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NDT Advance Access originally published online on April 21, 2006
Nephrology Dialysis Transplantation 2006 21(8):2232-2238; doi:10.1093/ndt/gfl171
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© The Author [2006]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Original Articles: Dialysis and Transplantation

High-efficiency short daily haemodialysis—morbidity and mortality rate in a long-term study

Manuel Carlos Martins Castro, Cláudio Luders, Rosilene Motta Elias, Hugo Abensur and João Egidio Romão Junior

Department of Internal Medicine, Division of Nephrology, Hospital das Clínicas, Faculty of Medicine, University of São Paulo, São Paulo, Brazil

Correspondence and offprint requests to: Manuel Carlos Martins Castro, MD, Hospital das Clínicas da Faculdade de Medicina da USP, Divisão de Nefrologia, Av Dr Enéas Carvalho de Aguiar, 255 7° andar ICHC, sala 7080, CEP 05403-000, São Paulo, Brazil. Email: crica.dialise{at}hcnet.usp.br



   Abstract
Top
 Abstract
Introduction
 Subjects and methods
 Results
 Discussion
 References
 
Background. In conventional haemodialysis (CHD), the morbidity and mortality rate is unacceptably high; consequently, variations in the length and frequency of the haemodialysis sessions have been studied to reduce the complications of dialysis treatment. In this sense, high-efficiency short daily haemodialysis (SDHD) has been proposed as an alternative for patients on renal replacement therapy. In this study, we have related our experience with this dialysis modality.

Methods. Twenty-six patients (16 males, mean age 35.6 ± 14.7 years) were treated by SDHD for 33.6 ± 18.5 months (range 6–57 months). The mean time on CHD before the switch to SDHD was 25.5 ± 31.9 months (range 1–159 months). In 23 (88.5%) patients, native arteriovenous fistulae were used for vascular access. SDHD was performed six times a week, 1.5–2 h per session, and high flux polysulfone dialysers (surface area: 1.8 m2) were employed. The blood flow and dialysate flow rate were 350 and 800 ml/min, respectively.

Results. In this trial, the patient survival was 100%. The vascular access survival after 12, 24, 36 and 48 months on SDHD was 100, 89, 89 and 80%, respectively. There were three failures of vascular access in 72.7 patient-years (0.04 failures/patient-year). In 15 patients on SDHD during 36 consecutive months, the vascular access survival after 12, 24, 36 and 48 months was 100, 93, 93 and 84%, respectively. Also, in this group of patients, there were 0.27 hospitalizations/patient-year and 1.24 days of hospitalizations/patient-year.

Conclusions. We concluded that in a long-time study of patients on SDHD the morbidity and mortality rate is very low. Furthermore, we observed that failures of vascular access are not a significant problem. Consequently, we believe that SDHD is a powerful renal replacement therapy for treatment of patients on maintenance haemodialysis.

Keywords: daily haemodialysis; morbidity; mortality; vascular access



   Introduction
Top
 Abstract
 Introduction
Subjects and methods
 Results
 Discussion
 References
 
Worldwide conventional in-centre haemodialysis three times a week is the renal replacement therapy most frequently used for the treatment of end-stage renal disease (ESRD). Recently, there has been growing interest in haemodialysis techniques that involve variations in the length and frequency of the treatment. In particular, regimens of six to seven sessions per week of haemodialysis have been extensively studied [1–4].

Daily haemodialysis may be performed using either high- or low-efficiency dialysis techniques. In short daily haemodialysis (SDHD), the length of the dialysis sessions range from 1.5 to 2.5 h and a high-flux dialyser is used; on the other hand, in slow nocturnal daily haemodialysis (SNHD), the sessions range from 6 to 8 h with a low-flux dialyser [5]. The SDHD sessions can be carried out in a hospital dialysis facility or in a satellite dialysis unit at a local community hospital, as well as at home. Frequently, SNHD is performed while the patient sleeps at home, and SDHD is carried out predominately in-centre in the USA and Brazil, and at home in Europe.

