditions: the patient's original disease, social background such as age and personality of the patient, and the rate of deterioration of renal function. It is recommended that the patient will be referred to a nephrologist when GFR reaches less than 50 mL/min/1.73 m2 from the aspect of preventing CKD progression as well as educational intervention, and consequently he/she will be treated in collaboration with a nephrologist. However, for patients under 40 years of age, a referral to a specialist should be considered sooner, when a GFR < 60 mL/min/1.73 m2 is reached; for those 70 years of age and over, a GFR < 40 mL/min/1.73 m2 may be acceptable for specialist referral 30. Educational intervention in a chronic renal failure patient and his/her family during the conservative period helps delay hemodialysis initiation and improve life prognosis of the patient after initiation 31, 32. Outside Japan, evidence shows that early referral (ER) rather than late referral (LR) to a nephrologist can provide better blood and which the and progression of renal and to a better life prognosis after hemodialysis initiation However, the of from 1 to 1 year to the initiation from Moreover, can the of at the time of initiation and have effects on the of life and after hemodialysis initiation a study conducted with patients who were than years of age reported that the difference of medical by nephrologist at stage by less or more not the life expectancy after hemodialysis initiation complications frequently in patients might have a on further are in Japan have that patients who a medical for or more at stage had a rate after dialysis initiation compared to less than A survey conducted by JSDT on patients who started dialysis also revealed that for or more at stage at the time of 1 year after dialysis initiation than the patients who had a referral to a specialist only 1 The of was in the cases with a period of and was with a period of showing 7. Patients with renal function should be by a nephrologist in collaboration with a in with the CKD guidelines because it is not for to provide all patients with such medical According to this concept and a study conducted by JSDT above, the in this guideline is as follows: with renal function are to be treated and up with collaboration of nephrologist for over to initiation of hemodialysis to prevent the of renal failure vascular appropriate selection of according to patient's of side to make and assessment for function after are In the to and for published by JSDT in it is recommended that the timing for of on residual renal function as eGFR 15 mL/min/1.73 m2 the of with renal failure. Furthermore, it is stated in these guidelines that and should be created at and to the dialysis The Kidney guidelines recommend or at a to the initiation of dialysis It has been reported that, compared to for the of by of dialysis the prognosis after hemodialysis initiation and However, one study reported that the to hemodialysis by a of life expectancy after hemodialysis initiation compared to the of at the timing of CKD stage and it that early is not A survey conducted by JSDT that had been created to dialysis initiation in cases where within 1 year after the it had been created to the initiation in cases that 7. of the in cases where had been created to initiation of dialysis as compared with those that had been created 1 to the initiation including on the initiation The within a for patients whose was created 1 to initiation was it was in cases where had been created to the initiation it is recommended that be created at 1 to dialysis initiation from the of the patient's on hemodialysis The specific time to should be determined factors such as patient's age, original renal rate of deterioration of renal or of and the of It has been reported that, in an there were in of blood and prognosis after hemodialysis initiation compared with those of an in the clinical that had not been created to hemodialysis initiation On the the patients who in educational at the stage and a RRT were likely to have in high rate at start of and the life expectancy within of hemodialysis initiation was on these of educational patients can and dialysis initiation is and a relationship with who can is to at an appropriate time. The renal function of patients at the time of dialysis initiation in Japan was reported as a mean eGFR of mL/min/1.73 m2 between and and it to mL/min/1.73 m2 in however, the of patients who for an eGFR mL/min/1.73 m2 was only 7, In a starting hemodialysis using eGFR as the renal function index is a recent in the and The guidelines for hemodialysis initiation were in these of those recommend starting hemodialysis at mL/min/1.73 m2 using the eGFR as a of renal failure are When these become to with initiation of hemodialysis must be in including renal function. According to the data of JSDT in the of renal failure at the time of initiation were and failure The relationship between patients' and the that was the of hemodialysis initiation was studied among those who were in as It that of and and a high of that these are factors for dialysis is another to decide hemodialysis of has a with recent advances in however, the progression of as a of uremic is also a to decide for hemodialysis in life should also be considered as for dialysis nutritional is an for initiation of hemodialysis. It is recommended that nutritional assessment is global assessment and body serum and rate comprehensively But, to decide specific or