NDT Advance Access originally published online on November 19, 2007
Nephrology Dialysis Transplantation 2008 23(4):1313-1317; doi:10.1093/ndt/gfm772
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Prolonged conservative treatment for frail elderly patients with end-stage renal disease: the Verona experience
1 Division of Nephrology, Department of Biomedical and Surgical Sciences, University Hospital of Verona, Verona, Italy 2 Clinical Psychology Unit, University Hospital of Verona, Verona, Italy
Giovanni Gambaro, Divisione di Nefrologia, Dipartimento di Scienze Biomediche e Chirurgiche, Università di Verona, Ospedale Maggiore, P.le Stefani 1, 37126 Verona, Italy. Tel: +39-045-8122521; Fax: +39-045-915176; E-mail: giovanni.gambaro{at}univr.it
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Abstract |
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Background. In frail elderly patients, the chronic use of renal replacement therapy sometimes affords no tangible benefits and may even negatively affect their quality of life (Qol), making prolonged conservative management a reasonable option.
Methods. This observational, uncontrolled study was conducted on 11 end-stage renal disease patients over 75 years of age, on prolonged conservative treatment with a follow-up of at least 6 months, to assess compliance with the Italian clinical guidelines concerning the treatment of renal failure, comorbidities, hospital stays, and several psychometric and Qol indicators in the patients and their caregivers.
Results. We found a substantial compliance with the targets recommended in the guidelines, a moderate tendency for disease progression and satisfactory psychometric and Qol parameters, which proved much the same as those observed in a parallel (uncontrolled) group of patients on haemodialysis.
Conclusions. Our study shows that a conservative strategy is feasible for frail uraemic patients, achieving acceptable clinical results and a Qol comparable with patients on haemodialysis. The study also provides indications on how to plan trials on this topic, to obtain the evidence needed to guide the difficult choice of whether to recommend dialysis or conservative treatment for such frail patients.
Keywords: caregiver; conservative treatment; dialysis; frail; quality of life
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Introduction |
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TopAbstractIntroductionPatients and methodsResults and discussionReferences |
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In routine daily practice, when the time comes to consider dialysis for patients with end-stage renal disease (ESRD), the question is whether a given individual will really benefit from dialysis. In most cases, the answer is simply yes; however in a minority, the patient's age, clinical conditions and level of self-sufficiency make it doubtful whether they will genuinely gain or whether dialysis may be futile or even significantly worsen their quality of life (Qol), or be tantamount to over-medicalizing the dying process [1]. These doubts usually concern ‘frail’ patients, i.e. elderly people over 65 years of age, at greater risk of death or functional decline within a relatively short time [2].
There is no well-established ‘evidence-based medicine’ concerning this aspect of ESRD treatment. The few contributions in the literature deal with very small series, often with a retrospective study design [1,3–5]. To the best of our knowledge, there have been no Italian publications on this issue, but organizational, social and cultural specificities are so relevant to this particular problem that it is hard to import experience gained in other countries. As the US guidelines emphasize [6], given the evolving epidemiological scenario of ESRD, there is a growing need to rely on solid data to decide whether to recommend conservative therapy (CT) rather than chronic dialysis.
This paper reports on the clinical results, disease progression, the burden of care and the patient's Qol at our institution, where a pilot experience has been underway in the past few years with a view to planning a large-scale multicentre study.
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Patients and methods |
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TopAbstractIntroductionPatients and methodsResults and discussionReferences |
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This is an observational study on patients followed up by a single physician at the outpatients clinic of the Nephrology Division of Verona General Hospital between January 2004 and May 2006. To be considered in the analysis, patients had to have the following features: age >75 years; glomerular filtration rate (GFR) below 15 ml/min/1.73 m2; receiving CT despite eligibility for dialysis based on standard accepted criteria; no history of dialysis and a clinical follow-up of >6 months. These criteria were met by 11 patients (4 females), aged 75–88 years.
Our division assures these patients and their caregivers access to a round-the-clock telephone support service, usually provided by the same single physician. Patients and caregivers are told that they can reconsider their choice of CT and switch to dialysis if they wish. The decision to start a prolonged CT (PCT) programme is reached jointly by physician, patient and caregiver. The physician responsible for the outpatients clinic identifies patients suitable for PCT on the strength of personal experience, not on the basis of a previously structured procedure, and objective data, scales or scores.
In addition to treatment required for comorbid conditions, the selected patients were given a typical CT for patients with renal insufficiency, i.e. iron supplementation and erythropoietin therapy, to achieve the haemoglobin concentrations (Hb) recommended in the guidelines of the Italian Society of Nephrology (SIN) (>11 g/dl) [7], plus treatment for secondary hyperparathyroidism and hyperphosphoraemia, as recommended in the guidelines [7]. No dietary restrictions were recommended, except for foods rich in potassium; the diet was supplemented with keto-analogues in a few cases.
Patients had laboratory tests and outpatient visits (always attended by their caregivers) every 4–6 weeks to assess their general condition, to pay particular attention to any cardiovascular problems and to check arterial BP and glucose metabolism. They were given advice on how to maintain water and salt balance, and the medical treatment was revised.
