NDT Advance Access originally published online on September 16, 2005
Nephrology Dialysis Transplantation 2006 21(1):166-175; doi:10.1093/ndt/gfi116
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© The Author [2005]. 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
A crossover study of short daily haemodialysis
1 University of Utah School of Medicine, Salt Lake City, UT, USA, 2 Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, UT, USA and 3 Emory University School of Medicine, Atlanta, GA, USA
Correspondence and offprint requests to: Alexander S. Goldfarb-Rumyantzev, Division of Nephrology and Hypertension, University of Utah Health Sciences Center, 85 North Medical Drive, East Rm 201, Salt Lake City, UT 84112, USA. Email: alex.goldfarb{at}hsc.utah.edu
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Abstract |
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Background. The benefits of daily haemodialysis (DHD) compared to conventional three times per week haemodialysis (CHD) have been described in a number of observational studies. Most of these previous studies however have not been performed with rigorous controls.
Methods. We performed a crossover study following an A-B-A design: phase A was 4 weeks of thrice weekly dialysis, 3–4 h per treatment (CHD); phase B was 8 weeks of six times/week dialysis, each session being one-half of the usual time (DHD) and phase A with 4 weeks of thrice weekly dialysis (CHD) was repeated. Patients characteristics: n = 12, six males; age 52±18 years, six diabetics.
Results. Weekly single-pool Kt/V, equilibrated Kt/V and standard Kt/V of urea, and ß-2-microglobulin clearance values were greater during DHD. Eight of 12 patients who completed the study reported symptomatic benefits from DHD that partially or completely disappeared during the second period of CHD. Quality of life of patients improved during DHD. Three patients had problems with arteriovenous access during DHD. Average blood pressure was lower during DHD (systolic 139.5±22.7 mmHg) compared to the initial (147.7±21.4 mmHg, P<0.001) and last (146.4±20.0 mmHg, P<0.005) CHD periods. No significant changes in predialysis haemoglobin and the serum concentration of albumin, phosphate, ß-2-microglobulin or B-type natriuretic peptides (BNP) were observed, although BNP trended downward during DHD and returned to baseline level during the second period of CHD. The dose of erythropoietin did not change significantly. Patient compliance with the dialysis schedule was lower during DHD. Dialysis staff perceived an increased workload but felt that the patients benefited medically from DHD.
Conclusions. The results of this cross-over study suggest symptomatic benefits and decrease in blood pressure, but there are potential problems with compliance and vascular access during DHD.
Keywords: blood pressure; daily haemodialysis; outcome; quality of life; quotidian haemodialysis; urea kinetics
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Introduction |
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The three-times-per-week schedule for chronic haemodialysis was established in the 1960s when once-per-week and twice-per-week regimens were found to be inadequate in preventing uraemic symptoms in chronic dialysis patients.
In recent years, a number of reports have described experiences with daily haemodialysis (DHD) in ESRD, each showing a beneficial effect in a relatively small patient population. A meta-analysis of 72 ESRD patients from nine centres [1] performing DHD showed lower blood pressure and increased haematocrit. Other studies have shown that the blood pressure, number and dose of antihypertensive medications, morbidity, and number of hospitalization decreased during DHD, as did global financial cost of medical treatment [2]. Other reports showed increased haematocrit with lower erythropoietin (EPo) usage [3], improved cardiac morphology and function [4], nutrition [5] and overall quality of life [6]. Most of this information was, however, derived from observational studies; only few controlled trials are available to date and are described below. A randomized trial suggested that daily haemodialysis was associated with better outcome in patients with acute renal failure, compared to those dialyzed three times per week [7].
Koshikawa et al. [8] performed a cross-over study of 23 patients following an A-B-A design and observed a decrease in blood pressure and better anaemia control. In a study by Williams et al. [9] authors used patients as self-controls and demonstrated the improvement in blood pressure, symptoms, nutrition, and quality of life after 4 weeks of daily dialysis in 21 patients.
The London, Ontario Study compared 11 patients undergoing DHD with 22 controls on conventional dialysis schedule. The results showed that DHD was associated with increased normalized protein catabolic rate, serum albumin levels, higher haemoglobin with less erythropoietin usage [3], improved quality of life, lower blood pressure, intradialytic weight gain, and extracellular fluid volume by multifrequency bioimpedance spectroscopy [10,11]. None of these papers report the clearance of middle molecules, and some of them did not report the clearance of small solutes.
