Metabolic effects of cholecalciferol supplementation in patients with calcium nephrolithiasis and vitamin D deficiency.

INTRODUCTION: In this paper, we investigated whether cholecalciferol supplementation may increase the risk of stone recurrence in patients with calcium nephrolithiasis and Vitamin D deficiency. METHODS: Thirty-three stone formers (56 ± 17 years old, 12 males) with 25(OH)D < 20 ng/mL were considered. Calcium excretion and urine supersaturation with calcium oxalate (ßCaOx) and brushite (ßbsh) were evaluated, both before and after cholecalciferol supplementation. Values of ß > 1 mean supersaturation. Cholecalciferol was prescribed as oral bolus of 100,000-200,000 IU, followed by weekly (5000-10,000 IU) or monthly (25,000-50,000 IU) doses. Calcium intake varied between 800 and 1000 mg/day. In urine, total nitrogen (TNE) was taken as an index of protein intake, sodium as a marker of dietary intake, and net acid excretion (NAE) as an index of acid-base balance. RESULTS: TNE, sodium, and NAE did not change during the study (p = ns). Compared to baseline values, after cholecalciferol, both serum calcium and phosphate did not vary (p = ns); 25(OH)D increased from 11.8 ± 5.5 to 40.2 ± 12.2 ng/mL (p < 0.01); 1.25(OH)2D increased from 41.6 ± 17.6 to 54 ± 16 pg/mL (p < 0.01); PTH decreased from 75 ± 27.2 to 56.7 ± 21.1 pg/mL (p < 0.01); urinary calcium increased from 2.7 ± 1.5 to 3.6 ± 1.6 mg/Kg b.w. (p < 0.01); ßbsh increased from 0.9 ± 0.7 to 1.3 ± 1.3 (p = 0.02); whereas ßCaOx varied but not significantly. Before cholecalciferol supplementation, 6/33 patients were hypercalciuric (i.e., urine Ca ≥ 4 mg/Kg b.w.) and increased to 13/33 after cholecalciferol supplementation (pX2 = 0.03). CONCLUSIONS: Cholecalciferol supplementation may increase calcium excretion, or reveal an underlying condition of absorptive hypercalciuria. This may increase both urine supersaturation with calcium salts and stone-forming risk.

[Metabolic effects of Cholecalciferol supplementation in kidney stone formers with vitamin D deficiency].

INTRODUCTION: In this paper we investigated whether cholecalciferol supplementation, prescribed to treat vitamin D deficiency in patients with nephrolithiasis, increased the risk of stone recurrence. METHODS: Calcium excretion and urine supersaturation with calcium oxalate (ßCaOx) and brushite (ßbsh) were evaluated in 33 kidney stone formers (aged 56±17; 12 males), both before and after therapy with cholecalciferol, prescribed as oral bolus of 100.000-200.000 UI, followed by maintenance doses, repeated every week (5.000-10.000 UI) or month (25.000-50.000 UI). During the study, patients followed a dietary regimen which included a daily calcium intake of about 800-1000 mg. RESULTS: Urinary nitrogen, sodium and ash-acid excretion did not significantly change during the study. After cholecalciferol supplementation, the main results were as follows: both serum calcium and phosphate did not vary significantly; 25(OH)VitD3 increased from 11,8±5,5 to 40,2±12,2 ng/mL (p<0,01); 1,25(OH) 2 VitD3 increased from 41,6±17,6 to 54,0±16,0 pg/mL (p<0,01); PTH decreased from 75,0±27,2 to 56,7±21,1 pg/mL (p<0,01); daily urinary calcium increased from 2,7±1,5 to 3,6±1,6 mg/Kg b.w. (p<0,01), whereas fasting urinary calcium did not change significantly. After therapy, ßbsh increased from 0,9±0,7 to 1,3±1,3 (p=0,02) and ßCaOx did not vary significantly. Before cholecalciferol supplementation, 6/33 patients (18.2%) were hypercalciuric, whereas 13/33 patients (39,4%) showed hypercalciuria after supplementation (pX²=0,03). CONCLUSIONS: Cholecalciferol supplementation for vitamin D deficiency may increase both urinary calcium and urine supersaturation in stone formers. If vitamin D supplements are needed in these patients, a careful monitoring of urine metabolic profile is warranted, in order to customize the metaphylaxis accordingly (hydration, potassium citrate, thiazides).

[The "Nephrology outpatient Triage": an organizational model for the ambulatory care of patients with advanced renal disease].

