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Proteina c activada en el paciente quirúrgico

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Proteina c activada en el paciente quirúrgico

  1. 1. Proteina C activada en el paciente quirúrgico Anestesia y Reanimación Hospital Universitario La Princesa
  2. 2. 100 años de un cambio fundamental
  3. 3. De la cirugía a la sepsis : un continium
  4. 4. SRIS y Cirugía
  5. 5. Sepsis y Cirugía : cuales están más cercanos
  6. 6. Sepsis y fallo multiorganico : ¿os suena ?
  7. 7. Sepsis y coagulación
  8. 8. Proteina C activada efectos fisiologicos beneficiosos en peritonitis
  9. 9. Después de la observación , entran las dudas …y el viaje continúa
  10. 10. INDEPHT
  11. 11. INDEPHT 2
  12. 12. INDEPHT 3
  13. 13. INDEPHT 4
  14. 14. INDEPHT 5
  15. 15. INDEPHT 6
  16. 16. INDEPHT 7
  17. 17. INDEPHT 8
  18. 18. INDEPHT 9
  19. 19. Los piratas y el mentiroso
  20. 20. Xigris Inglaterra
  21. 21. Xigris Inglaterra
  22. 24. Una buena manera de pensar
  23. 25. Pacientes quirúrgicos en el Prowess : podemos saber más … Barie PS, et al. Am J Surg 2004; 188:212-220. Surgical N=474 Non-Surgical N=1216 p-Value Gender Male, n(%) 261 (55.1) 703 (57.8) Female, n(%) 213 (44.9) 513 (42.2) Age (years) Mean, SE 62.5 + 0.7 59.8 + 0.5 Median 66.2 62.3 0.002 APACHE II (Mean + SE) 23.5 + 0.36 25.3 + 0.22 0.001 Organ Dysfunctions (Mean + SE) 2.6 + 0.05 2.3 + 0.03 0.001
  24. 26. Fallos orgánicos pacientes quirúrgicos del PROWESS Barie PS, et al. Am J Surg 2004; 188:212-220. Barie PS, et al. Crit Care Med 2003; 30(S12 ):A102. Surgical (N=474) Non-Surgical (n=1216) Total p-Value Shock, n (%) Yes 347 (73.2) 853 (70.1) 1200 NS No 127 (26.8) 363 (29.9) 490 Vasopressors, n (%) Yes 315 (66.5) 742 (61.0) 1057 NS No 159 (33.5) 474 (39.0) 633 Ventilation, n (%) Yes 432 (91.1) 843 (69.3) 1275 0.001 No 42 (8.9) 373 (30.73) 415
  25. 27. Biomarcadores pacientes quirúrgicos del PROWESS Data on File, Lilly Research Laboratories, F1KNOV2005M. Barie PS, et al. Am J Surg 2004; 188:212-220. Surgical (N=474) Non-Surgical (n=1216) p-Value D-dimer (NL=0-0.39 mcg/ml) N=443 N=1107 <0.001 Median (IQR) 5.4 (3.1-9.3) 3.8 (1.9-7.7) IL-6 (NL=0.38-10.1 pg/ml) N=463 N=1172 <0.001 Median (IQR) 600 (228-2544) 418 (188-2589) Protein C Activity (NL= 81-173%) N=449 N=1125 <0.001 Median (IQR) 41 (27-59) 50 (34-69)
  26. 28. Edad y APACHE II en los quirúrgicos del PROWESS Barie PS, et al. Am J Surg 2004; 188:212-220. Surgical N=474 Non-Surgical N=1216 p-Value APACHE II Mean, SEM 23.5 + 0.36 25.3 + 0.22 <0.001 Acute Physiological Mean, SEM 19.1 + 0.33 20.8 + 0.22 <0.001 Chronic Health Mean, SEM 0.6 + 0.07 1.1 + 0.06 <0.001 Age (years) Mean, SEM 3.7 + 0.10 3.3 + 0.06 <0.002