We report herein the results of a controlled cross-over study designed to evaluate the short-term effects of DHD on patient symptoms, blood pressure and volume indicators, clearance of small and middle molecules, anaemia and other clinical parameters.
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Subjects and methods |
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Study design
This study was performed for a total of 16 weeks in each patient and followed an A-B-A design, where each patient served as his/her own control. During the first 4 weeks of the study (Phase A), each patient remained on his/her regular haemodialysis schedule (three-times-a-week, 3–4 h per treatment), while baseline data (see below) were collected. During weeks 5–12 (Phase B), each patient was dialyzed six times per week. The duration of each session in the new schedule was 50% of that in the regular schedule, such that the total amount of time on dialysis per week remained unchanged. The same data were collected in the 8 week intervention period as during baseline. During weeks 13–16 (Phase C), the patient returned to his/her regular schedule (three-times-a-week, 3–4 h per treatment) while data collection was repeated.
Patient population, inclusion and exclusion criteria
Prevalent haemodialysis patients on a three-times-per-week schedule from the University of Utah Dialysis program were recruited into the study after obtaining informed consent. Patients who had significant hypertension, intradialytic hypotension and muscle cramps, anaemia treated with high doses of EPO, large interdialytic fluid gain, hyperkalaemia or hyperphosphataemia were the primary recruitment targets, since they would presumably be more likely to benefit from the more frequent dialysis treatments. Patients were excluded if they were medically unstable, prisoners, pregnant women, minors below 18 years of age or mentally disabled.
Study procedures
The study protocol was approved by the University of Utah Institution Review Board. During the DHD period the patients were treated by haemodialysis six times per week, with the duration of each session reduced by 50%. Other dialysis conditions, such as blood pump speed, dialysate flow rate, dialysate composition, dialysis needles (15 gauge) remained unchanged. Cellulose acetate high-flux dialyzers CT190 (Baxter Healthcare Co., McGaw Park, IL) were used in this study. Processing of the dialyzers for reuse was performed according to routine clinical protocol using Renalin® (Minntech Corporation, Minneapolis, MN). The dry weight of each patient, antihypertensive medications, calcium and phosphate metabolism management were adjusted by the primary nephrologist and dialysis staff per routine clinical practice with no interference from the research team.
Routine laboratory tests (basic metabolic panel, calcium, phosphate, albumin and complete blood count) were performed by the University of Utah clinical laboratory (ARUP Laboratories, Salt Lake City, UT) using an automated analyzer. ß-2-microglobulin and B-type natriuretic peptide were measured by ELISA using commercial assay kits from Alpco (Windham, NH) and R&D (Minneapolis, MN), respectively.
Data collection and outcome measures
Collected data was divided into five categories. Patient compliance was assessed by the number of missed dialysis sessions and number of missed minutes of dialysis, as a result of either patient or staff non-compliance as well as withdrawals from the study. These data were collected throughout the study. Dialysis kinetic parameters, single pool (spKt/V), equilibrated (eKt/V) and standard (stdKt/V) urea Kt/V and ß-2-microglobulin clearance were monitored at baseline and once every 4 weeks. Blood samples for urea and ß-2-microglobulin kinetics were collected pre-dialysis, post-dialysis and prior to the following dialysis session. Post-dialysis samples were collected from the dialyzer arterial tubing after the blood pump was slowed down to 80 ml/min for 2 min.
Clinical parameters and patient well-being were monitored at baseline and every 2 weeks. The following clinical parameters were collected: blood pressure (pre-dialysis and post-dialysis systolic and diastolic blood pressure, number of blood pressure medications and their dosages), volume status (degree of pre-dialysis oedema as assessed by clinical examination by the dialysis staff, interdialytic fluid weight gain), symptoms of intradialytic hypotension (muscle cramps, headache, dizziness during or after dialysis), number of hospitalizations and emergency room visits. Patients were interviewed on a regular basis (at least once a week) by dialysis staff and investigators. The interview was not structured and was focused on patients' subjective feelings in an open-ended manner. In addition, before each dialysis procedure throughout the study, the patients were asked to complete a simple questionnaire about their well-being during and after the preceding dialysis treatment. Overall quality of life using the Kidney Disease and Quality of Life (KDQOL-SFTM 1.3) instrument [12] was evaluated four times during the study: at the end of 4, 8, 12 and 16 weeks. Values collected during daily dialysis phase were averaged to be compared with those collected during the three-times-a-week dialysis schedule. Mean scores on health status and quality of life scales have been transformed linearly into 0–100 point scales, with higher values representing better patient-assessed health status and quality of life.