The rationale for developing techniques that involve variations in dialysis time, frequency and efficiency is based on the need to reduce the high mortality, hospitalization and symptom rates associated with conventional haemodialysis. However, most studies in SDHD were performed in a small number of dialysis centres, and the patients were observed for a very short time. In addition, many patients are not candidates for this high-frequency haemodialysis; thereby resulting in a selection bias that generates confusion in the interpretation of the results.

Most studies in daily haemodialysis have been carried out in developed countries of the northern hemisphere. The only study carried out in a developing country was conducted a long time ago, when modern haemodialysis techniques, which could have provided a significant increase in treatment efficiency, were not available [6]. Therefore, the current data regarding daily haemodialysis do not justify recommending this therapy as safe for treatment of ESRD.

In this study, we describe our experience in a prospective observational study involving in-centre SDHD, conducted at a tertiary-care university hospital, with special focus on long-term evolution.



   Subjects and methods
Top
 Abstract
 Introduction
 Subjects and methods
Results
 Discussion
 References
 
Between 1 April 2000 and 31 December 2004, 26 patients, who had been on conventional haemodialysis (CHD) for at least 1 month, were switched to SDHD. There was no medical indication for SDHD in any case. The patients were informed of the characteristics of the study and adherence was voluntary, motivated primarily by the possibility of improving the quality of life and reducing the intra-dialytic and post-dialytic symptoms, as well as enhancing social and professional rehabilitation. The patients were informed that they could choose to abandon the study at any time, especially if a medical condition arose that would warrant their exclusion. All patients gave informed consent according to the Declaration of Helsinki, and the local Ethical Committee approved the protocol.

SDHD was performed six times a week for 1.5 h per session. Only one patient with diabetes mellitus, ischaemic cardiomyopathy and excessive body weight gain during the inter-dialytic interval was submitted to 2 h of treatment per session.

Before switching to SDHD, comorbidities were evaluated. Patients were categorized as hypertensive if pre-dialysis blood pressure was >140/90 mmHg or if they were currently receiving anti-hypertensive therapy. Those requiring insulin on a daily basis were categorized as diabetic. Heart disease was diagnosed when cardiac insufficiency, associated with fluid overload, or the presence of alterations consistent on echocardiograms were presented. Hyperparathyroidism was diagnosed as parathormone levels >300 pg/ml.

In all SDHD sessions, blood flow rate was 350 ml/min and dialysate flow rate was 800 ml/min. High-flux polysulfone dialysis membranes (Hemoflow HF-80, Fresenius Medical Care, Bad Homburg, Germany) were used, and the reuse was permitted. To prevent clotting in the extracorporeal circuit, heparin 5000 IU, intravenous, in bolus, at the beginning of dialysis was administered. Dialysate composition was: sodium, 138 mEq/l; potassium, 1.0 mEq/l; calcium, 2.5–3.5 mEq/l and bicarbonate buffer, 36 mEq/l. Haemodialysis was performed using the Fresenius 4008 S machine (Fresenius Medical Care, Bad Homburg, Germany).

Staff members evaluated the patients pre-dialysis every day, and biochemical analyses were carried out on a monthly basis. Medical prescriptions were adjusted in order to reach the target suggested by K/DOQI Clinical Practice Guidelines [7–10] and by the Best Practice Guidelines for Dialysis established by the European Dialysis and Transplant Association [11]. The urea kinetic modelling was performed monthly using Daugirdas second-generation equation to estimate single pool Kt/V [12], the Daugirdas–Schneditz rate equation to estimate equilibrated Kt/V [13], and Gotch's recommendation to calculate standard Kt/V [14].

Vascular access failure was defined when SDHD had to be discontinued due to access complications or when a new vascular access was necessary for the maintenance of daily dialysis. We used the term ‘dropout of SDHD’ to describe either a return to CHD or discontinuation of dialysis therapy due to renal transplantation.

For comparison purposes, the 26 patients were divided into two groups: group 1, 11 patients on SDHD for <36 months and group 2, 15 patients on SDHD for ≥36 months. In order to evaluate the long-term effects of SDHD on morbidity and mortality rates, only patients of the group 2 were analysed.

To compare groups 1 and 2, the {chi}2 test with Yates’ correction and Student's t-test were used when indicated. The patients and vascular access survival curves were calculated using the Kaplan–Meier method. Data are expressed as means ± SD. Statistical significance was considered with a P-value < 0.05.