The clinical course of outpatients with advanced chronic kidney disease requires a close monitoring by the nephrology team, in order to identify emerging clinical problems promptly and prevent subsequent complications. With the aim of improving the outpatient management in our clinic dedicated to advanced renal failure, we implemented the "Nephrology Clinic Triage" (NCT). This organizational model is coordinated by the nephrologist and supported by nurses. In case the outpatients, or their caregivers, have clinical problems or need advice, they can easily get in touch with a nephrology nurse by a dedicated telephone line. The nurse, who had been specifically trained for this purpose, interviews the patient by telephone and track his health conditions using dedicated flow-charts. The patients must be able to answer in a suitable way to the telephone interview on which NCT is based. Therefore, all patients referring to nephrology clinic are trained to record and report properly by telephone some relevant clinical parameters (i.e., blood pressure, body temperature, heart rate, body weight, urine volume) and clinical signs (dyspnea, dysuria, diarrhea, nausea, vomiting, abdominal/lumbar/chest pain). On the basis of the information obtained by means of NCT, the nurse can identify the patient's need and classify its severity and priority by means of a color-coding system. The subsequent medical intervention (telephone conversation, scheduled appointment, hospitalization) is planned accordingly. The implementation of NCT may be useful to monitor the clinical course of outpatients with advanced chronic renal failure also when they are home, thereby reducing the risk of harmful complications and hospitalization.

Guidelines audit may overcome disparities in health care: experience of an Italian region.

BACKGROUND: A clinical audit is used to verify the application of evidence-based clinical guidelines. Our regional section of the Italian Society of Nephrology was the first to establish a region-based program of clinical audits of compliance with guidelines for treating osteodystrophy and anemia of patients on chronic dialysis. This study summarizes the main results of the 2 audits of the Piemonte region. METHODS: Structured questionnaires were sent twice to all of the 22 dialysis centers of Piemonte and to the Center of Valle D'Aosta for an Audit on Osteodystrophy (in 2000 and 2004) and for the Audit on Anemia (2003). The questionnaires were meant to evaluate the clinical schedule of treatment relative to calcium-phosphate balance and anemia in dialysis patients. RESULTS: All centers responded, showing low levels of agreement with the targets of Italian guidelines. In sum, in 2000 only 27% of centers had more than 70% of patients with serum phosphate <5.5 mg/dL, but that rate had increased to 33% in 2004. Only 35% (in 2000) and 40% (in 2004) of the centers had more than 90% of patients with Kt/V >1.2. The Audit on Anemia showed a median of 42% of patients with hemoglobin between 11 and 12 g/dL, and only 2 centers had more than 70% of patients above this target. CONCLUSIONS: The first result of our pioneering experience was that we found that compliance with minimal levels of care was still inadequate, with regard to hyperphosphatemia, dialysis adequacy and anemia. Nevertheless, the 2nd Audit on Osteodystrophy showed a relative improvement in the results. But, most importantly, this open regional report has encouraged comparisons, and motivated centers to adopt a strategy of understanding, addressing and correcting inadequate levels of care, and furthermore increased satisfaction with the care being offered.

[The Hyperoxalurias]. / Le iperossalurie.

Oxalate (Ox) is an end-product of metabolism, important for poor solubility of its calcium salt in biological fluids. Ox can therefore be found in about 70% of urinary calculi. Hyperoxaluria (HOx) defined as Ox exceeding 0.5 mmol)/day, may cause nephrolithiasis/nephrocalcinosis and may be classified as dietary (DH), enteric (EH) or primary (PH). Fractional intestinal absorption of Ox is less than 10%, but increases to over 20% at calcium intakes below 200 mg/day. DH is often related to low-calcium diets. EH is caused by non-absorbed fatty acids which bind to calcium and lower its concentration in the intestinal lumen. Ox forms more soluble complexes with other cations and results in HOx. Similar mechanisms may cause HOx following bariatric surgery. PHs are the most severe causes of HOx. Three types have so far been described, all being autosomic recessive. PH1 is due to mutations of AGXT gene encoding liver alanine-glyoxylate aminotransferase, PH2 is caused by mutations of GR-HPR gene encoding glyoxylate reductase and PH3 by mutations of HOGA1 encoding for hydroxyl-oxoglutarate aldolase. HOx results from deficient detoxification from glyoxylate, which is oxidized to Ox. The three PHs have different severity, though not always clinically distinguishable. They are identified through genetics and, in PH1, good genotype/phenotype correlations have been established. Thanks to early biochemical and genetic diagnosis, which are crucial to either prevent progression to ESRF or choose adequate transplantation strategies, the outlook of PH patients has dramatically improved in the last decades and will furtherly do in view of new therapeutic strategies.

