NDT Advance Access originally published online on September 25, 2006
Nephrology Dialysis Transplantation 2006 21(12):3506-3513; doi:10.1093/ndt/gfl487
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Long-term survival rates in haemodialysis patients treated with strict volume control
1Department of Nephrology, Ege University Medical Faculty Nephrology, 2Department of Medical Statistic and 3Department of Nephrology, Affiliated Private Dialysis Center, Bornova, Izmir, Turkey
Correspondence and offprint requests to: Mehmet Özkahya, Ege Üniversitesi T
p Fakultesi, Iç Hastaliklari Nefroloji Bilim Dali, Bornova-35100 Izmir – TURKEY. Email: ozkahya65{at}superonline.com
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Abstract |
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Methods. We analysed the survival of 218 patients (132 male, 86 female, age 48 ± 15 years) who were treated in our dialysis units since we adopted the strategy of strict volume control without antihypertensive drugs. The mean observation period was 47 ± 34 (6–140) months. Follow-up was ended because of death (57 patients), transfer to another center (35 patients), continous ambulatory peritoneal dialysis (CAPD) (15 patients) or transplantation (23 patients), while 88 were still under our treatment at the time of writing.
Results. Blood pressure (BP) decreased from a mean of 150 ± 31/89 ± 16 at the start to 121 ± 14/75 ± 8 mmHg at the end of observation (P < 0.001). Only nine patients needed a drug (enalapril) to reach this goal. Cardiothoracic index (CTI) dropped from 0.50 ± 0.06 to 0.46 ± 0.05 (P < 0.001). Interdialytic weight gain decreased from 1440 ± 360 to 930 ± 240 g/day (P < 0.001). Mortality rate was 68, 2 per 1000 patient-years, better than in most published series. There was a striking influence of age, but also of CTI and systolic BP on survival rate. Patients with CTI 
0.48 showed mortality 3.8 times higher than CTI < 0.48 (log rank P < 0.001). Consequently, the mean CTI of the deceased patients was much higher (0.50) than the average of the group (0.46) while their mean BP (123 ± 16/75 ± 9 mmHg) was not significantly different from the other patients. We found no increased mortality at low–normal pressure levels (systolic BP between 100 and 130 mmHg), but mortality was increased in small groups of patients whose pressures were lower or higher than these values. Thus, the curve, relating mortality to blood pressure was shifted markedly to the left.
Conclusions. These results strongly suggest that the strategy of ‘volume control’, also when applied with conventional dialysis times, normalizes BP and increases survival of dialysis patients. Cardiomegaly, as evidenced on the chest X-ray despite normal BP, had a strong negative influence on survival. The large majority of the patients had low–normal BP after long periods of treatment and showed the lowest mortality, favouring the view that target BP should be lower than advised by most authors.
Keywords: blood pressure; cardiothoracic index; haemodialysis; survival; volume control
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Introduction |
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In a non-dialysis population, hypertension (HT) is an established risk factor for myocardial infarction, cerebrovascular accidents and death [1,2]. Large trials have also shown decreases in morbidity and mortality after antihypertensive treatment.
In haemodialysis (HD) patients, HT is extremely frequent. Recent reports from Europe and the United States show a prevalence of HT between 70 and 90% [3]. However, studies relating mortality rate to blood pressure (BP) level are controversial.
Cardiovascular disease is a major cause of death in these patients and estimated to be 10–20 times higher than that in the general population. Most studies also reported that the increased mortality and cardiovascular complications are related to increases in systolic as well as diastolic BPs (SBP, DBP) [4]. However, recent studies concluded that HT has little or no relation at all to mortality, casting doubt on the desirability of HT treatment in these patients. Indeed, proof that lowering BP in patients reduces mortality is still lacking. Zager et al. [5] reported a J- or U-shaped association of BP and mortality in the HD population, as both low and high BP were associated with reduced survival [5]. Other authors also found that survival was lower at pre-dialysis SBP < 120 mmHg [3,6].
In contrast, Charra et al. [7] were able to reach good BP control without antihypertensive drugs, together with very low mortality in a large group of HD patients. They also reported that survival in this group was 20% better if mean pre-dialysis arterial pressure (MAP) was <98 mmHg than when it was above this value. Thus, death rate was reduced with lower BP values even within the normal range. The authors used very long dialysis sessions and attributed these good results to careful attention of the dialysis team to a salt-restricted diet and volume control, although other factors related to long dialysis time (and consequently high Kt/V values) could not be excluded.
