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Vol. 119, No. 2, 2011
Issue release date: September 2011
Nephron Clin Pract 2011;119:c138–c144
(DOI:10.1159/000324428)

Haemodiafiltration Does Not Reduce the Frequency of Intradialytic Hypotensive Episodes when Compared to Cooled High-Flux Haemodialysis

Pinney J.H.a · Oates T.a · Davenport A.b
aCenter for Nephrology, Royal Free Hospital, and bCenter for Nephrology, University College London, Medical School, Royal Free Campus, London, UK
email Corresponding Author

Abstract

Introduction: Intradialytic hypotension remains the commonest complication of outpatient haemodialysis (HD) treatments. On-line haemodiafiltration (HDF) has been reported to reduce the frequency of intradialytic hypotension. We introduced on-line HDF into our satellite dialysis program, and prospectively audited the effect of HDF on cardiovascular stability. Methods: 34 patients’ dialysis schedules (Tuesday/Thursday/Saturday) were converted to online post-dilutional HDF, and 44 patients’ dialysis schedules (Monday/Wednesday/Friday) remained on high-flux HD. Blood pressure and intra-treatment complications were monitored prospectively for 12 months. Results: There was no significant change in pre-treatment mean arterial blood pressure in the HDF group during the 12 months of the study (pre-treatment 113.7 ± 0.7 mm Hg vs. 109.3 ± 2.8 after 12 months), or for the HD cohort (113.9 ± 2.7 vs. 117.9 ± 2.6). However, the frequency of intradialytic hypotensive episodes was greater for the HDF cohort: 25.9 versus 16.5% in the HD cohort, p = 0.0116. During HDF, on average >16 litres of substitution fluid was used and the median temperature was 36°C (35°C–36°C), higher than the dialysate in the HD cohort which was 35°C (35°C–36°C), p < 0.05. Conclusion: In this study, HDF did not improve blood pressure control or reduce the frequency of intradialytic hypotensive episodes compared to high-flux HD using cooled dialysate.


 Outline


 goto top of outline Key Words

  • Haemodiafiltration
  • Blood pressure
  • Intradialytic hypotension

 goto top of outline Abstract

Introduction: Intradialytic hypotension remains the commonest complication of outpatient haemodialysis (HD) treatments. On-line haemodiafiltration (HDF) has been reported to reduce the frequency of intradialytic hypotension. We introduced on-line HDF into our satellite dialysis program, and prospectively audited the effect of HDF on cardiovascular stability. Methods: 34 patients’ dialysis schedules (Tuesday/Thursday/Saturday) were converted to online post-dilutional HDF, and 44 patients’ dialysis schedules (Monday/Wednesday/Friday) remained on high-flux HD. Blood pressure and intra-treatment complications were monitored prospectively for 12 months. Results: There was no significant change in pre-treatment mean arterial blood pressure in the HDF group during the 12 months of the study (pre-treatment 113.7 ± 0.7 mm Hg vs. 109.3 ± 2.8 after 12 months), or for the HD cohort (113.9 ± 2.7 vs. 117.9 ± 2.6). However, the frequency of intradialytic hypotensive episodes was greater for the HDF cohort: 25.9 versus 16.5% in the HD cohort, p = 0.0116. During HDF, on average >16 litres of substitution fluid was used and the median temperature was 36°C (35°C–36°C), higher than the dialysate in the HD cohort which was 35°C (35°C–36°C), p < 0.05. Conclusion: In this study, HDF did not improve blood pressure control or reduce the frequency of intradialytic hypotensive episodes compared to high-flux HD using cooled dialysate.

Copyright © 2011 S. Karger AG, Basel


goto top of outline Introduction

Haemodialysis (HD) is predominantly a diffusive process designed to clear small solutes. Studies have shown that above a critical threshold [1], additional HD treatment to increase urea clearance does not appear to improve dialysis patient survival [2]. This led to the hypothesis that larger solutes may be important in determining medium- to longer-term dialysis patient survival [3]. To increase the spectrum of solutes cleared during HD, dialysers with greater pore size have been developed, and over the past 30 years, the proportion of patients dialysing with high-flux membranes has increased compared to low-flux dialysers [4]. Although the clearance of middle-sized solutes can be increased further by dialyser membranes designed to increase internal filtration [5], many centres have turned to convective based techniques, including haemofiltration or haemodiafiltration (HDF) [6].