Given the retrospective nature of the analysis, there is no control group. As a rough reference, we simply identified a group of five patients still alive who had been recommended for PCT (by the same physician in charge of the PCT outpatients clinic) during the same time interval, but who had opted instead for haemodialysis (HD).
Data on the patients’ hospital stays were drawn from the hospital and central laboratory databases, recording the periods of time and departments involved, recourse to the casualties department and laboratory test results. We also obtained other information (weight, intercurrent diseases, symptoms and treatment prescriptions) from the clinical records.
A posteriori, the physician calculated the Karnofsky functional score (Ks) at the time of the patient joining the PCT programme; the score was recalculated at the patient's final visit (for patients who died) or latest check-up (for those still being followed up).
Each patient's comorbidities were identified, focusing on the conditions considered in previous studies to indicate frailty [8], i.e. dementia, diabetes mellitus, hypoacusia, heart failure, hypertension, ischaemic heart disease, osteoarthritis, stroke, arrhythmia, urinary incontinence, chronic obstructive lung disease, bedsores, neoplasms and hypothyroidism.
The GFR was calculated using the simplified modification of diet in renal disease (MDRD) formula [9]. In analysing the laboratory and clinical data, particular attention was paid to (1) Hb levels and the use of erythropoietin, and any variations in dosage; (2) blood potassium levels and any use of chelating resins; (3) blood calcium and phosphate levels and any treatment with phosphate binders, calcium supplements and vitamin D, and any variations in their dosage; (4) blood albumin levels (as an index of nutritional status); (5) pressure values and/or variations in antihypertensive medication and (6) variations in diuretic therapy.
We also considered the number of days in hospital, the place where patients died and the cause of death.
At the end of the follow-up, adaptation to the kidney disease and chronic treatment, Qol and family support were investigated by two certified psychologists (GT and CB) in both patients and caregivers, using a semistructured interview concerning personal and family status, lifestyle, experience of disease, type of support received from caregivers, social relations, diet and quality of sleep. None of the patients had cognitive impairments severe enough to make them unable to cope with the tests.
The validated Italian versions of standard questionnaires, e.g. the Beck Depression Inventory (BDI) [10], the Mini Mental State Examination (MMSE) [11] (patients only), the State Trait Anxiety Inventory (STAI-Y 1 and 2) [12], the Short-Form 36 Health Survey Questionnaire (SF36) [13] and the Caregiver Burden Inventory (CBI) [14] (caregivers only) were also administered.
Given the limited number of subjects involved, no formal statistical comparison was performed.
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Results and discussion |
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TopAbstractIntroductionPatients and methodsResults and discussionReferences |
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The demographic and clinical data for the patients on PCT and HD are shown in Table 1. During the study period, five patients (two females) died, two in hospital and three at home. The ultimate cause of death was cardiac-related and stroke in three cases, and uraemia-related in two. There were 17 hospital stays for PCT patients (mean days per patient 10.5, range 2–82) due to heart failure, dehydration and/or diarrhoea, fistula (one case) and drug-resistant hypertension.
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During the follow-up, a modest rise in serum urea (from 28.1 to 34.7 mmol/l) was recorded in all but three patients, but in seven, the concentration at the last check-up was >33.3 mmol/l (200 mg/dl), with peaks of >40 mmol/l in two cases. Serum albumin was not tested routinely to monitor the patients’ nutritional status; two patients needed keto-analogue supplements.
No hyperkalaemia-related problems developed; blood potassium returned to normal during the follow-up in one patient with basal values >6.0 mEq/l. No one needed kayexalate. At the last check-up, potassium was >5 mEq/l in two cases (one a diabetic on treatment with ACE inhibitors).
Mean Hb values were 11.8 g/dl at the baseline and 11.4 g/dl at the end of the follow-up. Apart from three patients with final values markedly lower than at the baseline, all values of others were maintained or improved by erythropoietin therapy (provided in all cases). Only two patients needed blood transfusions. By the end of the follow-up, the therapeutic target recommended in the Italian (SIN) guidelines was not met in four patients.
Mean blood calcium went from 2.20 to 2.25 mmol/l, and phosphate from 1.45 to 1.59 mmol/l. The proportion of patients on target (calcium 2.3–2.6 mmol/l and phosphate <1.77 mmol/l according to the SIN guidelines) rose from 27 to 55% and from 80 to 90% for calcium and phosphate, respectively. The calcium–phosphorus product stayed on target in nine patients (30–55, SIN guidelines).
Almost all patients were taking furosemide at increasing doses to control their fluid balance. They were all receiving cardiovascular prophylaxis with platelet antiaggregants and gastric protection with proton pump inhibitors, and most of them were also on beta-blockers and ACE inhibitors/sartans.