We have previously shown that good BP control [8] and regression of left ventricular hypertrophy [9, 10] can also be achieved with conventional dialysis times provided that similar attention is given to salt restriction and volume control.
The aim of the present study was to analyse the survival of all the patients who came under our care since we started the aforementioned treatment strategy around 12 years ago. We also analysed the relation between cardiothoracic index (CTI) and mortality rate. In addition, we investigated whether there is also a U-shaped relationship between BP and survival with this treatment.
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Patients and methods |
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At the start of our study, 42 patients attended the regular dialysis programme. During the following years, 176 more were admitted. We prospectively studied these 218 patients (86 females, 132 males). Among them, 18 were found to have pre-existing valvular disease or angiographically proven coronary disease (sometimes requiring surgical intervention). Diabetic nephropathy was present in 24 (11%) patients.
The 42 patients present at the start of the study had been treated for a mean 27 ± 18 months. As many of the newly admitted patients were clearly over-hydrated, they entered the study after this fluid excess had been corrected. Thus, follow-up was started 1–10 weeks after the start of dialysis treatment in this group. During the follow-up period (mean 47 ± 34, ranging from 6 to 140 months), 130 patients left our dialysis centres (Ege University Dialysis Center and Affiliated Private Dialysis Center) because of death (n = 57), transplantation (n = 23), transfer to CAPD (n = 15) or to another centre (n = 35). At the time of writing, 88 patients are still being followed.
Treatment schedule
We started a programme consisting of re-emphasis on salt restriction, stopping all antihypertensive medication, intensified ultrafiltration (UF) during dialysis and occasional isolated UF sessions.
Haemodialysis with UF was applied three times a week for 4 or 5 h. If too much weight was gained, an extra isolated UF session was added. This was necessary in 28% of the patients. Fifteen patients had to be hospitalized for some days to get better control. This also acted as a kind of sanction. The aim of our treatment was not only to normalize BP, but also to achieve cardiac dimensions as close to normal as possible. These efforts were continued for prolonged periods and were only given up when it proved to be impossible to reach these goals. Mean Kt/V and URR were 1.3 ± 0.12 and 63 ± 7%, respectively throughout the study.
Captopril test
If BP remained >140/90, but we were in doubt whether normovolaemia was reached because CTI was close to normal (< 0.50), we used a ‘captopril test’ to evaluate the ‘renin-dependency’ of the BP. This test was performed on a non-dialysis day. BP was taken at 10 min intervals with an automatic machine in a quiet room for 1 h before and at least 90 min after consuming a tablet of 25 mg captopril. When BP did not drop, UF was continued. The test was considered positive when DBP dropped more than 10 mmHg. In that case enalapril treatment was started. Sometimes it was possible to stop that drug after some weeks or months without a rise in BP.
Diet
We advised a salt-restricted diet. Because this matter had often been neglected previously, repeated instructions by doctors or nurses, written or oral explanation on the meaning of salt restriction and interviews by a dietician were necessary to change the patient's attitude. It was explained by the dialysis team that water restriction alone is ineffective as long as salt is not restricted and the patients were advised to drink not more than their thirst indicated. From the analysis of their food consumption, dietary sodium chloride content was estimated to be around 70 mmol/day, corresponding to a mean salt intake of 4–5 g/day. Normal to high (1–1.2 g/kg body weight/day) protein diet was prescribed. The habit to allow liberal meals during dialysis was abolished.
Blood pressure (BP) measurement
Pre-dialysis BP levels were measured in every session with a manual sphygmomanometer. An experienced nurse took the measurements in the non-fistula bearing arm with the subject in the seated position after 5 min rest. BP values given in this article are the mean of at least six consecutive pre-dialysis recordings. Hypotension was defined as a decrease of BP >30 mmHg systolic that caused complaints of dizziness and nausea requiring intervention with saline infusion or termination of UF.
Interdialytic weight gain is given as the mean of six consecutive periods.
CTI was calculated from a 2-m chest X-ray. The largest horizontal diameter of the heart was divided by the largest inner diameter of the thorax wall. We measured CTI at the beginning of the observation and then two to four times per year. When hypervolaemia was suspected, additional X-rays were performed.
Erythropoietin treatment combined with iron was given to all patients with haematocrit <30%. In order to maintain values between 30 and 33%, 54% of the patients needed this treatment. We did not observe any untoward effect on BP.