Biochemical and haematological parameters consisting of serum electrolytes, albumin level, haemoglobin and dosage of erythropoietin were monitored twice at baseline and then every 2 weeks. The blood samples were collected before dialysis from the dialysis tubing and immediately centrifuged. The serum was separated, divided in aliquots and stored at –20°C until assay. Vascular access function was monitored every 4 weeks. The following parameters were collected: average blood flow through the dialyzer and concomitant dialyzer venous pressure, heparin dosage and incidence of vascular access failure that required interventions.
Data analysis
Dialysis dose during regular and DHD regimens was calculated as spKt/V [13], eKt/V, stdKt/V [14] and ß-2-microglobulin clearance (ml/min) [15]. Clinical and laboratory parameters were compared longitudinally and presented as individual trends. In addition, distribution statistics, such as means and standard error or frequencies, were computed for some of the outcomes. The results between three study periods were compared using t-tests or 
-square tests, depending on the distribution of the outcome.
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Results |
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Thirteen haemodialysis patients from three dialysis units were recruited into the study. One patient dropped out of the study after Phase A (the initial 4 weeks of regular dialysis), as he decided not to have more frequent needle puncture. His data were not included in the following analysis. One patient completed only 4 weeks of DHD (Phase B) instead of 8 weeks due to pain and swelling of her arteriovenous (AV) fistula, which occurred during that period; her data were included in the analysis. Overall, the data obtained from 12 patients were analysed (Figure 1).
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Baseline patient characteristics are presented in Table 1. The average (±mean) age of the study group was 52±18 years, with 50% being male and six patients being diabetic, 50% white, 30% Hispanic, 20% Asian. The average ESRD duration was 26±21 months. The average dialysis treatment time during the thrice-weekly schedule was 231±16 min per session. The dialysis composition did not change during the study with average sodium 139±3.6 mg/dl, potassium 2.25±0.75 mg/dl, calcium 3.4±0.4 mg/dl and bicarbonate 34.6±3.3 mg/dl.
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Patient compliance
During the initial period of 4 weeks of regular dialysis (Period A), a total of two dialysis sessions were missed in all 12 patients (Table 2). An additional 697 minutes were missed due to dialysis sessions being shortened or late start. A total of 14 dialysis sessions were missed during the 8 week period of DHD (Period B) in addition to 271 min of missed time. During the final period of regular dialysis (Period C), no dialysis sessions were missed, while the total missed time was 125 min.
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Reasons for missed time during DHD were similar to those for regular dialysis and included late arrival, need for interruption (e.g. severe diarrhoea, incontinence), and premature termination because of cramps, dizziness and pain or bleeding from the vascular access. Missed time was never attributed to staff non-compliance.
Urea Kt/V and clearance of ß-2-microglobulin
Weekly spKt/V (P<0.05), eKt/V (P = 0.054) and stdKt/V (P<0.001) increased by 61%, 45%, and 61%, respectively, during DHD, compared to Period A. The dialyzer clearance of ß-2-microglobulin tended to increase, although this did not reach statistical significance (P = 0.369) (Table 3). After the patients returned to their regular schedule (Period C), the values of weekly spKt/V (P = 0.108), eKt/V (P = 0.218), stdKt/V (P<0.001) and ß-2-microglobulin clearance (P = 0.691) decreased compared to Period B towards baseline levels.
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Blood pressure control and volume status
The number of antihypertensive medications remained unchanged throughout the study in all patients. The mean blood pressure values in individual patients are presented in Figure 2 and Table 4. Blood pressure decreased during DHD, compared to Phase A. Pre-dialysis systolic blood pressure decreased from 147.7±21.4 to 139.5±22.7 mmHg (P<0.001). Predialysis diastolic blood pressure decreased from 83.9±14.8 to 77.9±1 6.3 mmHg (P<0.001). Mean blood pressure returned to the baseline values after patients resumed the regular dialysis schedule (Table 4). There also seemed to be a carry-over effect in some patients after they were switched back to regular dialysis schedule, in that the blood pressure remained lower in Period C compared to Period A. Pre-dialysis and post-dialysis actual weight, estimated dry body weight, and goal weight did not change significantly during the study. The oedema in two patients out of seven, who had oedema at the beginning of the study improved during DHD (with no change in body weight in either of them).