  27. 29. Cirugía inicial en los pacientes quirúrgicos del PROWESS * Miscellaneous includes orthopedic, obstetrical, head and neck, neurological, and percutaneous device placement Barie PS, et al. Am J Surg 2004; 188:212-220. Surgical Category Placebo Drotrecogin alfa (activated) Total N=246 N=228 N=474 Intra-abdominal, n (%) 157 (63.8) 158 (69.3) 315 (66.5) Thoracic, n (%) 15 (6.1) 12 (5.3) 27 (5.7) Vascular, n (%) 13 (5.3) 13 (5.7) 26 (5.5) Skin, n (%) 11 (4.5) 13 (5.7) 24 (5.1) Cardiac, n (%) 12 (4.9) 5 (2.2) 17 (3.6) Genitourinary, n (%) 6 (2.4) 8 (3.5) 14 (2.9) Trauma, n (%) 7 (2.8) 3 (1.3) 10 (2.1) Miscellaneous * , n (%) 25 (10.2) 16 (7.0) 41 (8.6)
  28. 30. Infección pre o post cirugía Barie PS, et al. Am J Surg 2004; 188:212-220. Placebo N=246 Drotrecogin alfa (activated) N=228 Total N=474 Infection Present Prior to Surgery, n (%) Pre-op Severe Sepsis 121 (49.2) 129 (56.6) 250 (52.7) Surgery Prior to Infection, n (%) Post-op Severe Sepsis 125 (50.8) 99 (43.4) 224 (47.3)
  29. 31. Fuente primaria de infección * Miscellaneous includes central nervous system, head and neck, cardiac, pleural, bone, gynecologic, skin, other, and unknown Barie PS, et al. Am J Surg 2004; 188:212-220. Surgical N=468 Non-Surgical N=1171 p-Value Lung, n (%) 95 (20.3) 790 (67.5) <0.001 Intra-abdominal, n (%) 295 (63.0) 68 (5.8) <0.001 Urinary, n (%) 23 (4.9) 179 (15.3) <0.001 Miscellaneous * , n (%) 83 (17.7) 160 (13.7) 0.036
  30. 32. Tipo de infección según el GRAM Note: Type of infection determined by the PROWESS Clinical Evaluation Committee Barie PS, et al. Am J Surg 2004; 188:212-220. Surgical N=474 Non-Surgical N=1216 Pure Gram +, n (%) 72 (15.2) 354 (29.1) Pure Gram -, n (%) 105 (22.1) 297 (24.4) Mixed Gram, n (%) And other organisms 109 (23.0) 110 (9.1) Fungal, n (%) 38 (8.0) 24 (2.0) Unknown/none, n (%) 150 (31.6) 431 (35.4)
  31. 33. Estado de la coagulación el los pacientes quirúrgicos del PROWESS Data on File, Lilly Research Laboratories, F1KNOV2005O. Barie PS, et al. Am J Surg 2004; 188:212-220. Surgical N=474 Non-Surgical N=1216 p-Value aPTT (sec) n=446 n=1115 <0.001 Median (IQR) 44.6 (38.3 – 52.2) 41.9 (35.5 – 49.6) PT (sec) n=446 n=1112 <0.001 Median (IQR) 20.1 (17.5 – 23.9) 18.1 (16.2 – 21.3) Platelets (10 3 /mm 3 ) n=407 n=1012 NS Median (IQR) 188 (124-272) 180 (114-242)
  32. 34. Mortalidad subgrupos quirúrgicos en el PROWESS Mortality Rate Other Surg 159 32.6% 42.0% -10.3 0.5 0.6 0.7 0.8 1 1.25 1.67 2 0.9 Relative Risk of Death (Point Estimate and 95% CI) PROWESS Overall Surgical Cohort 1690 30.8% 24.7% 6.1 474 31.3% 28.1% 3.2 N Placebo DrotAA Non-Surgical Cohort 1216 30.6% 23.5% 7.1 Data on File, Lilly Research Laboratories, F1KNOV2005P. Barie P, et al. Crit Care Med 2003; 30(S12):A102. Barie PS, et al. Am J Surg 2004; 188:212-220. Intra-abd 315 30.6% 21.5% 9.1 Absolute Risk Reduction
