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LINEE GUIDA, KDIGO E DIALISI PERITONEALE GIANCARLO MARINANGELI U.O.C. NEFROLOGIA E DIALISI GIULIANOVA.

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Presentation on theme: "LINEE GUIDA, KDIGO E DIALISI PERITONEALE GIANCARLO MARINANGELI U.O.C. NEFROLOGIA E DIALISI GIULIANOVA."— Presentation transcript:

1 LINEE GUIDA, KDIGO E DIALISI PERITONEALE GIANCARLO MARINANGELI U.O.C. NEFROLOGIA E DIALISI GIULIANOVA

2 KDOQI and KDIGO 2003 Targets for treatment 2009 Range of risks NKF- Kidney Disease Outcome Quality Initiative Kidney Disease Improving Global Outcomes

3 Kidney Int 2006; 69: From Renal Osteodystrophy to Chronic Kidney Disease - Mineral Bone Disorder (CKD – MBD)

4 Moe et al. Kidney Int 2006;69: A systemic disorder of bone and mineral metabolism due to CKD manifested by either one or a combination of the following: –Abnormalities of Ca, P, PTH, or vit. D metabolism –Abnormalities in bone turnover, mineralization, volume, linear growth, or strength –Vascular or other soft tissue calcification Chronic Kidney Disease – Mineral Bone Disorder (CKD – MBD)

5 K-DIGO: THE CHALLENGES The definition CKD-MBD was new and not used in published clinical studies. Thus each of the three components had to be addressed separately The complexity of pathogenesis make it difficult to differentiate a consequence of the disease from a consequence of its treatment Differences throughout the world in nutrient intake, availability of medications and clinical practice.

6 KDIGO: Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of CKD-MBD

7 Key Categories in KDIGO Diagnosis/Evaluation Treatment Vascular Calcification

8 KDIGO: Grading of Recommendations Strength of Recommendation Implications Level 1 We recommend … Most patients should receive the recommended course of action. Level 2 We suggest … Different choices will be appropriate for different patients. Grade for Quality of Evidence Quality of Evidence A High B Moderate C Low D Very Low Not Graded KDIGO. Kid Int. 2009; 76 (Suppl 113):S1-S130 The strength of a recommendation is determined not just by the quality of evidence, but also by other, often complex judgments regarding the size of the net medical benefit, values and preferences, and costs.

9 KDIGO: Diagnosis of CKD-MBD Biochemical Abnormalities

10 Diagnosis of CKD-MBD: Biochemical Abnormalities In the initial CKD stage a, the recommendation is to monitor serum levels of: –Phosphorus, Calcium, PTH, Alkaline phosphatase In CKD stages 3-5D b, frequency of monitoring serum calcium, phosphorus, and PTH should be based: –On the presence and magnitude of abnormalities –The rate of progression of CKD In children c, the suggestion is to begin monitoring in CKD stage 2 a (1C); b (not graded); c (2D) KDIGO. Kidney Int. 2009; 76 (Suppl 113):S1-S130

11 Diagnosis of CKD-MBD: Biochemical Abnormalities In patients with CKD stages 3-5D, the suggestions a are to: –Measure 25(OH)D (calcidiol) levels –Repeat testing on the basis of: Baseline values Therapeutic interventions –Correct vitamin D deficiency and insufficiency in accordance to treatment strategies recommended for the general population KDIGO. Kidney Int. 2009; 76 (Suppl 113):S1-S130 a (2C)

12 Diagnosis of CKD-MBD: Biochemical Abnormalities In patients with CKD stages 3-5D, –The recommendation a is that therapeutic decisions should be based on: Trends versus a single laboratory value All available CKD–MBD assessments –The suggestion b is that medical practice should be guided by: The evaluation of individual values of serum calcium and phosphorus together Rather than the Ca x P product a (1C); b (2D) KDIGO. Kidney Int. 2009; 76 (Suppl 113):S1-S130

13 Evaluation of CKD-MBD: Biochemical Abnormalities CKD StageKDIGO 3Every 6–12 months 4Every 3–6 months 5 or DEvery 1–3 months Phosphate and Calcium

14 Evaluation of CKD-MBD: Biochemical Abnormalities CKD StageKDIGO 3Based on baseline level and CKD stage 4Every 6–12 months 5 or DEvery 3–6 months PTH