Statistical analysis
The Kaplan–Meier method determined actuarial survival rates. A log-rank was used to compare the different survival curves. The patients were censored at transplantation, transfer to HD or other centres, or at the end of the observation period. Forward stepwise multiple Cox analysis was used to identify factors predicting patient mortality and risk ratios (RRs) for mortality in study groups. Data are presented as mean ± SD. The difference was considered significant when the P-value was <0.05. The study group was analysed by means of an unpaired Student's t-test for quantitative variables.
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Results |
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The age of the patients at the initiation of dialysis was 48 ± 15 years (17–86 years). Renal diagnosis, age distribution, BP and CTI at the start of follow-up are shown in Table 1. Seventy-two patients (33%) were normotensive (<140/90 mmHg) or became so within the first few weeks. The mean duration of the follow-up period was 47 ± 34 (6–140) months.
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At the end of the observation period, BP was well controlled in nearly all patients (Figure 1), while interdialytic weight gain decreased from 1440 ± 360 to 930 ± 240 g/day. In only 10 patients did SBP exceed 140 mmHg. Nine patients (4%) finally needed enalapril to keep the BP normal. As shown in Table 2, mean pre-dialysis BP decreased from 150 ± 31/89 ± 16 to 121 ± 14/75 ± 8 mmHg. BP values obtained after 3, 12 and 24 months were 136 ± 31/79 ± 14, 117 ± 16/77 ± 8, 118 ± 13/74 ± 7 and 120 ± 11/75 ± 6 mmHg respectively.
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The percentage of patients with CTI
0.48 decreased from 66 to 33%, and mean CTI decreased from 0.50 ± 0.06 to 0.46 ± 0.05. Echocardiography was not performed systematically, but results are available of 105 patients, obtained between 8 and 105 months after the start of the observation, when BP was well controlled. Left ventricular hypertrophy was present in 66% of 27 patients who died, while it was 23% in 78 surviving patients. CTI was significantly correlated with left ventricular mass (LVM), left ventricular end diameter, left atrium diameter (Pearson and Kendall correlation test, P < 0.01). In Table 3, we show the available echocardiographic results in the patients separated into groups according to the SBP levels. There was a clear tendency for the LVM and CTI to increase in those with higher BP levels. This did not hold for the very small group with abnormally low BP, due to the presence of one patient with evident dilated cardiomyopathy. If this patient is excluded, results of the remaining three patients fit into this tendency.
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In Table 4, we separated the patients into a group with normal and one with elevated CTI at the end of the follow-up. BP was not significantly higher in patients with cardiomegaly. Among the 66 patients with increased CTI, 20 had cardiac disease proven by echocardiography (Table 5).
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Fifty-seven patients died after a mean follow-up period of 41 ± 31 (6–132) months. Their mean age at the time of death was 62 ± 12 years. Their mean BP at that time was 123 ± 16/75 ± 9 mmHg, not different from the rest of the group. However, their CTI was significantly higher (0.49 ± 0.05) than that of the other patients.
Survival rate
The Kaplan–Meier survival data of all the 218 patients subdivided according to age is shown in Figure 2. The survival was shorter in patients starting HD at an older age (age <45 years vs age 45 years, log rank P < 0.001). In Figure 3, we subdivided the survival rates according to CTI. Five-years survival was 88% in patients with normal CTI, but only 54% in those with CTI 0.48 (CTI < 0.48 vs CTI 0.48, log rank P < 0.001).
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Forward stepwise multiple Cox analysis of patient survival is reported in Table 6. The age at the start of HD, their CTI (
0.48) and pre-dialysis SBP during follow-up are the three most important cofactors linked to survival. Mortality of patients with a CTI 0.48 was 3.84 times higher than of those with a CTI < 0.48 (P < 0.001).
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Of the 18 patients who had organic cardiac disease at the start of observation, 15 died. Of the 24 patients with diabetes, 13 died; as did four out of the six patients with amyloidosis. Thus, more than half of the 57 deceased patients had some additional disease.
In a further analysis of the relationship between BP level and mortality, we stratified the deceased patients into groups according to their final SBP (Figure 4). This figure suggests a ‘U-shaped’ relationship. An increase in mortality per 100 patient-years mortality was present in a small group of 20 patients with very low SBP (<100 mmHg) and in the somewhat larger group of 40 patients with moderately elevated SBP (between 130 and 150 mmHg). In none of our patients did BP exceed that value. The majority of the patients (71%, whose SBP values were between 100 and 130 mmHg) showed a mortality of <7/100 patient-years. The lowest mortality was present in the group with systolic pressures between 100 and 110 mmHg.