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Subjective status and quality of life
Eight of 12 patients stated that they felt better subjectively on DHD (Table 5, Figure 3). The trends demonstrate the decrease in symptoms after the change in dialysis schedule from regular dialysis (Period A) to DHD (Period B) with a tendency to recur after returning to the regular schedule (Period C).
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The quality of life analysis demonstrated significant improvement in symptoms, burden of kidney disease, social interaction and functioning, and energy level on DHD. After patients returned to regular three-times-per-week dialysis (Period C), they scored significantly lower on effects of kidney disease, social interaction and functioning, and physical functioning compared to their scores on DHD (Table 6).
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Biochemical and haematological parameters
None of the changes in laboratory parameters (serum phosphorus, calciumxphosphate product, albumin, or ß-2-microglobulin) reach statistical significance except the value for haemoglobin between the daily dialysis period (Period B) and final regular period (Period C) (P<0.001) (Table 7). Although not statistically significant, the dose of EPO (per one injection, administered three times a week) and B-type natriuretic peptide (BNP) level trended down during DHD and increased when regular dialysis schedule was resumed.
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Vascular access function
All patients except for one [patient #11, native arterio-venous fistula (AVF) failed before the study start, had a tunnelled catheter throughout the study] used AVFs throughout the study. Three patients had problems with vascular access during DHD, that included haematoma in one patient, pain and moderate swelling around the needle puncture sites after 1 month of DHD in one patient (advised by primary nephrologist to discontinue DHD), AVF occlusion with unsuccessful revision and tunnelled catheter placement in one patient. Venous pressure minus negative arterial pressure (mmHg) divided by blood flow rate (ml/min) showed no obvious trends between the different phases of the study.
Staff feedback
Immediately after study completion, a brief questionnaire was distributed to 17 dialysis technicians and nurses who were directly involved in the care of the patients in the study; all of them completed the questionnaire. All of them stated that the DHD schedule increased their workload substantially. On a scale of –10 to 10, average workload increase was 6.2±2.6, four respondents graded the change in work load as 10 or 10+, seven respondents graded it as 6 or 8, and six respondents graded it between 2 and 5. To the questions ‘did patients say they feel better or worse’ and ‘do you think they felt better or worse’ (on DHD), all respondents said ‘better’ except for one missing entry. On a scale of –10 to +10 (positive values reflecting improvement, negative values reflecting worsening), the change in patient general well being was graded as 3.5±2.2, change in patients’ mood as 3.2±3.1, improvement in patient uraemic symptoms as 3.4±2.8, and patients’ tolerance of DHD was graded 4.9±2.9, as reported by the staff. Additionally, in a separate question, staff members were offered to add their comments in an unstructured format. Most common comments were related to increase in workload and patients vascular access tolerance of DHD.
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Discussion |
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TopAbstractIntroductionSubjects and methodsResultsDiscussionReferences |
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Beneficial effects of DHD have been described extensively in recent literature [6,10,11]. Most of the studies, however, were performed in a non-controlled fashion. The crossover study (A-B-A design) presented here used patients as their own controls; in addition, it helps to circumvent the problem with seasonal variations of study parameters in uncontrolled longitudinal studies.
We have not formally evaluated the reason for patient willingness and unwillingness to be enrolled in this particular study, but the most common reason to agree to participate seemed to be the hope that they would feel better and require less medication. The most common reason why patients refused to be enrolled was more frequent needle punctures, interference of DHD schedule with other activities and transportation concerns. Patient compliance may be a problem with DHD, as reflected by the increased number of missing dialysis sessions (both in absolute numbers and in percent of total number of dialysis sessions per week) in the present and previous studies [16].
DHD regimens are more effective than conventional HD in improving weekly urea clearance, as measured by spKt/V, stdKt/V and eKt/V. Similar to other studies [17], we observed considerable increase in urea clearance measured by spKt/V, eKt/V and stdKt/V.
