Diálisis y Trasplante - PDF

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Documento descargado de el 6//7. Copia para uso personal, se prohíbe la transmisión de este documento por cualquier medio o formato. Dial Traspl. ;(4): -4 Diálisis y Trasplante

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Documento descargado de el 6//7. Copia para uso personal, se prohíbe la transmisión de este documento por cualquier medio o formato. Dial Traspl. ;(4): -4 Diálisis y Trasplante ORIGINAL ARTICLE Practice pattern of chronic kidney disease-mineral and bone disorder (CKD-MBD) in hemodialysis patients in a tertiary care centre in India Malleshappa Pavan a,, Ravi Ranganath b, Anup P. Chaudhari b, Keerti L. Upadhayaya c, Hemant J. Mehta c a Vaatsalya Hospital, Bharathi Healthcare Complex, R C Road, Hassan, Karnataka, India b Department of Nephrology, Lilavati Hospital and Research Centre, Mumbai, India c Lilavati Hospital and Research Centre, Mumbai, India Received October ; accepted 5 December Available online 4 June KEYWORDS CKD-MBD; Hemodialysis; Bone health; Mortality Abstract Objective: To determine the prevalence of chronic kidney disease mineral bone disorder (CKD-MBD) and its association with morbidity and mortality among hemodialysis patients. Design: Observational study. Patients: patients on maintenance hemodialysis were studied over months at the Lilavati Hospital and Research Centre, Mumbai, India. Results: Serum calcium and serum phosphorus levels were monitored as per the recommended guidelines in only 8% of patients. Serum parathyroid hormone (PTH) levels were monitored in only % of patients. Majority of patients had high PTH values ( pg/ml). Patients with low PTH ( 5 pg/ml) had a higher mortality and morbidity as compared to those with normal and high PTH. Conclusion: This study shows that calcium/phosphorus/pth monitoring is not done as per recommendations even in a tertiary care centre in India. The small magnitude of the associations observed in this study should serve to highlight the need to pursue other means of improving bone health among hemodialysis patients. SEDYT. Published by Elsevier España, S.L. All rights reserved. Corresponding author. address: dr (M. Pavan) /$ see front matter SEDYT. Published by Elsevier España, S.L. All rights reserved. doi:.6/j.dialis... Documento descargado de el 6//7. Copia para uso personal, se prohíbe la transmisión de este documento por cualquier medio o formato. Practice pattern of CKD-MBD in hemodialysis patients PALABRAS CLAVE CKD-MBD; Hemodiálisis; Salud ósea; Mortalidad Estrategia de práctica clínica de las alteraciones del metabolismo óseo en la enfermedad renal crónica (CKD-MBD) en pacientes sometidos a hemodiálisis en un centro de asistencia terciaria de la India Resumen Objetivo: Determinar la prevalencia de las alteraciones del metabolismo óseo en la enfermedad renal crónica (CKD-MBD) y su asociación con la morbilidad y la mortalidad entre pacientes sometidos a hemodiálisis. Diseño: Estudio observacional. Pacientes: En el Lilavati Hospital and Research Centre, Mumbai, la India, durante meses, se estudió a pacientes sometidos a hemodiálisis de mantenimiento. Resultados: Tan sólo en el 8% de pacientes se supervisaron los valores séricos de calcio y fósforo según las guías recomendadas. Los de parathormona (PTH) sólo se supervisaron en el % de pacientes y en la mayoría se detectaron valores altos ( pg/ml). En pacientes con valores bajos ( 5 pg/ml) se evidenció una mayor mortalidad y morbilidad, comparado con aquéllos con valores normales y altos de la hormona. Conclusión: El presente estudio revela que, en la India, ni siquiera en un centro de asistencia terciaria se implementa la supervisión de los valores séricos de calcio/fósforo/pth según lo recomendado por las guías. La pequeña magnitud de las asociaciones observadas en el presente estudio debería servir para destacar la necesidad de aplicar otros medios de mejorar la salud ósea entre pacientes sometidos a hemodiálisis. SEDYT. Publicado por Elsevier España, S.L. Todos los derechos reservados. Introduction Materials and methods Chronic kidney disease-mineral and bone disorder (CKD-MBD) is a systemic syndrome involving abnormalities in serum phosphorus, calcium and parathyroid hormone (PTH) concentrations, together with abnormalities in vitamin D metabolism and bone turnover. Abnormalities in serum phosphorus, calcium and PTH levels, common among patients with chronic kidney disease, have been associated with increased cardiovascular calcification, -4 arterial dysfunction, 5,6 morbidity and mortality. 