[The effects of Cinacalcet in renal stone formers with primary hyperparathyroidism]. / Effetti del Cinacalcet sulla biochimica urinaria e il rischio litogeno in pazienti con Iperparatiroidismo Primitivo e calcolosi renale.

Primary hyperparathyroidism (PHPT) may favor nephrolithiasis mainly through an increase in calcium and phosphate urinary excretion. Cinacalcet exhibits good efficacy to control hypercalcemia in PHPT, but it is not so far known whether it might be a useful tool to prevent stone recurrences. Of 67 patients with PHPT and recurrent nephrolithiasis, 55 underwent parathyroidectomy (PTX) and 12, not eligible to PTX, were prescribed Cinacalcet. All the patients were evaluated for mineral metabolism, including estimation of state of saturation for calcium oxalate (CaOx) and brushite (bsh), both at baseline and after either PTX or Cinacalcet. PTX compared to baseline reduced PTH (4617 vs 15786 pg/mL, p<0.01), calcemia (9.40.5 vs 11.30.9 mg/dL, p<0.01), calciuria (3.62.3 vs 9.24.5 mmol/24h, p<0.01), phosphaturia (18.47.1 vs 21.99.9 mmol/24h, p<0.05), CaOx (4.73.9 vs 9.86.8, p<0.01) and bsh (1.10.9 vs 3.22.2, p<0.01). Cinacalcet decreased both PTH (13379 vs 17187 pg/mL, p<0.05) and calcemia (9.70.6 vs 11.20.8 mg/dL, p<0.001), whereas no change was seen in calciuria (7.42.2 vs 7.42.4 mmol/24h, p=ns), phosphaturia (21.97.3 vs 23.06.5 mmol/24h, p=ns), CaOx (6.92.7 vs 5.42.5, p=ns) and bsh (1.71.1 vs 1.31.3, p=ns). We conclude that in patients with PHPT, PTX is able to decrease the risk for crystallization of calcium salts, whereas calcimimetic Cinacalcet did not. Therefore, in patients with PHPT complicated with nephrolithiasis only PTX can improve urine biochemistries thereby reducing the risk for recurrent calcium stone disease.

Home hemodialysis à la carte: a tailormade program (1998-2003).

BACKGROUND: There are good epidemiological (increased numbers of dialysis patients), economical (renal replacement therapy (RRT) costs) and clinical reasons (new highly efficient schedules) to reconsider the choice of home hemodialysis (HD). STUDY AIM: Analysis of the results and costs of a flexible, tailormade home dialysis program (1998-2003). SETTING: Home HD facility of the University of Turin-Italy. METHODS: Results were analyzed in terms of feasibility (enrolment rate, logistical problems--the two usual caregivers performed a retrospective analysis of the clinical records; production costs, assessed with a logic bottom-up technique). Since the main program feature was the tailoring of dialysis to the patient, kinetic data were analyzed to control the efficiency of the chosen schedules. RESULTS: In 1998-2003 (54 months), 31 patients joined the home HD program (six patients were already being treated), while another 12 patients were treated in the training area and trained for an ongoing self-care program; mean age was 47.1 +/- 12.8 yrs; 35/49 patients had clinical comorbidities. During the study, four patients died, 10 were grafted, and six patients dropped out or were transferred. In March 2003, 23 patients were at home/in training and six were being treated in the training area: 11 patients were on a conventional schedule, four on daily dialysis, 12 on other schedules (two patients non-resident in the Piedmont region were not considered). Dialysis efficiency reached the target (EKRc > 11 mL/min) in all but four patients (schedules with more frequent sessions were planned for these patients). Costs were comparable to limited care HD (daily: 96.5 euros/session at home, 98.76 euros/session in the center; conventional: 133.48 euros/session at home, 131.25 euros/session in the center). CONCLUSION: A tailored, flexible policy can help to revive a home HD program.

Flexibility as an implementation strategy for a daily dialysis program.

