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Dr. José Ramón Paniagua Sierra

Nuevas Soluciones en DP, Sirven? Prueba en diabéticos con transporte peritoneal alto y promedio alto. Dr. José Ramón Paniagua Sierra Unidad de Investigación Médica en Enfermedades Nefrológicas. UMAE HE CMN S XXI, México, D. F. Background.

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Dr. José Ramón Paniagua Sierra

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  1. Nuevas Soluciones en DP, Sirven?Prueba en diabéticos con transporte peritoneal alto y promedio alto Dr. José Ramón Paniagua Sierra Unidad de Investigación Médica en Enfermedades Nefrológicas. UMAE HE CMN S XXI, México, D. F.

  2. Background • Sodium intake and extracellular fluid volume expansion have been associated with hypertension and cardiovascular mortality in the general population • Extracellular fluid volume expansion is the most frequent cause of hypertension in ESRD patients with or without dialysis treatment. It has been related with other predictors of death like left ventricular hypertrophy • Extracellular fluid volume expansion has also been related with lost of RRF and low grade chronic inflammation

  3. Background • Several clinical conditions and serum markers are now known as predictors of clinical outcomes in ESRD patients. Among them: • Diabetes • Cardiovascular morbidity (LVH, HT, proBNP, TNt) • Malnutrition (SA, TF, LBM, TBW, MAC) • Inflammation (CRP, TNF, IL-6) • Fluid and sodium removal • The variety of predictors suggest a complex network of interactions between them. ECFv expansion may have a significant role

  4. ADEMEX Mortality

  5. IL 6 and mortality

  6. C-reactive protein and mortality

  7. Fluid removal and mortality

  8. pBNP and mortality

  9. Relationship of inflammation, ECFv and DM MALNUTRITION OR WASTING CV DEATH INFLAMMATION CV DISEASE

  10. Relationship of inflammation,ECFv and DM MALNUTRITION OR WASTING CV DEATH INFLAMMATION CV DISEASE PRESSURE  VOLUME PERITONEAL PERMEABILITY ECFv EXPANSION

  11. Relationship of inflammation, ECFv and DM MALNUTRITION OR WASTING  CV DEATH  INFLAMMATION CV DISEASE   PRESSURE  VOLUME PERITONEAL PERMEABILITY  ?  ECFv EXPANSION  D M CHO-PTG

  12. Background • The success in the control of ECFv of PD patients depends on: • Sodium and fluid intake • Residual renal function • Peritoneal transport type (PET) • Type and concentration of the osmotic agent in the dialysis solution

  13. Background • Glucose is the most commonly used osmotic agent. Disadvantages: • Damage of mesothelial cells by glucose degradation products and advanced glycation products • Peritoneal glucose absorption. Then: • Loss of osmotic gradient = deficientUF • Obesity, low protein intake, impairment in metabolic control • Diabetes increases glucose disadvantages

  14. It has been successfully used as osmotic agent, particularly in high transporters It does not have the glucose disadvantages Icodextrin Chain α (1→6) Chain α (1→4)

  15. Background • In spite of the potential benefits of icodextrin in increasing ultrafiltration without metabolic disadvantages in high-transport diabetic PD patients, RCT are not available • Information is important for populations with high rates of diabetics in their PD programs. This is the case of Mexico and other countries.

  16. Primary outcomes: Improvement in peritoneal UF Reduction of ECFv Control of BP, edema and CV function Metabolic control Secondary outcomes: Nutrition improvement Control of inflammation Quality of life Mortality Objective To test the clinical usefulness of icodextrin based solution in high transport diabetic patients in PD

  17. Study designTarget of treatment • To reach control of blood pressure and edema through the increment in peritoneal ultrafiltration • Treatments. 3x2L, 1.5% glucose exchanges plus: • Control group: Glucose-based solutions, at least 1 bag with 2.5% glucose in the longest dwell • Icodextrin group: Icodextrin-based solution (7.5%) in the longest dwell • Replacement of 1.5% for 2.5 or 4.25% glucose was allowed to reach the treatment goal

  18. Study design • Randomized clinical trial • Open label • Multicentric (HGZ 8; HGZ 25; HGZ 27; HGZ 47. IMSS, México, D. F.) • Central randomization • Central laboratory (UIMEN) • Follow-up: 6 months; 12 months

  19. Inclusion criteria Diabetics Adults High and high average transport Without selection by gender or time on dialysis No inclusion criteria Seropositivity HB, HIV CA, immunosuppression Exclusion criteria Patient decision Medical decision Transplant Change of address Material and methodsPatients

  20. Results • Without differences between groups at baseline in: • Age • Gender • Blood pressure • Body composition • Dialysis adequacy • Biochemical parameters • Comorbidity

  21. Results • Prescription • In the control group two thirds of the patients needed more than one bag of 2.5% glucose or at least one bag of 4.25% glucose. In the icodextrin group only 9% needed a bag with more than 1.5% of glucose

  22. ResultsActual prescription

  23. Results Metabolic control

  24. Results

  25. Results

  26. Results Mean±EEM *p<0.05; ** p<0.03; *** p<0.01 vs Control ‡p<0.05; ‡ ‡ p<0.03; ‡ ‡ ‡ p<0.01 vs Basal

  27. Results

  28. Results

  29. Results

  30. Results

  31. Results

  32. Results Body fluids and cardiovascular parameters

  33. ResultsUltrafiltration

  34. Results

  35. ResultsBP (in office)

  36. * * * * * ** * ** ** ** ** ** *= p<0.05 vs basal; **= p<0.01 vs basal; = p<0.05 vs glucose group;  = p<0.01 vs glucose group ResultsBP (ambulatory)

  37. ResultsEKG basal

  38. ResultsEKG changes

  39. ResultsIcodextrin metabolites

  40. ResultsIcodextrin metabolites

  41. Results Mortality ( ) = number of patients. *= Death related to dropout cause. [ ] Dialysis modality at the time of death Death was considered related to dropout case if occurred in the 30 days after dropout and the final diagnosis was related to the technique failure

  42. Results Mortality

  43. Results Mortality

  44. Results Annual Cost of Patient on Dialysis $300 x1000 $250 $200 $150 $100 $50 $- APD CAPD CAPD DP HD INST HD SUB Icodextrin Consumables Pharmacologic t Laboratory Hospitalization Peritonitis Catheter dysfunction Disability Emergency Personal Infrastructure Transport

  45. Relationship of inflammation, ECFv and DM MALNUTRITION OR WASTING X  CV DEATH x INFLAMMATION CV DISEASE X  x PRESSURE  VOLUME PERITONEAL PERMEABILITY  ? X  ECFv EXPANSION X  D M CHO-PTG ICODEXTRIN

  46. Conclusion • Patients in the Icodextrin group had better metabolic control and nutrition • Icodextrin-based solution was superior to glucose-based solution in fluid and sodium removal. • Patients in the Icodextrin group had better control of blood pressure and reduction in left ventricular mass

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