Jaarsveld slide di 21

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1 1 di 21 Nocturnal in-center haemodialysis: practical issues and clinical results Brigit van Jaarsveld, Amsterdam, Netherlands Chairs:James Tattersall, Leeds, UK Pieter ter Wee, Amsterdam, The Netherlands Dr. Brigit van Jaarsveld Department of Nephrology Free University Medical Center Amsterdam, the Netherlands slide 1 slide 2

2 2 di 21 Thank you. Ladies and gentlemen. The very interesting previous lectures showed us two sides of a spectrum. On the one hand, how to intensify haemodialysis within a conventional 3 times 4-hour schedule and on the other, how to reach all but maximum dialysis time by doing at home almost every night. Well, the present talk will address something in between: nocturnal does 8 hours haemodialysis performed in-centre 3-4 times a week. I will start with an overview with the evidence there is so far on 3 or 4 times a week and continue with practical problems one can encounter during the realisation of an in-centre nocturnal programme. slide 3 Well, the current evidence comes from the pioneers in nocturnal haemodialysis who deserve a lot of admiration; in my opinion, nocturnal dialysis is a big revolution. It started in France in 1968 where doctors Chazot, Jean, Laurent and Charra treated hundreds of patients in Tassin, near Lyon. In the 1990s Canada and the US followed, then Australia and after 2000, there are reports from Turkey, from China and many other countries in Europe followed. For the present talk, I collected the main publications from these centres and focused specifically on the evidence about 8-hours 3 times and not on daily long dialysis unless I stated so explicitly. slide 4

3 3 di 21 I would like to present the results in the light of one of my patients again just like the previous speaker, Mr P, who started dialysis some 30 years ago and was transplanted in He had to resume dialysis shortly thereafter and did hemo and peritoneal dialysis. He had a second transplant, which functioned much longer, and in the meantime some coronary obstruction. You know these patients but eventually, his transplant failed and he had to resume dialysis. Because of the peritonitis in the past PD was not an option. He had two transplants, so was highly immunised so now he faces sort of eternal haemodialysis. slide 5 The question is, what are we going to offer him? Well, he is a painter and he wants to devote as much time as possible to his art. He s single and he doesn t want to dialyse at home because his house is full of brushes and die stuff and so on. So I advised him to do in-centre nocturnal. slide 6

4 4 di 21 Surprise, but I m curious about your opinion, there s no right answer to these questions. Please raise your hands if you believe in A. mortality in nocturnal in-centre dialysis is decreased compared to conventional haemodialysis. Who believes in A? Thank you. Who says B., hospital admissions are less frequent than with conventional haemodialysis? Almost the same. Thank you. Who believes neither A or B and advises my patient to do the in-centre only because it provides him with more spare time? Who thinks C? That s a lot. Thank you. slide 7 Well, is there any evidence on the mortality? There are no RCTs comparing conventional with 3 or 4 times a week long but there are observational data. This is from France showing 20 years of patient survival in different age categories. In most of our centres, mortality is 15-30% per year, depending on the sort of patients that we have to treat. But look here at patients above 65 years of age. The lower line here. At 5 years, almost 50% is alive, so that is quite remarkable. slide 8

5 5 di 21 Comparing their figures with others by means of the standardised mortality ratio and that is the ratio of observed to expected deaths and Woolf published tables on that in 1994 from the US renal data system. These tables from Woolf enable other centres to compare their mortality data and it s important to realise that mortality within the first 90 days is included in these tables. Now you see that over the years the number of observed deaths is about half of the number of expected ones with a standardised mortality ratio of about 0.5. So that s quite low mortality in Tassin. slide 9 What are the data in the US and Canada? Well, here an impressive cohort of 77 dialysis centres including incident nocturnal dialysis patients, in-centre comparing them with a matched cohort of conventional patients of 2000 patients. The way of matching is of course, crucial for our appraisal of this study. Here it is done on the basis of the propensity score, which is not only an adjustment for the baseline variables but also takes into account that a certain treatment, here the nocturnal dialysis, can have a different outcome in groups with different baseline variables. slide 10