values for a for hemodialysis further are necessary It has been out that early initiation of dialysis may prevent complications to thus, improve this in the guidelines eGFR mL/min/1.73 m2 was to be a dialysis initiation which was to 15 mL/min/1.73 m2 in the 2006 that the of early hemodialysis initiation still under the number of patients starting hemodialysis with eGFR mL/min/1.73 m2 is increasing year in the However, complications with hemodialysis might be likely to with early Furthermore, a a lifestyle as well as an increase in medical are from early initiation of Patients who need hemodialysis with high eGFR levels are to have more and this is the they are from early hemodialysis initiation life prognosis of those who started hemodialysis with high eGFR levels was reported in nephropathy patients complications As a result of the recent studies have reported that early dialysis initiation at a high GFR stage may result in life prognosis these data have been A meta-analysis of 15 studies conducted by that with increase in eGFR of 1 mL/min/1.73 m2 at the time of was < and high mortality was with an increase in eGFR meta-analysis of studies including the study that the of early initiation all was the of urine volume, a of the study in the revealed a between residual urine 1 year after dialysis initiation and a prognosis as study were conducted in and to dialysis initiation timing on the basis of eGFR A of patients at CKD stage in this study and were an early initiation in which the hemodialysis was started with an eGFR at mL/min/1.73 and a late initiation in which the dialysis was started with an eGFR at mL/min/1.73 This study was with a of years of There are to be considered when it to that hemodialysis was started in of the patients in the late initiation eGFR of mL/min/1.73 However, there was difference between the pertaining to including patients' mortality also revealed that medical were in the early initiation and prognosis with was not Thus, the study data that hemodialysis can be until eGFR reaches mL/min/1.73 m2 are not It is that dialysis initiation can be well by conservative study reported from that out of 30 CKD stage patients whose eGFR had mL/min/1.73 m2 their life hemodialysis for approximately 1 year with eGFR around mL/min/1.73 patients hemodialysis initiation In another were one in which CKD patients with eGFR of mL/min/1.73 m2 were on and the other in which patients were provided with a of and hemodialysis. The was to dialysis by a of was mL/min/1.73 m2 at the time of dialysis There was difference in life between the the in which dialysis was had a rate 95% these studies with only they that hemodialysis initiation can be by an appropriate conservative treatment at from JSDT that the the eGFR at the time of hemodialysis the better the life prognosis after the initiation effects of complications cannot be Therefore, in a survey of patients for hemodialysis had been started in various at the time of initiation were using the index as a and life by eGFR were The data that the mortality of patients' hemodialysis initiation with eGFR < mL/min/1.73 m2 was than that of patients with eGFR of mL/min/1.73 m2 7, prognosis after hemodialysis initiation with several was the same when patients with eGFR levels of mL/min/1.73 m2 were by of mL/min/1.73 m2 7. Therefore, from the of initiation life hemodialysis initiation should be until GFR less than mL/min/1.73 m2 as as the patient's of renal failure are it is at in of residual renal that hemodialysis initiation with GFR < mL/min/1.73 m2 to a life the same time, life prognosis was when there was of According to from JSDT in and the mean eGFR of patients of patients was mL/min/1.73 and a among these patients revealed that the mortality of patients who started hemodialysis with eGFR mL/min/1.73 m2 was compared to that with eGFR of mL/min/1.73 with age, gender, and disease, patients who started hemodialysis with eGFR mL/min/1.73 m2 high than those who started with eGFR mL/min/1.73 m2 8. there is specific GFR level for patients that can be recommended to initiate dialysis with it is recommended to initiate hemodialysis when GFR reaches mL/min/1.73 m2 there is of using a measured Peritoneal dialysis initiation there is still some residual renal function of symptoms, and the recommended GFR level for starting peritoneal dialysis is approximately mL/min/1.73 As for preemptive kidney it under general therefore, it should be at a more early stage of CKD compared to peritoneal hemodialysis is not so much on residual urine compared with peritoneal dialysis, hemodialysis initiation is considered at a stage of CKD when renal failure become to Thus, the optimum timing of dialysis initiation may the selection of treatment The timing of dialysis initiation is determined not on the basis of eGFR or serum creatinine but on assessment of renal function such as a measured GFR over time or a of of renal failure As in renal function is determined to have an eGFR < 15 mL/min/1.73 RRT initiation should be considered a in renal function increase in serum creatinine over is conservative of RRT initiation timing and residual renal function. for initiation of hemodialysis. management by from of uremic or uremic GFR, glomerular filtration after the initiation of hemodialysis has been reported in number of cases in the of JSDT and hemodialysis was for some patients because of systemic from hemodialysis his/her is frequently in the In the patients who acute exacerbation on chronic renal