7,8 Recent studies have shown thatlevels of serum phosphorus, calcium and PTH outside clinical guidelines 9 - are associated with increased mortality and cause-specific hospitalization among hemodialysis patients. Our study presents the levels of CKD-MBD markers as well as their associations with clinical and mortality outcomes in patients undergoing maintenance hemodialysis (MHD). Aim To evaluate chronic hemodialysis population in a tertiary care hospital based dialysis unit for: () Frequency of biochemical assessment of MBD on MHD. () What is the pattern of renal bone disease in our hemodialysis population? () Outcome with respect to complications and survival. (4) Are we following recommended guidelines, and achieving recommended goals? This is an observational study conducted at the Lilavati Hospital and Research Centre, Mumbai, India from //9 to //9. patients undergoing maintenance hemodialysis were observed over months. Frequency of assessment of serum calcium, phosphorous, PTH and vitamin D were noted, including baseline values if available. Prescription patterns were analyzed, to note down if any changes were made after reports. All events on dialysis and at home were noted. Statistical analysis The mean and standard deviation are reported for continuous variables and number and percentage are reported for categorical variables. Chi-square test was used to compare variables and p value of .5 was significant. Results Hundred patients who are on maintenance hemodialysis (MHD) were included in this study. Mean age of the patients studied are 5.9 ± years. Mean duration on MHD is 6 months (Table ). Majority of patients (7%) are undergoing thrice a week MHD (Fig. ). Only patients out of got their serum parathyroid hormone (PTH) levels checked every -6 months, in last one year period and 7 out of patients got their vitamin D levels (Fig. ) and their values are shown in Table. At baseline, before entry into our Documento descargado de el 6//7. Copia para uso personal, se prohíbe la transmisión de este documento por cualquier medio o formato. M. Pavan et al. Table Patient characteristics. 5 Age Sex Male 5 Female 49 Etiology DM Others 5.9 ± years 56 a 44 b Mean duration on MHD 6 months [6-9 months] Phosphate binders Calcium carbonate 4 Calcium acetate 56 Sevelamer 6 Lanthanum 5 Sevelamer + lanthanum 4 Sevelamer + lanthanum + nicotinic acid Sevelamer + nicotinic acid a DM: diabetes mellitus. b Others: hypertensive nephrosclerosis, chronic glomerulonephritis, chronic interstitial nephritis. 8 Frequency of hemodialysis/week 4 Figure PTH 7 Vitamin-D Serum PTH and vitamin D test done in last year. Table Serum calcium, serum phosphorus and calcium phosphorus product. Serum 8.5 mg/dl 8.5 mg/dl calcium 8 9 Serum 5.5 mg/dl 5.5 mg/dl phosphorous Calcium phosphorous product 55 / Week / Week 4/ Week Figure Frequency of hemodialysis per week. 5 HD program, 5% patients did not have serum calcium and phosphorus estimation in last months and baseline PTH and vitamin D levels were not done in 9% of patients. Serum calcium and phosphorus levels were monitored every - months in 8% of patients only, where as most patients (74%) did it once in months in spite of advise to do it monthly. Mean values of serum calcium is 9.4 ±.9 mg/dl and serum phosphorus is 5.59 ±.8 mg/dl and 9% had elevated calcium-phosphorus product (Table ). Majority of patients in whom serum PTH values were measured ( out of ) had higher PTH values ( pg/ml) (Fig. ). 5 adverse events including 7 deaths were noted during this one year period (Table 4). Patients with low PTH had a higher mortality and morbidity as compared to those with high PTH (Figs. 4-6). 5 4 (5-) Figure High ( ) Serum PTH distribution. 