6 6 di 21 In this study, also early mortality was included and a survival curve of this cohort shows a mortality of 19% in 2 years, whereas this was 27% in the conventional group resulting in a 25% risk reduction. However, after adjustment for age, BMI and vintage, this was not significant anymore. slide 11 Well, finally another report on mortality, we saw that already mortality in nocturnal haemodialysis and here this is everything 3, 4, 5, 6 and 7 times a week nocturnal, a famous slide comparing this with the results of renal transplantation with a deceased or living donor. The dark grey line is the deceased donor and the black line is the nocturnal patients. slide 12

7 7 di 21 We see that mortality is comparable and it was matched and adjusted for race, diabetes and vintage. So far about mortality. Well, we had a second reason for starting in-centre nocturnal dialysis and it is, is his hospitalisation reduced? T slide 13 Well, this is again the US and Canada group. On the left side, it was the mortality, which was not significantly different from the conventional reference group, but the hospitalisation is different, reduced with a rate of nine and half hospital days per patient year versus thirteen and a half in the conventional group. Apart from hospitalisation, there were also other soft cardiovascular endpoints. The Turkish group showed an improvement in pulse wave velocity with nocturnal. slide 14

8 8 di 21 A Shanghai study demonstrated better endothelial function and for left ventricular mass there is a meta-analysis in AGKD with the effect of long intermittent haemodialysis in the lower half and a forest plot shows a decrease in left ventricular mass, that s an overall favourable effect on cardiac function with extended haemodialysis. slide 15 That s a small intermezzo, this is a golden key held by Wim Pibjes, who is the director of the Rijksmuseum and this is our former queen Beatrix and the Rijksmuseum was reopened last year after refurbishing and it s very lovely to see so I had to remind you to visit this museum. slide 16

9 9 di 21 But now I ll go on to my key question. What do you regard as proof? I m only sure that answer C. is true and it could be quite relevant of course but of A. and B., there are no randomised trials and I don t think there will be any in the future. So, it depends on you and how much proof you need or do you believe that improvement in soft endpoints is enough. slide 17 Well, let s go onto patient number two and other aspects of in-centre nocturnal. This is my Mr D. 78 years of age. You must have plenty of examples of him in your own population. Diabetes, hypertension, ESRD, compromised vasculature. slide 18

10 10 di 21 In 2010, he came to our centre but he was very difficult to dialyse because he had high blood pressure at the beginning with a high pulse pressure typically but his blood pressure dropped enormously during dialysis and at the end, he had cramps and suffered from vomiting and collapses. slide 19 So, what would you say to him? What is your opinion? Please raise your hand if you say well, you will be less thirsty and have less interdialytic weight gain with three times nocturnal haemodialysis. Who of you says A.? Very few. Or who says you will have less intradialytic hypotension because UF weight is lower with nocturnal haemodialysis? Thank you. Who says C. you will have less intradialytic hypotension because you need less antihypertensive drugs? Thank you. You are very active, you are awake. Well, first the evidence on interdialytic weight gain. slide 20

11 11 di 21 Here I have depicted the interdialytic weight gains that I found in the publications of Ok and Lacson. They compared their two cohorts showing that interdialytic weight gain increases when people go onto nocturnal dialysis, probably because patients restrain themselves less in their fluid intake. I didn t depict Tassin but Tassin has a very low interdialytic weight gain of only 1.6 kg, which they ascribe to a very low salt diet. slide 21 Well, then about blood pressure. The effect on blood pressure is controversial. Some report no difference; others report a decrease in nocturnal haemodialysis. The results on the anti-hypertensives are consistent because nocturnal patients need less anti-hypertensive medication. For example, the Turkish study reported only 8% of their nocturnal patients needed anti-hypertensives versus 22% of patients on conventional dialysis. As for the intradialytic hypotension, there are only descriptions in the literature and not many exact figures. My experience is that you really can encounter low blood pressure during night dialysis but this is mostly because your patient s dry weight has gone up and you had not realised yet or your patient has heart failure and drinks more than 4 litres in two days, so then you could experience some low blood pressure. slide 22