In addition to increasing middle molecule clearances, convective treatments have also been reported to improve cardiovascular stability during treatment sessions [7] and reduce the frequency of intradialytic hypotension [8] both with haemofiltration and HDF [8,9]. Other centres have also reported an improvement in interdialytic blood pressure control following the introduction of HDF [10]. However, other studies have failed to confirm these findings [11], and it has been suggested that any benefit reported may have been due to additional thermal cooling associated with HDF [12].

To compare the effects of HDF with high-flux HD on intradialytic hypotension and blood pressure control, we prospectively collected data following the introduction of HDF into our clinical practice.

 

goto top of outline Methods and Patients

We introduced HDF into one of our satellite dialysis centres once repeated water testing had confirmed ultrapure dialysate [13]. As we rely on part-time staff, to help aid the introduction of HDF – a new technique – in terms of patient safety, staff training, testing and maintaining dialysis machines, we elected to convert all patients dialysing on the Tuesday/Thursday/Saturday morning and afternoon dialysis shifts to post-dilution HDF, whereas patients dialysing on the Monday/Wednesday/Friday morning, afternoon and evening shifts continued with high-flux HD. We have no selection policy as to the allocation of dialysis schedules at our satellite centres.

All patients were dialysed with Fresenius 4008 machines and polysulphone dialysers (Fresenius, Bad Homberg, Germany), with a dialysate flow of 800 ml/min, and administered low-molecular-weight heparin (Tinzaparin, Leo Laboratories, Denmark) as a venous bolus [14]. The HDF component of treatment ranged from 60–85 ml/min, with an average of >16 litres exchanged per treatment session (table 1). Dialysis machines were regularly serviced and calibrated. Ultrafiltration profiles were designed to be constant during treatments, unless patients became symptomatically hypotensive [15]. Patients were followed for 12 months, and then all patients were treated by post-dilution HDF.

TAB01
Table 1. Dialysate and substitution fluid composition and duration of therapy

As weight gain [16] and the risk of intradialytic hypotension varies during the course of the dialysis weekly schedule [17], we averaged intradialytic weight gains and pre- and post-treatment blood pressures during the week (3 sessions) when dialysis adequacy was checked. Symptomatic hypotension was defined as a nursing intervention in response to hypotension, including stopping ultrafiltration and administration of intravenous fluids.

Ethical approval was granted by the local ethical committee as audit and clinical service development.

goto top of outline Statistical Analysis

Results are expressed as means ± standard error of the mean, medians and interquartile range, or as a percentage. Statistical analysis was by ANOVA with Tukey’s multiple comparison test correction where appropriate, as well as Students’ t and paired t test. For nonparametric data, a Mann-Whitney U test or the Wilcoxon rank-sum pair test; χ2 test with Yate’s correction was used for small numbers (Graph Pad Prism version 3.0; Graph Pad, San Diego, Calif., USA). A recent multicentre trial reported a reduction in intradialytic hypotension with HDF compared to HD with an odds ratio of 0.45 [18]. With symptomatic intradialytic hypotension of 15% reported by the PanThames Group [17], we calculated that we had to study around 550 sessions. Statistical significance was taken at or below the 5% level.

 

goto top of outline Results

Patient groups were relatively well matched in terms of age, gender, ethnicity, dialysis vintage, prevalence of diabetes, previous cardiac history and current left ventricular function (table 2). Although more patients had a history of diabetes in the HDF group, this was not significantly different, and only 2 patients (4.8%) required insulin, 7 (16.7%) oral hypoglycaemics and 3 (7.1%) dietary control. Diabetic control did not change during follow-up; mean HbA1c was 6.89 ± 0.4 (normal < 6%) prior to HDF, 6.49 ± 0.4 at 3 months, 6.49 ± 0.4 at 6 months and 6.30 ± 0.5 at 12 months. Transthoracic echocardiograms showed similar cardiac ejection fractions for both groups. Urine output did not differ between groups, although slightly more patients passed >300 ml urine per day in the HD group and were prescribed diuretics (table 2), although this was not significantly different between the groups (χ2 = 2.59, p = 0.107). Similarly, more patients were prescribed antihypertensive agents in the HD group, but this was not significant, and both groups had a similar percentage of patients prescribed midodrine at pre-treatment to help avoid intra-treatment hypotension.