7 Low ( 5) Table Serum PTH and vitamin D test results. Serum PTH (n = ) Serum vitamin D (n =7) (5 - pg/ml) High ( pg/ml) Low PTH ( 5 pg/ml) 4 7 LOW ( 6 ng/ml) (6-7 ng/ml) 5 Documento descargado de el 6//7. Copia para uso personal, se prohíbe la transmisión de este documento por cualquier medio o formato. Practice pattern of CKD-MBD in hemodialysis patients Table 4 Adverse events in last one year. Death (7) Cerebro vascular accidents 7 (4) a Acute coronary syndrome () AV fistula thrombosis 7 Fracture (long bones and spine) 6 () Acute pancreatitis () Priapism Severe pruritis Parathyroid adenoma Amputation Recurrent dislocation a Combined CVA and ACS. Discussion KDIGO (Kidney Disease: Improving Global Outcomes) is an international initiative with a key mission of developing clinical practice guidelines in the area of chronic kidney disease (CKD). KDIGO recently published an evidence-based clinical practice guideline for the prevention, diagnosis, evaluation, and treatment of metabolic bone disease in individuals with CKD. 4 KDIGO proposed a definition for CKD-mineral and bone disorder (CKD-MBD) and for renal osteodystrophy. 5 The KDIGO guideline addresses the evaluation and treatment of abnormalities of CKD-MBD in adults and children with CKD stages -5 on long-term dialysis therapy or with a kidney transplant. Tests considered are those that relate to laboratory, bone, and cardiovascular abnormality detection and monitoring. 5 Figure 5 group. CVA Amputation No events Adverse events in normal PTH (5 - pg/dl) KDIGO recommend monitoring serum levels of calcium, phosphorus, PTH, and alkaline phosphatase activity beginning in CKD stage. Guidelines also suggest that it is reasonable to base the frequency of monitoring serum calcium, phosphorus, and PTH on the presence and magnitude of abnormalities, and the rate of progression of CKD. Reasonable monitoring intervals In CKD stage 5, including 5D would be: for serum calcium and phosphorus, every - months; and for PTH, every -6 months. 4 They also suggest that in patients with CKD stage 5D, 5(OH)D (calcidiol) levels might be measured, and repeated testing determined by baseline values and therapeutic interventions. In our study only 8% of patients adhered to the KDIGO guidelines and got their serum calcium and phosphorus values checked every Death Fracture ACS CVA Death Parathyroid adenoma Fracture ACS AVF thrombosis CVA Figure 4 Adverse events in low PTH ( 5 pg/ml) group. Figure 6 Adverse events in high PTH ( pg/dl) group. Documento descargado de el 6//7. Copia para uso personal, se prohíbe la transmisión de este documento por cualquier medio o formato. 4 M. Pavan et al. months. Only % of patients got their serum PTH checked as per KDIGO and only 7% got their 5(OH)D levels checked during our study period. This could be attributed to high renal replacement therapy (RRT) costs in India. India has no governmental reimbursement for dialysis, and only a small percentage of patients with ESRD have employer sponsors or health insurance that pays for RRT. In the Dialysis Outcomes and Practice Patterns Study (DOPPS) the distribution of PTH levels was wide and markedly skewed. 6 Large differences in PTH distributions were observed across phases and countries, especially in Italy, the United Kingdom, and Australia and New Zealand. No significant trend was seen in mean PTH levels in the overall DOPPS population. Our study showed that majority of patients ( out of ) had increased PTH values. Distributions of baseline serum calcium and phosphorus levels in DOPPS study was 9. ±.9 mg/dl and 5.5 ±.8 mg/dl, respectively. 6 Mean values of serum calcium and phosphorus in our study was 9.4 ±. mg/dl and 5.59 ±.7 mg/dl. DOPPS study showed that PTH levels of pg/ml or less were associated with significantly greater cardiovascular mortality only in time-dependent models. 