BACKGROUND: Daily hemodialysis (DHD) is an interesting dialysis option, experienced worldwide by only a few hundred patients, because of clinical and logistic limitations. This study describes the main clinical and implementation results of a flexible policy applied in starting a DHD program. METHODS: The setting is the University Nephrology Center of Turin, Italy (approximately 150 hemodialysis and 50 peritoneal dialysis (PD) patients) where in November 1998 a short daily DHD program was started. Outcome measures were logistical (enrollment rate, indications and drop-outs) and clinical (dialysis efficiency, metabolic control, hypertension and anemia control). RESULTS: 25 patients experienced DHD, 16 (11% of the hemodialysis pool) were on DHD in November 2001; overall the DHD follow-up was 409.1 months (median 18, range 0.7-36 months). Flexibility was applied to schedules (patients modulated dialysis time and could switch to 3-4 sessions/wk); treatment setting (home: 11 patients, limited care center: 13; alternate settings: one); clinical selection (23/25 patients with comorbidity). Main reasons for choice were poor tolerance of previous schedule and the search for "best" treatment. Five patients dropped out (work reasons), one died on DHD and three were grafted. As compared to baseline, dialysis efficiency increased (EKRc pre-DHD 14.5 +/- 2.1 mL/min; 17.4 +/- 2.8 mL/min and 17.7 +/- 3.5 mL/min at 1-6 months; p<0.000). Despite the potentially confusing effect of comorbidity, the main clinical data improved. CONCLUSIONS: A flexible approach allowed development of DHD in approximately 11% of hemodialysis patients, with promising clinical results, despite frequent comorbidity.

Kidney rupture: an unusual and oligosymptomatic complication in a dialysis patient with acquired cystic disease.

Acquired cystic kidney disease (ACKD) is a complication of end-stage renal disease, the prevalence of which is related to dialysis duration; incidence of ACKD and associated conditions (neoplasia, hemorrhage) have decreased with improvements in renal transplantation and with the ageing of the dialysis population. This report regards spontaneous kidney rupture in a 57-year old patient, on home hemodialysis for 11 years, with ACKD for 5 years. At the end of a dialysis session, the patient reported sudden onset of colicky flank pain, followed by macrohematuria. Pain remitted with low doses of pain relievers, leaving dull flank discomfort. The patient self diagnosed a renal colic, and called the hospital two days later. At referral, two large hemorrhagic renal masses (7 and 2.8 cm) were found at ultrasound and CT scan. At surgery, kidney rupture was diagnosed. This case highlights the life threatening complications associated with ACKD, and underlines that massive renal hemorrhage may occur with relatively minor symptoms.

Renal replacement therapy in intensive care units: a survey of nephrological practice in northwest Italy.

BACKGROUND: Few reports have addressed how current practice reflects uncertainty as to the optimal management of renal replacement therapy (RRT) in Western countries. Current dialytic practice for 2007 in the northwest of Italy was assessed. METHODS: A total of 24 nephrology and dialysis centers covering all of the RRT provided in the intensive care units (ICUs) in northwest Italy took part in the survey. Consultant nephrologists of each center reported their own activities throughout the year 2007 by an e-mailed questionnaire. RESULTS: RRT for a total of 7,842 days was provided by 24 dialysis centers in 79 ICUs for 1,118 patients. RRT median duration (5.76 days/patient) increased with the increasing number of hospital ICU beds. Of the RRT cases, 69.9% were due to acute kidney injury, 23.6% for continuation of a treatment in chronic dialysis patients and 4.2% for extrarenal indications. More than 90% of the patients were treated with high permeability membranes, at a median target dosage of 35.0 ml/kg per hour in continuous (39.4%) or extended modality (6-14 hours, 38.5%). Unfractionated heparin was the most common anticoagulant used (67.5%, median 500 IU/hour). In patients at high risk of bleeding, RRT without or with heparin at low-dose + saline flushes was the most commonly adopted line of treatment, followed by citrate (18% of days of dialysis). The decision to start RRT was made by nephrologists alone or in collaboration with intensivists, whereas dose prescriptions were given by nephrologists alone. CONCLUSIONS: This survey may represent a useful starting point for further research into changes in RRT practice and the adoption of common, shared protocols.

Cholesterol crystal embolism syndrome in dialysis patients: an emerging clinical diagnosis?