15 Treatment of CKD-MBD: Phosphorus and Calcium

16 Definition of Normal values Normal means within the above ranges. These are normal ranges for healthy individuals. Phosphorus2.5– 4.5 mg/dl Calcium8.5 – 10 (or 10.5) mg/dl iPTH (varies with the assay used) pg/ml [Centers for Disease Control recommendations]

17 Treatment of CKD-MBD: Phosphorus and Calcium In patients with CKD stages 3-5, the suggestions are to: –Maintain serum P in the normal range a –Maintain serum Ca in the normal range b Phosphate binders are suggested in the treatment of hyperphosphatemia c For choice of phosphate binder, it is reasonable to take into account c : –CKD stage –Presence of other components of CKD-MBD –Concomitant therapies –Side-effect profile a (2C); b (2D); c (not graded) KDIGO. Kidney Int. 2009; 76 (Suppl 113):S1-S130

18 Treatment of CKD-MBD: Phosphorus and Calcium In patients with CKD stages 5D, the suggestion is to: –Lower elevated P levels toward normal range (2C) –Use a dialysate Ca concentration between 1.25 and 1.5 mmol/l (2.5 and 3.0 meq/L) (2D) –Increase dialytic phosphate removal in the treatment of persistent hyperphosphatemia (2C) a (2C); b (2D); c (2C) KDIGO. Kidney Int. 2009; 76 (Suppl 113):S1-S130

19 Treatment of CKD-MBD: Phosphorus and Calcium In patients with CKD stages 3-5D and hyperphosphatemia, the recommendation a is to: –Restrict calcium based phosphate binders in the presence of: Arterial calcification Adynamic bone disease Persistently low serum PTH levels –Restrict the dose of calcium based phosphate binders and/or restrict the dose of calcitriol or vitamin D analog are suggested b, in the presence of: Persistent or recurrent hypercalcemia a (1B); b (2C) KDIGO. Kidney Int. 2009; 76 (Suppl 113):S1-S130

20 51% - 83% 57%16% - 54% Calcification Persistently Low PTH ABDHypercalcemia 1,2,3 2 2,3,4 Patients In Whom it is Recommended Calcium Be Restricted 1 Russo D, et al. Am J Neph 2007;27: Chertow GM, et al. Kidney Int. 2002;62: Block GA, et al. Kidney Int. 2005;68: Qunibi W, et al. AJKD Andress D. Kidney Int. 2008;73: KDIGO. KI 2009; 76 (Suppl 113):S1-S130 Calcium Restriction 5 – 40% CKD 3,4,6 20 – 50 % HD 6 40 – 70% PD 5

21 Phosphate Binding Compounds KDIGO. Kid Int. 2009; 76 (Suppl 113):S1-S130

22 KDOQI / KDIGO - treatment recommendations in 5D: Laboratory values KDOQI Recommend. Grading KDIGO Recommend. Grading iPTH (pg/mL)150 to 300Evidence Suggested range 2 to 9 x ULN 2C Corrected Ca (mg/dL) 8.4 to 9.5Opinion Suggested to maintain in the normal range 2D P (mg/dL)3.5 to 5.5Evidence Suggested to lower toward the normal range 2C CaxP (mg 2 /dL 2 )<55Evidence Not suggested to direct clinical practice N/A KDIGO Clinical Practice Guideline for CKD-MBD. Kidney Int 2009;76 (Suppl 113)

23 PTH Levels

24 Treatment of Abnormal PTH levels in CKD-MBD In patients with CKD stages 3-5 not on dialysis, the optimal PTH level is unknown In patients with levels of intact PTH (iPTH) above the upper normal limit of the assay, the suggestion a is to, first evaluate for: –Hyperphosphatemia –Hypocalcemia –Vitamin D deficiency It is reasonable to correct these abnormalities with any or all of the following b : –Reducing dietary phosphate intake and administering phosphate binders, calcium supplements, and/or native vitamin D The suggestion c is to treat with calcitriol or vitamin D analogs if: –Serum PTH is progressively rising and remains persistently above the upper limit of normal for the assay despite correction of modifiable factors a (2C); b (not graded); c (2C) KDIGO. KI 2009; 76 (Suppl 113):S1-S130