6 Significantly greater all cause mortality risk was observed for PTH levels greater than 6 pg/ml (ng/l). In contrast to these findings as well as findings from previous studies, our study showed patients with low PTH had a higher mortality and morbidity as compared to those with high PTH. Our study showed that patients with low PTH had greater cardiovascular mortality, consistent with DOPPS study results. This is an observational study; our findings can indicate associations, but not causal relationships, between mineral metabolism indicators and mortality. Bone biopsy was not done in our study population, we are defining the type of bone disease based on PTH levels. The study period was too less and we acknowledge that calcium, phosphorus, and PTH have not been validated as surrogate markers for such hard end points as mortality. Conclusion Guidelines for CKD-MBD are clear about monitoring of bone health in dialysis patients, however even in a tertiary care centre, with majority patients taking thrice a week HD, calcium/phosphorus/pth monitoring is not done as per recommendations. It is possible that interventional studies will show a link between calcium, phosphorus, PTH and morbidity and mortality among hemodialysis patients and that appropriate treatment of these derangements according to current practice guidelines will result in improved bone health and quality of life. Conflict of interest The authors declare no conflict of interest. References. Moe S, Drüeke T, Cunningham J, Goodman W, Martin K, Olgaard K, et al. Definition, evaluation, and classification of renal osteodystrophy: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 6;69: Qunibi WY, Nolan CA, Ayus JC. Cardiovascular calcification in patients with end-stage renal disease: a century-old phenomenon. Kidney Int. ;6 Suppl 8:S7-8.. Goodman WG, Goldin J, Kuizon BD, Yoon C, Gales B, Sider FD, et al. Coronary-artery calcification in young adults with endstage renal disease who are undergoing dialysis. N Engl J Med. ;4: Kestenbaum B, Sampson JN, Rudser KD, Patterson DJ, Seliger SL, Young B, et al. Serum phosphate levels and mortality risk among people with chronic kidney disease. J Am Soc Nephrol. 5;6: Krasniak A, Drozdz M, Pasowicz M, Chmiel G, Michalek M, Szumilak D, et al. Factors involved in vascular calcification and atherosclerosis in maintenance haemodialysis patients. Nephrol Dial Transplant. 7;: London GM, Guerin AP, Verbeke FH, Pannier B, Boutouyrie P, Marchais SJ, et al. Mineral metabolism and arterial functions in end-stage renal disease: potential role of 5-hydroxyvitamin D deficiency. J Am Soc Nephrol. 7;8: Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM, et al. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 4;5: Melamed ML, Eustace JA, Plantinga L, Jaar BG, Fink NE, Coresh J, et al. Changes in serum calcium, phosphate, and PTH and the risk of death in incident dialysis patients: a longitudinal study. Kidney Int. 6;7: Stevens LA, Djurdjev O, Cardew S, Cameron EC, Levin A. Calcium, phosphate, and parathyroid hormone levels in combination and as a function of dialysis duration predict mortality: evidence for the complexity of the association between mineral metabolism and outcomes. J Am Soc Nephrol. 4;5: Young EW, Akiba T, Albert JM, McCarthy JT, Kerr PG, Mendelssohn DC, et al. Magnitude and impact of abnormal mineral metabolism in hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study. Am J Kidney Dis. 4;44 Suppl :S4-8.. Young EW, Albert JM, Satayathum S, Goodkin DA, Pisoni RL, Akiba T, et al. Predictors and consequences of altered mineral metabolism: the Dialysis Outcomes and Practice Patterns Study. Kidney Int. 4;67: Noordzij M, Korevaar JC, Boeschoten EW, Dekker FW, Bos WJ, Krediet RT, et al. The Kidney Disease Outcomes Quality Initiative (K/DOQI) guideline for bone metabolism and disease in CKD: association with mortality in dialysis patients. Am J Kidney Dis. 5;46: Tentori F, Hunt WC, Rohrscheib M, Zhu M, Stidley CA, Servilla K, et al. Which targets in clinical practice guidelines are associated with improved survival in a large dialysis organization? J Am Soc Nephrol. 7;8: Kidney Disease: Improving Global Outcomes (KDIGO), CKD-MBD, Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl. 9;:S Moe S, Drueke T, Cunningham J, Goodman W, Martin K, Olgaard K, et al. Definition, evaluation, and classification of renal osteodystrophy: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 6;69: Tentori F, Blayney MJ, Albert JM, Gillespie BW, Kerr PG, Bommer J. Mortality risk for dialysis patients with different levels of serum calcium, phosphorus, and PTH: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Am J Kidney Dis. 8;5:59 -.
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