TAB02
Table 2. Patient demographics (HD vintage)

We prospectively compared the HDF and HD cohorts during the 12-month follow-up, and also included the 3 months prior to switching from high-flux HD to HDF to allow for intra-patient comparisons within the HDF cohort. During this prospective observational study, no patient dropped out from the high-flux HD cohort; however, 4 patients dropped out of the HDF cohort (1 patient transplanted after 3 months, and 3 died after 8, 9 and 11 months, respectively).

Dialysis adequacy as assessed by single-pool Kt/V obtained with the mid-week session was averaged for each 3-month period and was not different between the groups: HD 1.52 ± 0.05 versus HDF 1.55 ± 0.03 (0–3 months), 1.56 ± 0.04 versus 1.52 ± 0.02 (3–6 months), 1.56 ± 0.04 versus 1.56 ± 0.02 (6–9 months) and 1.59 ± 0.04 versus 1.57 ± 0.03 (9–12 months). During the study period, there were no reported clotted circuits in either group. The median dose of tinzaparin pre-HD in the HDF cohort was 2,500 IU (2,500–3,500), did not change with HDF [median 2,500 IU (2,500–3,500)] and was not different from the HD cohort [2,500 IU (2,500–3,500)].

Average pre-dialysis systolic and diastolic blood pressures did not change significantly over the 12 months of the study (fig. 1) and were not initially different between the cohorts, although pre-treatment systolic blood pressure was higher in the HD cohort. Average pre-treatment diastolic blood pressures did not significantly change over time and did not differ between the cohorts. Average post-treatment systolic and diastolic blood pressures did not change over time in either cohort, and were not different between the cohorts for the first 10 months of the study; thereafter post-treatment systolic blood pressure was greater in the HD cohort (fig. 2). During the study period, antihypertensive medications were increased in 6.8% of the HD group and 17.6% of the HDF cohort, and reduced in 27.3% of the HD cohort and 6.1% of the HDF cohort.

FIG01
Fig. 1. Average pre-treatment systolic and diastolic blood pressure in the HDF cohort, starting 3 months prior to conversion to HDF, and then for 12 months following conversion to HDF, and for 12 months in the HD cohort. Values expressed as means. + p < 0.05 vs. HD.

FIG02
Fig. 2. Average post-treatment systolic and diastolic blood pressure in the HDF cohort, starting 3 months prior to conversion to HDF, and then for 12 months following conversion to HDF, and for 12 months in the HD cohort. Values expressed as means. * p < 0.05 vs. HD. MAP = Mean arterial blood pressure.

During HDF, the difference between pre-session and post-session serum sodium [start: 1 mmol/l (–1.5 to 2.0); 3 months: 0 (–1.5 to 3); 6 months: 0.5 (–2 to 2); 9 months: 2 (0.5–2); and 12 months: 0 (–2.5 to 3)] was not statistically different to that for HD [start: –1 mmol/l (–2.5 to 1.5); 3 months: –1.5 (–2.5 to 1.5); 6 months: 0 (–3.5 to 1); 9 months: 0 (–3.5 to 2); and 12 months: –1 (–2.5 to 1)]. The median dialysate calcium concentration was higher than that for HD, but not statistically significant (table 1).

As intradialytic hypotension is more common with the first dialysis session of the week, we analysed blood pressure changes over the dialysis week for each month from more than 1,500 HD and 1,100 HDF sessions. The average percentage fall in mean arterial blood pressure was similar for both cohorts during the study, apart from month 9, and did not significantly change over time (fig. 3). However, when analysed together, the fall in mean arterial pressure was greater with HDF (fig. 4). Prior to converting to HDF, symptomatic hypotensive episodes [19] occurred in 19.6% of HD treatments in the HDF cohort, and then 25.9% during HDF, which was significantly greater than 16.5% which occurred in the HD cohort (p = 0.016). Our standard unit policy was to use cooled dialysate (35°C); however, on switching the Tuesday/Thursday/Saturday cohort to HDF, many patients complained of feeling increasingly cold during treatment and dialysate temperature was therefore increased to alleviate patient symptoms, and as such there was a temperature difference between the cohorts (table 2).