25 Treatment of Abnormal PTH levels in CKD-MBD In patients with CKD stage 5D, the suggestion a is to: –Maintain iPTH levels in the range of approximately two to nine times the upper normal limit for the assay (2C) To lower PTH, when it is elevated or rising, the suggestion a is to use: –Calcitriol –Or vitamin D analogs –Or calcimimetics –Or a combination of calcimimetics and calcitriol or vitamin D analogs In patients with severe hyperparathyroidism who fail to respond to medical/pharmacological therapy parathyreidectomy is suggested (2B) a (2C); b (2B) KDIGO. Kidney Int. 2009; 76 (Suppl 113):S1-S130

26 Treatment of Abnormal PTH Levels In CKD-MBD In patients with hypocalcemia, the suggestion a is to reduce or stop: –calcimimetics depending on severity, concomitant medications, and clinical signs and symptoms (2B) If intact PTH levels fall below two times the upper limit of normal for the assay, the suggestion b is to reduce or stop: Calcitriol Vitamin D analogs And/or calcimimetics a (2B); b (2C) KDIGO. Kidney Int. 2009; 76 (Suppl 113):S1-S130

27 KDOQI / KDIGO - PTH TARGETS KDIGO Clinical Practice Guideline for CKD-MBD. Kidney Int 2009;76 (Suppl 113) CKD Stage Target iPTH (pg/ml) KDOQI Grading Target iPTH (pg/ml) KDIGO Grading OpinionNot known 2C OpinionNot known2C 5 ND EvidenceNot known 2C 5D Evidence2 to 9 x ULN2C

28 KDIGO: Diagnosis of CKD-MBD Vascular Calcification

29 Diagnosis of CKD-MBD: Vascular Calcification In CKD stages 3-5D, the suggestions a indicate that: –It is reasonable to use alternatives to CT-based imaging to detect vascular calcifications, including: Lateral abdominal radiograph Echocardiogram –Patients with known vascular/valvular calcifications can be considered at highest cardiovascular risk –It is reasonable to use this information to guide the management of CKD–MBD a (2C) KDIGO. Kidney Int. 2009; 76 (Suppl 113):S1-S130

30 Diagnosis of CKD-MBD: Vascular Calcification In CKD stages 3-5D, the suggestions a indicate that: –It is reasonable to use alternatives to computed tomography- based imaging to detect the presence or absence of vascular calcification, including: Lateral abdominal radiograph Echocardiogram –Patients with known vascular/valvular calcification can be considered at highest cardiovascular risk –It is reasonable to use this information to guide the management of CKD–MBD KDIGO. Kid Int. 2009; 76 (Suppl 113):S1-S130 a (2C)

31 Calcification prevalence increases as kidney function decreases * Chart represents data across three studies of different CKD populations *Russo D, Corrao S, Miranda I, et al. Progression of coronary artery calcification in predialysis patients. Am J Nephrol. 2007;27: Spiegel DM, Raggi P, Mehta R, et al. Coronary and aortic calcifications in patients new to dialysis. Hemodialysis Int. 2004;8: Chertow GM, Burke SK, Raggi P; for Treat to Goal Working Group. Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int. 2002;62:

32 Prevalence of Coronary Artery Calcification in Non-Dialyzed CKD Patients: Meta-Analysis Based on data from Mehrotra R et al. Kidney Int. 2004;66; ; Russo D et al. Am J Kidney Dis. 2004;44: ; Kramer H et al. J Am Soc Nephrol. 2005;16: ; Quinibi WY et al. Kidney Int. 2005;68: ; Spiegel DM et al. 2004;2004: Mehrotra R. J Renal Nutrition. 2006;16: % 40% 54% 73% 90% 93% 0% 20% 40% 60% 80% 100% Patients (%) Kramer 05Russo 04Spiegel 04Qunibi 05Spiegel 04MehrotraKramer 05 Non-Diabetics Diabetics N GFR Stg 3-5 Stg 2-5 <15 48 <15 47 Stg 3-5

33 CAC=0 CAC CAC400 P = Block GA, Raggi P, Bellasi A, Kooienga L, Spiegel DM. Mortality effect of coronary calcification and phosphate binder choice in incident hemodialysis patients. Kidney Int. 2007;71(5): The degree of calcification in patients new to dialysis has a significant impact on mortality

34 4.1.3 …it is probably wise to mantain flexibility with dialysate Ca concentrations…individualized whenever possible…to meet specific patient requirements. Treatment of CKD-MBD: What about PD? Similar considerations apply to PD, in which…Ca concentrations…tailored to individual patients need. Compared to HD…PD pts are exposed to a given dialysate calcium concentration for longer periods of time. Therefore…bags with Ca as high as 3.5 mEq/l (1.75 mmol/l) are generally avoided to prevent calcium overload and the induction of ABD.