12 12 di 21 I think this is a very instructive slide. Upon starting nocturnal dialysis, we frequently can decrease the dry weight. So we can decrease the dry weight, re-diminish the fluid overload and while the patient continues nocturnal dialysis then he feels better, he eats better, he goes sporting and then his lean body mass goes up and increases like here. So in the beginning there is weight loss and in the end the weight increases while the mean arterial pressure stays perfect. slide 23 Well, all in all, I think that thirst depends on your salt intake and interdialytic weight gain increases with nocturnal dialysis from the data there is so far. B. is definitely true unless your patient manages to drink a can of water, 8L of water. This is an interesting option but the data are lacking. My personal opinion is that we often treat a volume hypertension inadequately with too many anti-hypertensives but in nocturnal haemodialysis you can always succeed in lowering the dry weight and you seldom need the anti-hypertensives but whether this relation is really causal that is difficult to prove if you understand what I mean. slide 24

13 13 di 21 The last patient that I want to present to you for whom I have no slide are the rest of my patients who all eat well and who have hyperphosphatemia, one of the biggest problems in dialysis. This is again Turkey, the two groups of 230 patients. The line represents of serum phosphate which stays the same in conventional and which goes down very quickly with in-centre nocturnal dialysis. When you want to have the mmol/l divide by 3. The bars represent percentage of phosphate binder use. In nocturnal dialysis 40% and in conventional dialysis 55%. There are other authors but who don t have such a beautiful slide but they also report a decrease in phosphate of about 30% and less phosphate binder use except for the US and Canada group who only had a 5% phosphate reduction I found. slide 25 So in conclusion, there are no RCTs comparing conventional with 3 or 4 times 8 hours long due to the fact that patients do not want to enter a randomised trial with important differences in session length and with an option that they have to sleep in a centre. The observational studies with matched comparison could of course, suffer from important inclusion bias because it could be possible that patients agree to a long dialysis programme that those patients are a priori more compliant and therefore, have a better outcome or the other way round that they agree to do long dialysis because they have a fluid problem and have a worse prognosis and we cannot identify those different inclusion biases. It s difficult. So it leaves us with the secondary outcomes of much better hemodynamic and metabolic control and it has convinced me by seeing what happens to my patients and maybe I can convince you a little bit.

14 14 di 21 slide 26 Well, the second part of my talk is on practical problems. This is one of the rooms of our centre where people do not sleep on the wards but have sort of hotel rooms where they do night dialysis. slide 27 These are the points I want to address shortly. As for water treatment, a practical issue regarding the construction of your water system, your reverse osmosis unit and your water piping. Most centres do regular disinfection by ozone or by heat disinfection during the night. So when you start a nocturnal programme, you can only do nocturnal dialysis in the nights that you don t do the heat disinfection or the other way round. slide 28

15 15 di 21 Well, you could choose to construct a parallel system as is shown here. These are three RO units; one of them is always in stand-by so the other two can produce ultra-pure water. What is most important here on the left side there are separate rings so you can disinfect by heat disinfection the separate rings. So then, you have to choose heat disinfection. slide 29 The haemodialysis prescription, most authors, we have seen this already in a previous talk, use a standard dialysate fluid with 2 mmol of potassium, standard calcium. Bicarbonate, you can titrate on your serum bicarbonate. Dialysate flow can be standard or a little bit lower. We used 300 in most patients. Blood flow must be lower than in conventional haemodialysis. We started with 180 for the first weeks of dialysis when people come from conventional and start nocturnal dialysis because otherwise they get headaches by disequilibrium symptoms. Then after a few weeks when they are used to it, then we increase the flow gradually to 200, to 20 sometimes to 50. What s important, you have to subtract 500 ml of your ultrafiltration goal after weighing the patient because of perspiration and loss of fluid through the lungs during the night. slide 30

16 16 di 21 Well, I want to tell you a little bit about anticoagulation. In the US and Canada I think most centres use unfractionated heparin. In Europe, we are using mostly low molecular weight heparins in conventional dialysis. We have some 30 centres doing night nocturnal dialysis in-centre in the Netherlands and we all use the low molecular weight heparin with the following algorithm. At the start of dialysis, the full dose that they also use in conventional dialysis and half way so after 4 hours of dialysis we give an extra half dose. slide 31 We performed a small study in 25 patients comparing two types of low molecular weight: Dalteparin having a half-life of 3-5 hours and nadroparin with a somewhat lower half-life. We measured then during night dialysis the anticoagulation by the level of anti-factor Xa activity. With Dalteparin we reached adequate anti-factor Xa levels that is probably between 0.2 and 0.6 but with long acting low molecular weight heparin, longer acting we see quite high levels of anti Xa at the end of the session when you don t need it anymore. Sometimes sharply anticoagulated. slide 32