FIG03
Fig. 3. Average percentage fall in mean arterial blood pressure post-treatment in the HDF cohort, starting 3 months prior to conversion to HDF, and then for 12 months following conversion to HDF, and for 12 months in the HD cohort. Values expressed as means ± SEM. * p < 0.05 vs. HD. MAP = Mean arterial blood pressure.

FIG04
Fig. 4. Percent fall in mean arterial blood pressure post-treatment in the HDF and HD cohorts. Values expressed as medians and interquartile range. * p = 0.032 vs. HD.

Although the HDF cohort were marginally heavier, this was not statistically different (table 3), and weight did not change over the time course of the study in either group. The average percentage ultrafiltration volume did not differ between the cohorts and did not change statistically over time. Similarly, serum albumin, measured by the bromocresol green method, did not change significantly in either group (HDF cohort: 37.9 ± 0.9 vs. 38.3 ± 0.8 g/dl; HD group: 39 ± 0.6 vs. 38.4 ± 0.8 g/dl).

TAB03
Table 3. Weight pre- and post-HD (kg) for the HD and HDF groups, and % change in weight following treatment session (%Δ), starting 3 months prior to switch to HDF

 

goto top of outline Discussion

HDF increases convective solute losses compared to standard HD [20], with reports of increased phosphate [21] and β-2-microglobulin clearances [22]. In addition, HDF has been reported to improve cardiovascular stability during treatment sessions, with less intra-treatment hypotension [7,8,22,23], as well as improve blood pressure control [10].

In our prospective observational study, cohorts did not differ in terms of age, gender, ethnicity, dialysis vintage, prevalence of diabetes, cardiovascular disease or left ventricular function as assessed by transthoracic echocardiography and residual renal function. We found no improvement in overall blood pressure control. Slightly more HD patients were prescribed antihypertensives at the start of the study, and during the course of the study, more HD patients had a reduction in antihypertensive medications. Previous reports have suggested that sodium removal may differ between convective and diffusive methods, and that post-dilution haemofiltration can lead to a greater positive sodium balance than standard HD when using the same sodium concentration in dialysates and substitution fluids [24]. However, other balance studies measuring sodium losses with pre-dilutional haemofiltration have not shown any significant difference in sodium removal compared to HD [25]. In our study, we did not measure sodium balance, and the difference between the pre- and post-serum sodium concentrations was not different between the groups, although the median was more likely to be zero or negative in the HD group and zero or positive in the HDF group, suggesting that there may have been a difference in sodium balance.

Earlier studies observed improved cardiovascular stability with less intra-treatment hypotension during intermittent haemofiltration compared to HD [7]. Theories were developed as to whether this was due to the removal of cardiac depressant toxins, and ouabain-like substances [7,20]. Although several groups have also reported fewer intra-treatment hypotensive episodes during HDF [8,10,18,22,23], we were unable to confirm these findings. In our study, there was no consistent pattern in the fall in systolic or mean arterial blood pressure during a treatment session. However, overall the percentage fall in mean arterial pressure was greater with HDF compared to high-flux HD, despite no difference in ultrafiltration volumes or session treatment times. Previous studies have reported no difference in intra-treatment hypotension rather than a greater risk of hypotension with HDF [11]. Other studies have suggested that the cardiovascular stability associated with HDF is due to the cooling effect experienced with HDF [12]. In our study, we typically used cooled dialysates as standard practice to reduce the risk of intradialytic hypotension [16]. However, when patients initially converted from HD to HDF, many patients complained of feeling too cold during treatment, and therefore the temperature was increased, and as such the median temperature was 1°C higher in the HDF cohort. This difference in thermal cooling may explain some of the differences observed in intra-treatment cardiovascular stability and the fall in blood pressure following the treatment session [26]. As studies have reported that HDF reduces intra-treatment hypotension compared to low-flux HD when using dialysates at standard body temperature [18] and that HDF causes greater cooling than low-flux HD [27], intradialytic hypotension can be reduced by using cooled dialysate [27]. When HDF and HD were matched for cooling, no differences in cardiac function or hypotension were observed [28,29]. We were unable to asses thermal energy balance during treatment; however, as we used high-flux dialysers designed to increase internal filtration [4], there may have been a greater cooling effect with our high-flux HD group using cooled dialysate compared to previous studies using low-flux dialysis [27,28,29].