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While clear complaints of congestion were seldom present, many patients experienced increased well-being when weight loss was achieved. Acute pulmonary oedema necessitating hospital admission occurred in five patients during the first months, but was not seen during the last years due to more strict supervision. Digitalis alkaloids were given to only one patient for arrhythmia.
Residual renal function
Urine production, if present, usually decreased with time. At the end of the observation, nearly all of the patients were anuric, or produced <200 ml, while urine production at the start had varied between 0 and 1500 ml/day.
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Discussion |
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TopAbstractIntroductionPatients and methodsResultsDiscussionReferences |
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Our results show that it is possible to achieve good BP control and survival in HD patients by the described method of ‘volume control’. They are comparable with those of Charra et al. [7], but these authors used long dialysis sessions. We obtained similar results with conventional dialysis times, suggesting that volume is the main determinant of survival and that Kt/V and other factors related to dialysis time are of relatively minor impact. It is of note that not only cardiovascular mortality but also to a lesser degree, death from other causes was lower than in most other series. This is not surprising since most complications in dialysis patients are multifactorial, and the general well-being was often better after good volume control.
Using the strict volume control treatment, we previously found impressive improvement in BP control [8], general well-being and left ventricular hypertrophy [910]. We therefore did not want to constitute a control series from our own patients because we would have to deprive them of the treatment that was superior, in our opinion.
The overall, as well as the cardiovascular, mortality rates of our patients were lower than those reported by most US, European and Turkish dialysis registries [11–13]. They are comparable with those of Elinder et al. [13] (Table 7). In that series, survival of the group aged 40–49 was somewhat better than ours; but in the older patients and those with co-morbidity as well, our results were better on the whole. It should be remarked that, due to the design of our study, 20% of the patients had been longer on dialysis treatment than the time used to calculate survival. Thus, real survival was longer.
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It is not possible to conclude that these good survival figures are due to the applied method of treatment because of a different ‘patient mix’. For instance, in most of these series, mean age as well as the percentage of diabetic patients was much higher. In the study of Port et al. [6], 35% of the patients were diabetics, as compared with only 11% in our study. The group that is most comparable with our series is the one of Turkish patients from the Istanbul University published by Oygar et al. [14]. In that series, the mean age was slightly younger (45 years) than of our patients, but the 5-year survival was only 42% compared with 76% in our series. BP in that study was 145/87 mmHg, and there was a strong correlation between BP and mortality (Table 8).
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Earlier reports on HD patients suggested that BP was refractory to treatment in only 10% of the patients, and that these patients may become normotensive after nephrectomy or renin-angiotensin lowering drugs. For unclear reasons, more recent surveys indicate that BP remains elevated in much larger proportions of dialysis patients [3]. It is interesting therefore that only 8% of our patients’ BP proved refractory to strict volume control. Eight patients had a final BP over 140/90, and nine required a drug (enalapril). This was the only drug used. We have previously reported and discussed this discrepancy [10].
There was a tendency for the BP to decrease further with time, resulting in a final SBP between 100 and 120 mmHg in more than half of the patients. The fact that the mean SBP level of the 57 deceased patients was not significantly lower than that of the other patients does not support the contention [5] that low BP levels are particularly harmful.
Yet, we also found a ‘U-shaped curve’ (Figure 4). However, increased mortality was only seen with abnormally low (<100 mmHg) and moderately elevated SBP levels. Thus, the position of the curve compared with the reports of Port et al. [6] and Zager et al. [5] was shifted to much lower values.
Comparison of our results with those of others is hampered by the fact that serious hypertension was absent in our patients. Tomita et al. [15] reported that survival was better if SBP could be lowered to levels <160 mmHg, but none of our patients’ BP exceeded that value. Surprisingly, Salem [16] found an inverse relationship between mortality and BP. Zager et al. [5] showed lower mortality rates with higher levels of BP. Patients with BP <120/80 mmHg had even 2.5 times increased mortality risk. This sharply contrasts with our series, where patients with SBP between 100 and 120 mmHg had the lowest mortality in per 100 patient-years (about 4%) during 47 ± 34 (6–140) months of follow-up.