BACKGROUND: Cholesterol crystal embolism syndrome (CCE) is an increasing end-stage renal disease cause. Few cases have been described on dialysis, despite the high prevalence of the predisposing factors. METHODS: The diagnostic criteria of the present study were: skin lesions, myalgia, fatigue, fever and acute inflammatory serologic signs, in the presence of severe vasculopathy. The precipitating factors were: anticoagulation, endovascular intervention and ulcerated atherosclerotic plaque. RESULTS: Between October 2003 and September 2005, CCE was diagnosed in 6 dialysis patients (of 200-210 on chronic treatment): 5 males, 1 female, median age 59.5 years (47-70) and end-stage renal disease follow-up 11.5 years (3-25). All had severe vasculopathy, 5 cardiopathy, and 4 were failed graft recipients. The treatment included: peritoneal dialysis, daily dialysis, 'conventional' hemodialysis (2 cases) and hemodiafiltration. The diagnosis was based on the clinical-laboratory picture in 1 patient. In the 5 others clues were present (dicumarol therapy, angioplasty, femoral artery thrombosis, CCE predialysis and ulcerated aortic plaque). The therapeutic approach consisted of corticosteroids (5 cases), statins (4 cases) and prostaglandin analogues (4 cases). CONCLUSION: The differential diagnosis of CCE should also be considered in dialysis patients (necrotic lesions, limb pain and vasculitis-like signs).

Home hemodialysis. Revival of a superior dialysis treatment.

BACKGROUND: Home hemodialysis is usually considered a superior therapy, whose decline is related to demographic, social, psychological and financial factors as well as to competition with renal transplantation and PD. METHODS: A home hemodialysis program was started in November 1998 in the University of Torino, Italy (200-210 patients on dialysis). Its main features are the tailoring of dialysis schedules and the acceptance of patients with comorbidity. Nurses assist home sessions in case of short-term problems, while the training center ensures follow-up for long-term clinical and logistic problems. RESULTS: The program started in November 1998 on a previous one (active from 1970 to 1998; 6 patients on treatment in November 1998). Since then, 25 more patients joined the program. Out of 31 patients followed since November 1998, 4 were grafted, 2 died, and 2 dropped out from training. In June 2001, 15 patients were on home hemodialysis, 8 on training. Dialysis schedules and controls are flexible and tailored; in June 2001, range of dialysis time was 1.20-5 h; sessions: 2-6; 8 patients were on thrice-weekly dialysis, 7 on daily dialysis; all patients reached target EKRc >10 ml/min (median 15, range 11-24 ml/min). CONCLUSION: Tailored, flexible schedules allowed home hemodialysis in over 10% of our patients, confirming that there is still room for this treatment in our setting.

Acute digital gangrene in a long-term dialysis patient -- a diagnostic challenge.

BACKGROUND: Vascular complications are frequent in long-term dialysis patients. The differential diagnosis is complex and includes immunological derangement (underlying disease, uremia), vasculopathic-atheroembolic diseases, calciphylaxis, infections, neoplasm, coagulation disorders, and adverse drug effects. CASE REPORT: We report on a 50-year-old male patient with a long follow-up on renal replacement therapy (20 years), currently on daily hemodialysis. The patient's history of kidney transplantation was complicated by seven acute rejection episodes and by Kaposi sarcoma; comorbidity included HLA-B27 positive ankylosing spondylitis, diffuse vascular disease, recurrent atrial fibrillation, chronic hypotension, HCV positivity. Ten days after the start of warfarin for an atrial fibrillation episode, the patient developed digital necrotising ulcerations, rapidly evolving into partial symmetric digital gangrene at distal phalanxes. The timing and evolution of the lesions and the finding of protein S deficiency were the clues for diagnosing warfarin-induced skin necrosis (WISN); the drug was discontinued and therapy with low-molecular weight heparin, plasma and prostacyclin achieved slow resolution of lesions. CONCLUSIONS: According to a combined MEDLINE and EMBASE search, this is the first report of WISN in a hemodialysis patient: underlining the clinical relevance of this uncommon problem, this case exemplifies the difficult differential diagnosis of acute vascular skin lesions in dialysis

Interaction between gene polymorphisms of nitric oxide synthase and renin-angiotensin system in the progression of membranous glomerulonephritis.