   Results
Top
 Abstract
 Introduction
 Subjects and methods
 Results
Discussion
 References
 
Patients
Figure 1 shows the evolution of the number of patients on SDHD. At the start of the study, four patients became interested in daily haemodialysis therapy. These patients reported great improvement in the intra-dialytic and post-dialytic symptoms, and encouraged other patients to switch to SDHD. After 12 months of SDHD programme, the sample included 14–16 patients per month in this modality of treatment.


Figure 1
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  		Fig. 1. Evolution of the number of patients in the short daily haemodialysis programme at Hospital das Clínicas of the University of São Paulo School of Medicine.

 
Table 1 shows the demographic characteristics of patients on SDHD at study entry. Mean age was 35.6 ± 14.7 years (range 16–64 years), mean body mass index was 21.7 ± 4.8 kg/m2 (range 15.1–32.6 kg/m2) and the time on CHD treatment before being switched to SDHD was 25.1 ± 31.9 months (range 1–159 months). There were no significant differences in these indices when groups 1 and 2 were compared (Table 1).


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  		Table 1. Demographic characteristics of patients on short daily haemodialysis at study entry

 
Table 2 shows the aetiology of the ESRD, the vascular access and the comorbidities present at the start of the study. Glomerulonephritis was the main cause of ESRD among these patients. Eighty-eight percent of patients were using arteriovenous (AV) fistulae for their vascular access, and there were no significant differences between groups 1 and 2. In evaluating comorbidities that could interfere with treatment outcomes, we observed that the prevalence of diabetes and heart disease (15.4 and 7.7%, respectively) was lower than arterial hypertension and hyperparathyroidism (76.9 and 26.9%, respectively). Again, there were no significant differences between groups 1 and 2.


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  		Table 2. A etiology of ESRD, vascular access and comorbidities of patients on SDHD at study entry

 
Vascular access
Figure 2 shows survival curves of patients and vascular access when all patients were analysed together, and Figure 3 shows these curves for patients of group 2. There were no patient deaths during the trial, and the vascular access survival was 80% after 43 months on SDHD, and did not change thereafter.


Figure 2
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  		Fig. 2. Kaplan–Meier survival analysis of patients and vascular access in all patients of the study.

 

Figure 3
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  		Fig. 3. Kaplan–Meier survival analysis of patients and vascular access in patients on short daily haemodialysis more than 36 months.

 
One patient in group 1 with catheter developed an infection in the subcutaneous tunnel after 11 months on SDHD. The catheter was removed, and the vascular access was switched to a short-length synthetic graft with consequent difficulty to rotate needle sites. In this patient, all vascular access sites had been exhausted, and since there were a few data regarding daily haemodialysis in patients using synthetic grafts, the medical staff chose to return the patient to CHD. One patient in group 2 presented a blood flow rate <350 ml/min after 24 months on SDHD and required surgical revision of the vascular access. Another patient in group 2 presented thrombosis of the radial AV fistula after 43 months on SDHD. This patient was switched to CHD using a temporary catheter and later returned to SDHD through a brachial AV fistula. So, in this study, we observed 0.04 failures/patient-year to vascular access.

In one patient in group 2, an AV fistula replaced a catheter after 11 months of treatment on SDHD. This case was not considered a vascular access failure because the catheter worked satisfactorily in SDHD sessions, and the change was performed for the convenience of the patient and the medical staff when the catheter occasionally required thrombolytics to strip fibrin sheaths.

Technique and patient survival
By 31 December 2004, after 57 months of study, 14 patients (53.8%) were on SDHD. The dropout of SDHD was 46.1%. Eleven (42.3%) patients underwent kidney transplantation (positive dropout) and one (3.8%) returned to CHD (negative dropout). Therefore, the mean time on SDHD was 33.6 ± 18.5 months (range, 6–57 months), with a follow-up of 72.7 patient-years.