It is worth emphasizing the modest mean decline in renal function during the follow-up: the GFR dropped by a mean 2.4 ml/min/1.73 m2 a year (range 0–6.5), though some patients suffered from an acute deterioration in renal function with a significant drop in GFR, generally caused by dehydration or heart failure. These patients were managed giving priority to their maintenance on the PCT programme, rather than automatically switching them to HD.
Among the six surviving patients (four males and two females) on PCT, the BDI and STAI-Y 1–2 inventories identified three depressed patients and no cases of anxiety. The MMSE identified two patients with a mild cognitive impairment. Among the patients on HD, the BDI identified one patient with depression, the STAI-Y 1–2 revealed no anxiety and the MMSE identified one cognitively impaired patient. Though the small number of patients involved limits the significance of these findings, there was no substantial difference between the two groups.
The patients’ Qol data are shown in Table 2. For the PCT patients, the SF36 test revealed a worse situation on the physical functioning, physical role and emotional role scales than the reference values for age-matched, non-uraemic controls, while higher scores were recorded on the social functioning and mental health scales. The PCT patients’ Qol seemed to be much the same as in the HD group, apart from the physical functioning and emotional role scales, where patients on PCT scored lower. Thus, although the patients on PCT had numerous comorbidities and their functional levels were more severely affected than in the patients on HD, they maintained a satisfactory Qol, particularly in terms of social and mental status. The analysis of the semistructured interviews revealed no marked differences between the two groups of patients or between the two groups of caregivers.
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These observations are important because it has been claimed that the effect of treatment for ESRD patients should be assessed not just in terms of gaining weeks or months of life, but also in terms of Qol, which should be seen as a fundamental measure of the ‘outcome’ [15]. Weisbord et al. [16] found that 68% of patients expressed satisfaction despite achieving no improvement in their symptoms, suggesting that the efficacy of the therapeutic action in this setting has to be seen globally as the sum of qualitative and quantitative results.
PCT does not seem to have a particular impact on caregivers in terms of depression, anxiety and burden of care. The BDI identified one case of depression among PCT patients’ caregivers and one among HD patients’ caregivers. No evidence of anxiety emerged from the STAI-Y 1–2 in either group, and both obtained high CBI scores for ‘objective burden’.
Having to care for a patient on PCT had a negative effect on the caregiver's Qol, especially as concerns the physical role, vitality and emotional role scales (Table 3). The Qol of people caring for PCT patients was much the same as for carers of HD patients; however, except that the former scored better for physical functioning, probably because they were younger (mean age 50.7 years versus 68).
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This study shows that elderly frail patients with ESRD can remain on PCT even when dialysis would generally be recommended.
The study revealed some weaknesses in the organization of our outpatients clinic, i.e. (1) the lack of objective criteria for enrolling patients on a PCT programme; (2) the inadequate monitoring of nutritional status; (3) the shortage of information in the clinical records in some cases and (4) shortcomings in documenting the methods used to inform patients and caregivers and to obtain their consent. This last issue is crucial because on a few occasions it seems to have interfered with the relationship between physician and caregiver, and to have affected the treatment provided by a colleague when the reference physician was absent. Our impression was that decisions concerning the treatment of these frail patients are often ambiguous; some issues go unmentioned, some problems are not thoroughly analysed and key questions are left unanswered, so it is not clear how well the patient's condition, and the implications of a given choice of treatment have been understood.
Since there was no control group, it is impossible to say whether the choice of PCT instead of HD for our group of patients hampered their chances of survival. The study conducted by Smith et al. [5] demonstrated a very modest advantage (with a mean 2-month longer survival) for frail ESRD patients treated with HD by comparison with those on PCT. In contrast, the very recent paper by Murtagh et al. [17] showed no survival advantage of HD over CT in patients over 75 years old with high comorbidity scores.
Our study has a number of limitations that prevent conclusions from being drawn: it was not a controlled, randomized study, but observational and retrospective, and it lacked a control group. It also dealt with a very small number of PCT patients. It nonetheless produced useful indications on how to plan future studies to obtain the information we need to guide frail patients and their caregivers in the difficult choice between dialysis and PCT. Future studies need (1) to be prospective and multicentre to enroll an adequate number of patients; (2) to define the criteria for frailty; (3) to identify clear-cut conditions for recommending dialysis (or PCT) on the strength of a precise, narrow range of GFR values and clinical profiles; (4) to rule out patients recommended for dialysis due to an acute and transient deterioration in renal function; (5) to assess the level of self-sufficiency, functional status, social and family support, and burden of care throughout the follow-up, and to include these issues among the outcomes of treatment; (6) to randomly allocate patients to experimental arms (dialysis versus PCT), while still ensuring that the final decision remains with the patients and their caregivers finally (7) to focus on symptom management, organizational problems and training needs for physicians and nurses dedicated to PCT—an area where it may help to draw from the experience of physicians and operators providing palliative treatment for cancer [18].
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Acknowledgments |
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This study was supported by the Italian Ministry for the University, Cofin 2004 to G.G. The results presented in this paper have not been previously published in whole or part.
Conflict of interest statement. None declared.
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References |
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Accepted in revised form: 4.10.07
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