One of the postulated consequences of DHD is a beneficial effect on hypervolaemia. Out of seven patients with peripheral oedema at the beginning of the study, it improved in two. Lowering of the blood pressure, however, is one of the significant findings of this study. Both pre- and post-HD systolic and diastolic blood pressure decreased during the daily regimen and returned to baseline values when patients resumed the regular dialysis schedule. In The London Daily/Nocturnal Haemodialysis Study of daily dialysis [10], a significant decrease in mean arterial pressure was observed at 6 months of DHD associated with a decrease in antihypertensive drugs (baseline mean arterial pressure (MAP) 106.5±13.7; MAP after 18 months of daily dialysis therapy 100.9±6.9 mmHg). The magnitude of changes in predialysis blood pressure is consistent with that observed in our study, where mean arterial pressure changed from 105 mmHg during thrice weekly dialysis (Phase A) to 98 mmHg during DHD (Phase B). A concomitant decrease in extracellular fluid volume, as determined by bioimpedance analysis, was observed in DHD patients compared to controls [10]. Lowering of the blood pressure was also demonstrated in a daily dialysis study of 23 patients with a cross-over design similar to the present project [8]. In this study we did not use more objective tests of the volume status (e.g. bioimpedance analysis) or made systematic attempt to decrease the patients’ dry weight. Therefore, despite the observed effect of DHD on BP, the more significant effect on BP control or extracellular volume status may have been missed.
Subjective status of most of the patients in our study and their general well-being improved with DHD. Patients stated that they felt better in between dialyses with relief of some of the uraemic symptoms with decreased incidence of intradialytic symptomatic hypotension. We also demonstrated improvement in patients’ quality of life measured by the standard KDQOL-SFTM 1.3 instrument. Other studies have also demonstrated improved patient subjective well-being and quality of life [6].
We did not find any convincing trends in anaemia control. The results of prior studies are conflicting. Anaemia control improved in some studies [8], but other reports did not show significant change [18]. The lack of significance in haemoglobin change might be explained by the small sample size. Also, while interpreting the data one might hypothesize that blood loss could potentially increase with the increased number of dialysis sessions during daily dialysis period.
We also did not observe any changes in serum albumin that were reported by others during an 18 month follow-up [16,19]. The small sample size and shorter follow-up duration in our study might have been may be the reason for this discrepancy.
Furthermore, we did not observe any significant changes in serum calcium and phosphorus. In a small observational study, DHD seemed to be associated with lower mean values for both phosphorus and calcium x phosphate product [16]. Neither of these parameters changed significantly in patients on DHD in The London Daily/Nocturnal Haemodialysis Study [20].
We observed several vascular access problems during DHD phase. In the London Daily/Nocturnal Haemodialysis Study even though there was no difference in the access flow rates, patients with AV fistulae on daily dialysis had twice as many access complications as the control group and almost three times more interventions [11]. Employment of the button-hole technique of cannulation or single needle may ameliorate this potential problem. Small sample size and lack of standardized monitoring of the vascular access do not allow us to make strong statements about the role of daily dialysis.
In comparison to other reports in the literature, our study has a short follow-up period, which combined with the small sample size might not clearly demonstrate the significant effect of daily dialysis on certain clinical outcomes. In particular, anaemia control, improvement in calcium and phosphate metabolism, and nutritional status might take longer to show any response. The same argument may apply to the quality of life assessment, which had a positive trend, and might have had greater effect and significance in a study with a longer follow-up. Since the study was performed using dialyzers reused according to the routine clinical protocol at the Dialysis Program of The University of Utah, theoretically, the results of the protocol without the reuse might be somewhat different.
In conclusion, we found that predialysis blood pressure significantly decreased with eight weeks of DHD, while several other clinical and laboratory parameters show trends of change. There appeared to be an increase in patient non-compliance, perception of increased work load by the staff and more vascular access problems associated with this modality. Although the present study is one of very few controlled studies performed on DHD, the small number of patients studied prohibit definitive conclusions.
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Acknowledgments |
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This study was funded by the Dialysis Research Foundation, Ogden, UT. The cooperation of the participating patients, dialysis staff and referring nephrologists is greatly appreciated.
Conflict of interest statement. None declared.
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References |
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- Woods JD, Port FK, Orzol S et al. Clinical and biochemical correlates of starting ‘daily’ hemodialysis. Kidney Int 1999; 55: 2467–2476[CrossRef][Web of Science][Medline]
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Accepted in revised form: 11. 8.05
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