Although there was no significant difference in dialysate calcium concentrations, the median calcium concentration was higher in the HDF group. Compared to many centres, we typically use lower calcium dialysates [30], and lower dialysate calcium concentrations have been reported to result in greater intradialytic cardiovascular instability [31].

There have been reports of increased appetite following initiation of HDF [10], and others have recorded increased nutritional intake [21]. In our study, there was no change in post-treatment weight or serum albumin in either group over time. This is in keeping with other reports which did not observe any changes in nutritional status [11].

On the positive side, HDF was successfully introduced into our satellite unit. During the 12 months, there was no increased incidence of haemodialyser clotting, which can occur due to increased intradialyser pressures [32], and no increase in low-molecular-weight heparin requirements. Similarly, ultrapure water quality was maintained during the course of the study [33]. However, we did not observe any improvement in cardiovascular stability in terms of reduction in the frequency of intra-treatment hypotension [34] and the fall in blood pressure during a HDF treatment session.

 

goto top of outline Acknowledgements

We would like to thank the nursing staff of the Barnet satellite dialysis unit.

 

goto top of outline Disclosure Statement

The Royal Free NHS Trust provided funding for this paper and Fresenius Medical Company provided the reinfusion line used during HDF treatment.


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 goto top of outline Author Contacts

Thomas Oates
Center for Nephrology, Royal Free Hospital
University College London, Medical School, Royal Free Campus
London NW3 2 QG (UK)
Tel. +44 207 830 2930, E-Mail oates_tom@hotmail.com


 goto top of outline Article Information

Received: November 5, 2010
Accepted: January 13, 2011
Published online: July 8, 2011
Number of Print Pages : 7
Number of Figures : 4, Number of Tables : 3, Number of References : 34


 goto top of outline Publication Details

Nephron Clinical Practice

Vol. 119, No. 2, Year 2011 (Cover Date: September 2011)

Journal Editor: El Nahas M. (Sheffield)
ISSN: 1660-2110 (Print), eISSN: 1660-2110 (Online)

For additional information: http://www.karger.com/NEC


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Abstract

Introduction: Intradialytic hypotension remains the commonest complication of outpatient haemodialysis (HD) treatments. On-line haemodiafiltration (HDF) has been reported to reduce the frequency of intradialytic hypotension. We introduced on-line HDF into our satellite dialysis program, and prospectively audited the effect of HDF on cardiovascular stability. Methods: 34 patients’ dialysis schedules (Tuesday/Thursday/Saturday) were converted to online post-dilutional HDF, and 44 patients’ dialysis schedules (Monday/Wednesday/Friday) remained on high-flux HD. Blood pressure and intra-treatment complications were monitored prospectively for 12 months. Results: There was no significant change in pre-treatment mean arterial blood pressure in the HDF group during the 12 months of the study (pre-treatment 113.7 ± 0.7 mm Hg vs. 109.3 ± 2.8 after 12 months), or for the HD cohort (113.9 ± 2.7 vs. 117.9 ± 2.6). However, the frequency of intradialytic hypotensive episodes was greater for the HDF cohort: 25.9 versus 16.5% in the HD cohort, p = 0.0116. During HDF, on average >16 litres of substitution fluid was used and the median temperature was 36°C (35°C–36°C), higher than the dialysate in the HD cohort which was 35°C (35°C–36°C), p < 0.05. Conclusion: In this study, HDF did not improve blood pressure control or reduce the frequency of intradialytic hypotensive episodes compared to high-flux HD using cooled dialysate.



 goto top of outline Author Contacts

Thomas Oates
Center for Nephrology, Royal Free Hospital
University College London, Medical School, Royal Free Campus
London NW3 2 QG (UK)
Tel. +44 207 830 2930, E-Mail oates_tom@hotmail.com


 goto top of outline Article Information

Received: November 5, 2010
Accepted: January 13, 2011
Published online: July 8, 2011
Number of Print Pages : 7
Number of Figures : 4, Number of Tables : 3, Number of References : 34


 goto top of outline Publication Details

Nephron Clinical Practice

Vol. 119, No. 2, Year 2011 (Cover Date: September 2011)

Journal Editor: El Nahas M. (Sheffield)
ISSN: 1660-2110 (Print), eISSN: 1660-2110 (Online)

For additional information: http://www.karger.com/NEC


Copyright / Drug Dosage

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

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