In this study, 80% of the patients remained on SDHD for at least 12 months; 72% for at least 24 months; 67% for at least 38 months; 50% for at least 48 months and 33% for at least 57 months. SDHD failed in one patient who returned to CHD because of blood access problems. On the other hand, during this study, 11 patients underwent successful kidney transplantation. Of these patients, three (27.3%) were transplanted with a living donor kidney and eight (72.7%) with a cadaver donor kidney. The mean on SDHD therapy before kidney transplantation was 26.4 ± 19 months (range, 6–57 months). Consequently, since only one patient left the SDHD programme due to vascular access complications and excluding renal transplantation dropout, the survival rate of the SDHD technique for treatment of ESRD was 95% after 13 months and remained constant until the study endpoint.

Morbidity
To evaluate the morbidity of long-term SDHD, only patients of group 2 were analysed. Excluding hospital admissions related to vascular access, seven patients (47%) were hospitalized 12 times during the study. One patient had to be hospitalized three times, three patients twice and three patients were hospitalized once each. Three patients had to be hospitalized five times due to cardiovascular complications and two patients were hospitalized for parathyroidectomy. There were two hospital admissions due to nephrectomy, one renal tumour in a native kidney and one removal of renal allograft due to rejection. In addition, three patients were hospitalized for surgical procedures unrelated to renal disease or haemodialysis therapy. There were a total of 56 days of hospitalization, which means 0.27 hospitalizations/patient-year and 1.24 days of hospitalization/patient-year.



   Discussion
Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
References
 
Survival on dialysis therapy correlates with the dialysis dose, and the optimal dialysis dose beyond which there are no further decreases in mortality may not be achievable by CHD. Recently, Haemodialysis (HEMO) study showed that increasing delivered dialysis dose on a thrice-weekly schedule did not improve morbidity and mortality rates, suggesting that improved clinical outcomes may depend on more frequent dialysis [15].

The concept of daily haemodialysis is not new, having been introduced by De Palma more than 25 years ago [16]. A few years later, Bonomini et al. [17] reported six patients who dialysed 3–4 h a day five times per week for 6–12 months. After these initial reports, several papers involving daily haemodialysis as a therapy for ESRD have been published. However, despite the favourable results, there is still little acceptance of this therapy as an alternative to CHD. This low acceptance rate might be the result of uncertainties about vascular access complications, as well as a lack of long-term studies about clinical outcomes of patients. In addition, the number of dialysis centres offering daily haemodialysis therapy is still limited, resulting in multiple publications on single data sets [18–24].

Our results show that SDHD is a safe and an efficient alternative therapy for patients with ESRD on dialysis. This is in accordance with the findings of previous studies on daily haemodialysis [1,24,25]. In this trial, all patients were aware that they could abandon the study at any time; however, none elected to return to CHD. Consequently, the dropout rate of the SDHD technique was quite low. However, in this trial, the number of patients who underwent kidney transplantation was very high, which reduced the mean time on SDHD therapy.

In our programme of SDHD, the length of exposure to haemodialysis therapy was reduced from 12 h per week on CHD to 9 h per week. Although this was done, the long-term morbidity and mortality of the treatment were very low. However, in our study, the mean age of the patients was lower than that reported for patients on CHD. Consequently, this could have contributed to lower morbidity and mortality rates among the patients on SDHD.

Vascular access is critical for the success of SDHD therapy [26–28]. In this trial, a patient was recruited for SDHD only if vascular access provided a blood flow rate of at least 350 ml/min, and whenever the blood flow rate during the haemodialysis session was <350 ml/min, vascular access was immediately revised. Therefore, a bias of selection is possible. However, with high-efficiency dialysis techniques, few dialysis centres currently accept patients with vascular access that provide blood flow rates <350 ml/min.

In our study, the survival of vascular access was 100, 89, 89 and 80% after 12, 24, 36 and 48 months in daily haemodialysis, respectively. This result is very similar to that related to other studies. Quintaliani et al. [26] shows that survival of native AV fistulae was 95 and 80% after 24 and 72 months on SDHD, respectively, and Woods et al. [22] related 93% of survival of AV fistulae after 24 months.