17 17 di 21 If we combine the results after 4 and 8 hours and regard this as the target range, then with two doses of Dalteparin, we reached quite reasonable anticoagulation but with nadroparin already after 4 hours, the anticoagulation was a little bit too intense. Well, maybe we could give only one dose of nadroparin but we haven t tried that yet. slide 33 Well, about access care there are a few aspects of access care that was also discussed that I d like to mention. For the needles, we mostly used plastic needles because we think that s safer, we use anti-allergic dressings, we fixate thoroughly by a net bandage or sometimes by a roll around the arm. We use an enuresis alarm in most patients unless they sweat, transpire a lot because then the alarm prevents them from sleeping and that s not what we want. We do either single or double needle dialysis, single for example, when people have an upper arm fistula with a small accessible distance. The puncturing technique, we as doctors prefer the rope ladder technique because we think there s more infection with a buttonhole but the patients are sometimes difficult to convince, they prefer the buttonhole and the nurses do too sometimes. We have problem with the access flow because we don t want to wake up our patients in the middle of the night so we do it at the beginning of the nocturnal dialysis. That s in our centre and there are some other Dutch centres who schedule in every patient dialysis in daytime, for example every 2-3 months and do then the access flow and a talk with the dietician and so on. slide 34

18 18 di 21 Well, then how to guard this night dialysis, the organisation of this supervision that depends on how your centre is organised. If you have all patients on a ward well, then you can look around but we have the centre with separate rooms, 15 separate rooms, we dialyse two times 15 patients during the week. So we have to ensure safety and we have three different alarm systems: slide 35 one conventional system with a beeper for the nurse, one with an alarm system that the nurses in their room can see the alarms on the different monitors and for the third thing, all patients have a telephone so they can ask non-urgent questions. So would you bring me a glass of water or something like that. slide 36

19 19 di 21 Well, other organisational matters, the nurses wear sneakers so as not to wake the patients up. The doctors have to wake up early because we do our rounds a quarter to seven in the morning. slide 37 On top of that, the nurses write down their remarks in a notebook, slide 38

20 20 di 21 which we answer then during the daytime. slide 39 I would like to end with an invitation. If you would like to visit our centre it is just nearby, I could give you a small tour on Monday at lunchtime. Please send me an , then I will let your know the time and the place. Thank you for your time and attention. slide 40

21 21 di 21 Chairman: Thank you, an excellent talk. If there are any questions for Doctor Jaarsfeld? I d like to start the first one please. Do you have any flexibility in the length of dialysis or does everybody have eight hours when they re dialysing in the centre? Dr. van Jaarsveld: No, of course, we have some patients who want to do 7 hours because they have to go to work. There are also some patients who tell me that when they are put on a machine, it takes some time a quarter or half an hour to get to sleep and when they get off, it s eight hours later. So there are some people who do eight and half or nine hours dialysis because they can have a longer sleeping time. Most of them sleep quite well but we have some patients who cannot sleep and who quit the programme then. But we have all sorts of things to make the room dark and to put a towel on top of the screen of the monitor so we have become inventive in that. Question: A related question, do you do alternate nights in some patients? At the beginning, you said you sometimes do three, sometimes four but I can see some organisational difficulties with alternate. Dr. van Jaarsveld: In the Netherlands, most centres started with 4 days a week, so Monday, Tuesday, Thursday and Friday but then they did have the long gap. Most of the centres do that. Well, we became large and we have two shifts, Monday, Wednesday and Friday and Tuesday Thursday and Sunday. The Saturday is off because the nurses wanted that but now there are so many patients who would like to do Saturdays so we are going to start with the alternate day after the summer. So we are very glad we can provide that but there s only one centre in the Netherlands in Groningen, in the north that do alternate day dialysis. I think it s very important to offer that. Chairman: Ok then, Brigit thank you very much for a very clear talk, it s a pleasure for me now to introduce my co-chair James Tattersall. We ve known each other for quite a long time. I think it started off in the EBPG guideline committees some ten or fifteen years ago, I don t remember. Maybe even longer.