failure can from hemodialysis after the of exacerbation The of after from and have not been evaluated so Therefore, after the initiation of it is necessary to the patients at all to or not dialysis treatment can be because the patient life and medical There are the of from hemodialysis to time is appropriate for The of hemodialysis should be determined from the of body and and on the management of body water dialysis in some from hemodialysis may be possible. On the other the of has been stated for in acute kidney injury It is recommended that from hemodialysis be in the patients who the of serum and increase in Ccr of 20 mL/min/1.73 m2 or under RRT from the studies of this cannot be for chronic however, it may be for the of in CKD treatment are as follows: 1) of renal failure 2) of which is a in pediatric of of associated with life and of renal failure to when GFR 60 mL/min/1.73 and such as and disease, age of renal failure and and are in this Therefore, for is to be made by a pediatric nephrologist and treatment for Furthermore, serum level to in early CKD stage levels of start to GFR 30 mL/min/1.73 serum levels to and also The concept of vascular and life prognosis in and treatment can be applied to as well as In of and levels in is in of of as well as preventive therapy for For that reason, an appropriate treatment is to be by a pediatric nephrologist at an early stage of CKD in a where a pediatric nephrologist with renal failure treatment provided a at CKD with until RRT was it was that the of renal serum serum serum serum and dialysis initiation were well however, only of patients at a stage when GFR 20 mL/min/1.73 m2 are referred to a and of the referred patients are forced to initiate RRT within 1 after the referral with a pediatric nephrologist to be in clinical practice. there are several specific to that need attention RRT when the GFR to approximately 30 mL/min/1.73 and the progression to terminal renal failure in the future is to be a nephrologist with peritoneal dialysis, and kidney is RRT may be after a patient and his/her family are a thorough explanation regarding and of the of RRT dialysis, and renal and they have the there is to the of treatment is made based on the of the pediatric patient and his/her family and or not an is present. RRT initiation may not be a of treatment the patient's such as or complications other than renal Therefore, should be according to the published by JSDT pertaining to chronic hemodialysis therapy initiation and of the therapy for terminal patients hemodialysis is a the of is hemodialysis is to for an period of time than a year as a it is recommended that be created However, is hemodialysis is not recommended for a pediatric patient, because blood are so that it is to is it may the blood which may make the in life when it is this must be In it is recommended that the blood be at to and the patient at 20 it several to for to in cases, the to be prepared well in Furthermore, in the event that it is decided to an it is necessary to consider the blood on the side of the In in with a body less than 20 or with such as and in an is a can be used In the event that hemodialysis using the is the of the should be A including the possible to peritoneal dialysis or renal in is also Considering the future of or renal it is recommended to a the or as much as possible to the procedures and in it is to to the for and of for the Japanese Society for Dialysis Therapy associated with the of a and injury are the is there is of and There are criteria for dialysis initiation based on guidelines recommend that dialysis be of renal failure during conservative medical management GFR 15 mL/min/1.73 In according to the data of cases reported from the and where RRT was between and of the cases were on dialysis when GFR 15 mL/min/1.73 m2 Furthermore, pediatric of to or after dialysis initiation using GFR values with GFR 15 mL/min/1.73 m2 and the other with GFR 15 mL/min/1.73 revealed that the with the GFR at the time of initiation had a after RRT initiation than the with the there are criteria for dialysis thus, it is appropriate that dialysis initiation be determined by comprehensively of renal failure during conservative medical management symptoms, renal loss of or the of in life in to or On the other there are also guidelines that recommend dialysis initiation be considered GFR reaches mL/min/1.73 m2 or when GFR reaches mL/min/1.73 m2 the is According to a study on the timing of RRT initiation in renal and cases are the cases among of pediatric terminal renal serum and levels were well and the was when the GFR progressed to mL/min/1.73 acute and a number of patients to dialysis Therefore, it to consider initiation of dialysis in pediatric patients the is Dialysis may be started when GFR mL/min/1.73 However, in cases of renal failure symptoms, the medical evidence is not to the criteria for dialysis initiation solely from the of renal thus, this of dialysis initiation criteria to be further of The JSDT has been the to and of for there to be a and of guideline In the JSDT a new for to of of JSDT guideline are now to provide to state or of are or an is by of has from and has and from and has from and has from has from has and from and has from and Japan has and from and and to at has and from and Japan has from and has and from Japan and Medical has and from and has and from and has from and has and from and has from Medical and has to social and from Japan Japan and has from and other the of of