In the present study, AV fistulae were the preferential vascular access for haemodialysis. Since the incidence of complications related to vascular access was very low (0.04 failures/patient-year), our results suggest that AV fistulae are the preferential vascular access for SDHD. Also, Woods et al. [22], in a multicentre study with 72 patients, observed 0.05 failures/patient-year regarding vascular access. Furthermore, in our study, the buttonhole technique [29,30] for cannulation of the AV fistulae was not used; consequently, we concluded that the rotation of the sites of cannulation does not influence AV fistulae outcomes. Together, our observations suggest that vascular access is not a problem in patients on daily haemodialysis for variable lengths of time.

Altogether, our experience with SDHD was very favourable, but the results can be influenced by patients’ selection bias. Our patients tend to be younger, more motivated and have fewer comorbidities. However, we believe that these kinds of patients will be ideal when evaluating a new dialysis therapy; furthermore, in this study, no patient who wished to participate was excluded, and in one patient medical indication for SDHD was presented. Moreover, we believe that younger patients and those who have fewer comorbidities are the ideal candidates for this therapy, because more patients could return to work and the health-related quality of life improved. As a result, this method also greatly enhances social and professional rehabilitation [31,32].

In our unit, in-centre SDHD is performed between 6.30 and 8.30 a.m., therefore increasing the time available for work or study when compared with CHD. Several of our patients go directly from haemodialysis to their place of work. In our opinion, this shows the most important aspect of this modality of treatment: social integration of the patient and very low rates of morbidity and mortality.

Our study was a prospective observation without a control group, so, some comparisons with CHD are difficult. However, our low indexes of mortality and morbidity show that SDHD is a modality of dialysis without additional risks and suitable for widespread, long-term use. As proposed, we are developing a protocol in our centre in which SDHD is proposed as a rescue therapy for weakened patients with a high index of comorbidities. The patients are treated on SDHD until an improvement in clinical conditions; afterwards they are transferred to the CHD regime. However, the patient who is capable of returning to regular work activity is invited to remain in the programme. Then, future studies may find a bimodal patient distribution, with both very low and very high comorbidity groups represented in SDHD programmes.

Our study was not designed to compare the costs of in-centre CHD to in-centre SDHD; however, some comparisons can be performed. In our country, dialysers can be used up to 13 times; consequently, the mean of consumption is one dialyser for a patient-month in CHD, and two dialysers for a patient-month in SDHD. In SDHD, the monthly dialysate spent is 20% more than in CHD, and the expense of reuse is twice as high as in CHD. According to proportionality of costs of each material in our country, the monthly expense is ~70% greater in SDHD.

In our study, to evaluate the cost of medication in CHD and SDHD, each patient served as his or her own control, so case-mix bias was minimized. In this way, we observed a decrease of 60% in monthly expenses for anti-hypertensive drugs. The expense of recombinant human erythropoietin and intravenous iron supplementation was the same in both CHD and SDHD, but the expense of phosphate binders increased by 40%. In the end, when we compared medications in CHD and SDHD, the expense was not different. Finally, once our SDHD patients are treated in-centre, the other operational costs for haemodialysis sessions can be considered similar to CHD.

In our country, the government is the sole financier of services for renal replacement therapy [33]. The reimbursement is around $800 US dollars for a patient-month in CHD. This amount should cover the materials used in the haemodialysis sessions, the operational costs (nurses, technicians, ancillary health professionals and administrative staff) and the physician fees, but exclude costs for medications that are prescribed for use out of dialysis session. Consequently, we believe that in our country, although the reimbursement is provided at present, the government also needs to increase the expense by between 40 and 50% to cover the costs of SDHD.

Finally, our results show that haemodialysis six times a week, 1.5 h per session, is safe for long-term treatment of patients with ESRD. Furthermore, we observed that in our patients, monitored for a long-time at a single dialysis centre in a developing country of the southern hemisphere, the SDHD presents a low rate of morbidity and mortality. Therefore, we believe that SDHD is an efficient renal replacement therapy for the treatment of patients with ESRD. However, further studies are necessary to show if this dialysis regimen could reduce the economic costs associated with the treatment, especially when dialysis membranes are reused, just as in this study.

Conflict of interest statement. None declared.



   References
Top
 Abstract
 Introduction
 Subjects and methods
 Results
 Discussion
 References
 

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Received for publication: 5.12.05
Accepted in revised form: 15. 3.06


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