35 4.1.3 Concentrations between 1.25 and 1.50 mmol/l (2.5 and 3.0) mEq/l are recommended. Treatment of CKD-MBD: What about PD? PD related points: - more calcium as phosphate binder? - residual renal function - continous, not intermittent, treatment - new solutions, variable Ca

36 In most cases Calcium balance is slightly positive in CAPD with four exchanges and 1,75 mEq/l Ca… …and slightly negative with Ca 1,25 mEq/l Treatment of CKD-MBD: What about PD? S. Bertoli – 2009 O. Simonsen- KI 2003

37 RIMOZIONE DEL FOSFORO IN DIALISI PERITONEALE - FUNZIONE RENALE RESIDUA - PERMEABILITA PERITONEALE - SCHEMA DIALITICO

38 RIMOZIONE DEL FOSFORO IN DP FUNZIONE RENALE RESIDUA 24 pazienti incidenti in DP – GFR start 59,9 L/sett – 7,1 mesi di follow up Bammens et al, AJKD Litri / settimana / 1,73 mq di BSA CLEARANCE CREATININA CLEARANCE UREA CLEARANCE FOSFORO VISITE

39 RIMOZIONE DEL FOSFORO IN DP FUNZIONE RENALE RESIDUA r =0,94 Analisi cross-sectional su 33 pazienti in DP una misura - un paziente, 17 in CAPD, 24 M CLEARANCE CREATININA = 5,15 ± 2,91 ml/min CLEARANCE UREA = 2,70 ± 1,46 ml/min CLEARANCE FOSFORO = 2,50 ± 1,73 ml/min Neri et al – SIN 2007 r =0,49 y = 0,6421x R 2 = 0,6848

40 RIMOZIONE DEL FOSFORO IN DP PERMEABILITA PERITONEALE D/P Lilaj et al, AJKD pazienti, PET standard ore 0,4 0,5 0,6 0,7 0,8 0,9 0,20,4 0,60,8 D/P creat 4 h D/P fosforo 4 h Gallar et al, Nefrologia pazienti, PET standard

41 D/P creatinina 4 hD/P urea 4 h D/P fosforo 4 h Relazione tra il D/P4h del fosforo e D/P4h di creatinina ed urea. Primo PET (a 4.4±3.0 mesi dallinizio della DP), 57 pazienti. Neri et al, SIN 2007 RIMOZIONE DEL FOSFORO IN DP PERMEABILITA PERITONEALE

42 Il trasporto peritoneale del fosforo è: -simile a quello della creatinina (e < a quello dellurea) -risente molto della permeabilità peritoneale -tanto minore quanto maggiore è lintermittenza del trattamento Leliminazione renale è: - simile a quella dellurea - inferiore a quella della creatinina RIMOZIONE DEL FOSFORO IN DP

43 In Summary … Phosphorus Goal = Normal Calcium Calcification represents the highest risk Detect with x-ray/ultrasound Restrict Calcium in 1.Hypercalcemia 2.Calcification 3.Low PTH 4.ADBD PTH Evaluate PTH in context of hyperP, hypoCa, vitamin D deficiency Marked changes should trigger treatment changes Decrease cinacalcet in event of hypocalcemia KDIGO International Clinical Practice Guidelines Treat the trends: Treat P and Ca to normal, PTH to Goal KDIGO. Kidney Int. 2009; 76 (Suppl 113):S1-S130

44 GRAZIE PER LATTENZIONE

45 K-DIGO (global non-profit foundation) Mission Statement To improve the care and outcomes of kidney disease patients worldwide through promoting coordination, collaboration and integration of initiatives to develop and implement clinical practice guidelines.


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