BACKGROUND: The renin-angiotensin system (RAS) and nitric oxide synthase (NOS) play a key role in the progression of primary glomerulonephritis (GN). Although previous studies have examined genetic risk associated with single gene variations, experiments assessing risk conferred by multiple gene variations are still scanty. METHODS: The effect of combination of variant alleles of four genes encoding for three components of the RAS [angiotensin converting enzyme insertion/deletion (ACE I/D), angiotensin II receptor 1 (AT1R 1166A/C), angiotensinogen (AGT M235T)] and for NOS (ecNOS4b/a) on the development and progression of membranous GN (MGN) were evaluated in a longitudinal study comparing 117 patients with serum creatinine (s-Cr) <1.5 mg/dl at renal biopsy and follow-up > or = 5 years (Kaplan-Meier and Cox multivariate analysis). The control group consisted of DNA from 171 organ donors. RESULTS: We found no relationship between single or combined variations of the four gene polymorphisms and development of MGN. Among single gene variations, there were no independent genetic risk factors for the progression of renal disease, after adjustment for age, sex, hypertension, proteinuria, s-Cr, chronicity and activity index. However, double variation coincidences such as the combination of the allele a of ecNOS4b/a and both the allele D of ACE I/D (chi(2) =4.80, P = 0.028; HR = 1.97, 95% CI 0.98-3.96) and the allele T of AGT (M235T) (chi(2) = 5.09, P = 0.024; HR = 2.84, 95% CI 1.39-5.82) exerted an additional effect that was higher than that of the single gene variations. CONCLUSION: This study is the first to demonstrate a role for an interaction between simultaneous variations of genes encoding for NOS and components of RAS in the progression of MGN. Interactions between various polymorphisms may explain conflicting results obtained in previous studies that examined single gene variations, since the effect of a single locus variation may be influenced by the simultaneous presence of other variant alleles in polygenic diseases such as primary GN. However, the small sample sizes and possible multiple interactions limited the interpretation of the current findings, which may represent true biological interaction or simply statistical interactions or spurious results due to the small sample sizes.

Lost to follow-up: the bottleneck of early referral to renal units?

BACKGROUND: Early referral is a major goal in chronic kidney diseases; however, loss to follow-up, potentially limiting its advantages, has never been studied. MATERIAL/METHODS: In order to assess the prevalence and causes of loss to follow-up, a telephone inquiry was performed in a renal outpatient unit, mainly dedicated to early referral of diabetic patients. Patients were considered to be in follow-up if there was at least one check-up in the period February 2001-February 2002, and lost to follow-up if the last check-up had occurred in the previous year. The reasons for loss to follow-up were related to typical clinical-biochemical parameters to define a "drop-out profile". RESULTS: 195 patients were on follow-up: median creatinine 1.4 mg/dL, age 64, 76.9% diabetics. 81 patients were lost to follow-up: creatinine 1.4 mg/dL, age 70, 73.8% diabetics. A telephone number was available in 87.6% of the cases; 25 were not found, 7 had died, 24 were non-compliant, 1 was bed-ridden, 12 had changed care unit, 2 had started dialysis. Renal care was shorter in those lost to follow-up; among the latter, serum creatinine and age were significantly lower in non-compliant patients. A logistic regression model confirmed the significance of lower serum creatinine at last check-up in non-compliant patients (p=0.018). CONCLUSIONS: Loss to follow-up is a problem in nephrology; lack of awareness probably causes the higher drop-out rate at lower creatinine levels. The initial period of care may be crucial for long-term compliance. Further studies are needed to tailor organizational and educational interventions.

Vascular access survival and morbidity on daily dialysis: a comparative analysis of home and limited care haemodialysis.

BACKGROUND: Concerns about vascular access failure may have limited the widespread use of daily haemodialysis (DHD). We assessed the incidence and type of vascular access complications during DHD and other schedules, both at home and on limited care haemodialysis. METHODS: All patients were treated in a limited care and home haemodialysis unit with a stable caregiver team (November 1998-November 2002). Vascular access failure, surgical treatment, angioplasty and declotting were studied alone or in combination by univariate and multivariate models. We analysed the effects of age, sex, comorbidity, previous vascular events, schedule, setting of treatment (home, limited care), dialysis follow-up, vascular access (native vs prosthetic, first vs subsequent) and setting of vascular access creation. 'Intention to treat' and 'per protocol' analyses were performed. RESULTS: In 2160 patient-months (home dialysis: DHD 400 months, non-DHD 655 months; limited care: DHD 208 months; non-DHD 897 months), 57 adverse events occurred (27 failures), in which 30 were at home (nine DHD) and 27 were in limited care (five DHD). The probability of remaining free from adverse events at 6 and 12 months was 89% and 80% on DHD and 79% and 76% on other schedules ('intention to treat'). Univariate analyses revealed a significant difference for the setting of the vascular access creation (lower risk of vascular access complications in our centre) and sex (male sex was protective). Logistic regression and Cox analyses confirmed the role for the setting of the vascular access creation. CONCLUSIONS: Although DHD did not appear as a risk factor for vascular access morbidity or failure at home or in a limited care centre setting, the setting of vascular access creation may influence its success.