In an analysis of a random sample of 4499 US HD patients, Port et al. [6] also found an increased risk for patients with SBP<119 mmHg, while there was no increase in mortality risk even at levels >180 mmHg. It should be remarked, however, that the patients in this group were much older (53% of his patients were >60 years of age, as compared with 27% of our patients), as was the proportion of diabetics (35.7%).
Another group of investigators [4] reported that elevated BP was associated with worsening of echocardiographic findings and clinical deterioration, but that mortality was associated with low BP. They attributed this paradoxical result to the high prevalence of cardiac failure in their series, which preceded death in 65% of the cases. They therefore advocate MAP levels <98 mmHg to prevent cardiac failure, but it was unclear from that study which should be the target once heart failure occurs. In our experience, tight volume control is even more desirable after a congestive episode. With the ‘volume control’ strategy we applied, congestive heart failure was not seen at all after the initial phase.
Our results, therefore do not support the suggestion [6] that low BP levels in general are to be viewed with great concern, but rather that normal-to-low values may be advantageous, as long as they are reached gradually over prolonged periods. Even more caution has to be taken in the high-risk patients who formed the majority in Port's group, but our experience does not suggest that treatment principles should be different in such patients.
A crucial question regarding our approach is how to determine the ‘dry weight’. In our opinion, no method, even impedance measurement, is suitable for clinical practice. First, because of biological variability, their range of error is of the same order of magnitude as the volume changes which determine the difference between hyper- and normotension [17]. We found the described ‘captopril test’ particularly helpful. An elevated BP (not reactive to captopril) is a sign that dry weight has not been reached.
The second reason is the time factor. We agree with Charra and coworkers [7], that it may take weeks before BP adapts to a new steady state. This ‘probing for dry weight’ is a difficult time for both the patient and the dialysis team. If they are not convinced by previous experience that success will ultimately be achieved, they will give up too early. This is certainly the reason why the majority of dialysis patients all over the world are still hypertensive despite massive application of antihypertensive drugs. It should be stressed that to reach this goal, intense individual coaching for salt restriction of the patient and his family is necessary. In order to persist ultrafiltration sessions, the whole team, in particular, the nurses, have to be convinced of their necessity. In the beginning, they are often interrupted because of hypotension and cramps, which do not prove that dry weight has been reached. These problems and their pathophysiological background are more extensively discussed elsewhere [8–10].
In accordance with our previous experience, we used the CTI as an additional parameter during the follow-up. CTI gives only gross information about the condition of the heart and cannot be used to exclude small degrees of dilation. However, if a patient has hypertension and the CTI is above normal limits, it is a strong argument to pursue vigorous ultrafiltration. If the BP is normal, an increased CTI is a sign of cardiac disease, but still does not exclude overhydration. A striking example was published previously [18]. In case of doubt, we always used echocardiography, but such data were not available from all patients and are therefore not presented here. However, we found chest X-rays to be suitable not only to detect pulmonary congestion, but also to evaluate changes in an individual patient, and therefore use them as a routine. In addition, there was a clear tendency for the LVM and CTI to increase with higher BP levels in the patients whose echocardiographic results were available (Table 3). We previously demonstrated that regression of the LVM index (LVMI) was associated with reduced CTI and lower BP [9,10]. Harnett et al. [19] showed also that SBP was significantly and independently associated with increased LVMI.
For our analysis (Table 6), we arbitrarily chose a value of 0.48 to separate the patients into two groups, because in our experience values above this level are nearly always associated with some dilatation on echocardiographic examination. Of course, normal CTI generally is well below that value.
While at the start of dialysis treatment BP was often related to the CTI in individual patients, it is clear from Table 2 that no such relation was seen at the end of the follow-up. We interpret this finding as suggesting that these high final CTI values were due to intrinsic cardiac damage and (in view of their low BP values) could not be improved by further ultrafiltration. This is supported by the strong relationship between CTI and survival (Figure 3).
In conclusion, the results of this prospective study are highly suggestive of a beneficial effect on survival of low–normal BP achieved with ultrafiltration and salt-restricted diet, as recently advocated by Mailloux [20], while avoiding hypotensive drugs as much as possible. They support the recent recommendations of the ISH (target pressure of 120/80 mmHg) also for dialysis patients.
Addendum
In Turkey, acceptance to dialysis is open to anybody and there were no age or diagnosis restrictions when we started this study.
Conflict of interest statement. None declared.
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Accepted in revised form: 20. 7.06
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