  33. 35. PROWESS: Subgroup Mortality 0.5 0.6 0.7 0.8 1 1.25 1.67 2 0.9 Relative Risk of Death (Point Estimate and 95% CI) PROWESS Overall 1690 30.8% 24.7% 6.1 APACHE II < 25 278 20.0% 22.5% -2.5 APACHE II  25 196 46.2% 36.7% 9.5 Surgical Cohort 474 31.3% 28.1% 3.2 Organ Dysf <2 94 19.6% 22.9% -3.3 Organ Dysf  2 380 34.0% 29.4% 4.6 N Placebo DrotAA Mortality Rate Data on File, Lilly Research Laboratories, F1KNOV2005Q. Barie PS, et al. Am J Surg 2004; 188:212-220. Absolute Risk Reduction
  34. 36. PROWESS: Treatment Emergent Bleeding Events by Treatment and Surgical Status (SEC) During Infusion (n=19) (n=38) (n=49) (n=39) (n=122) (n=72) (n=163) (n=110) (n=228) (n=246) (n=228) (n=246) (n=622) (n=594) (n=622) (n=594) During Infusion 28-Day 28-Day Surgical Patients Non - Surgical Patients p=0.0028 p=0.0004 p=0.0013 p-value from Pearson’s chi square Percent of Patients Data on File, Lilly Research Laboratories, F1KNOV2005R. Barie PS, et al. Am J Surg 2004; 188:212-220.
  35. 37. PROWESS: Serious Adverse Bleeding Events (SEC) (n=8) (n=20) (n=7) (n=0) (n=8) (n=13) (n=17) (n=30) (n=4) (n=8) (n=13) (n=22) (n=840) (n=850) (n=246) (n=228) (n=594) (n=622) (n=840) (n=850) (n=246) (n=228) (n=594) (n=622) All Prowess Surgical Non-Surgical All Prowess Surgical Non-Surgical Drug Infusion Period 28 Day Study Period p=0.024 p=0.006 p=0.060 Percent of Patients Percent of Patients Data on File, Lilly Research Laboratories, F1KNOV2005S. Barie PS, et al. Am J Surg 2004; 188:212-220.
  36. 38. PROWESS: Transfusions Received * (SEC) Percent of Patients (n=93) (n=86) (n=69) (n=114) (n=33) (n=38) (n=63) (n=76) (n=187) (n=191) (n=303) (n=342) (n=246) (n=228) (n=594) (n=622) (n=246) (n=228) (n=594) (n=622) (n=246) (n=228) (n=594) (n=622) Surgical Non-Surgical Surgical Non-Surgical Surgical Non-Surgical p=0.0358 p=0.0011 <ul><li>FFP= Fresh Frozen Plasma; PLTS = Platlets; PRBRC = Packed Red Blood Cells </li></ul>* Data not adjusted to account for differences in survivor numbers Data on File, Lilly Research Laboratories, F1KNOV2005T. FFP PLTS PRBCs
  37. 40. Llega la hora de enfrentarse a la realidad
  38. 41. Vale pero tengo dudas …
  39. 42. 1º ¿A qué pacientes se la pongo ? <ul><li>debo usar el APACHE II ? </li></ul><ul><li>debo medir el dímero D ? </li></ul><ul><li>Yo no se la pongo si antes no mido la proteina C ¡¡¡ </li></ul>
  40. 43. 2º Evolución dímero D
  41. 44. 3º Niveles proteina C
  42. 45. Niveles proteina C
  43. 46. 4º Precauciones en el uso de la Proteina C activada
  44. 47. 5º Situaciones que requieren especial precaución , cuando se administre Drotrecogin alfa (activada) . <ul><li>Heparina a más de 15 U/Kgr por hora </li></ul><ul><li>INR > 3 </li></ul><ul><li>Sangrado gastrointestinal en las últimas 6 semanas </li></ul><ul><li>Administración de fibrinolíticos en los últimos 3 días . </li></ul><ul><li>Administración de anticoagulantes orales o de inhibidores de la glicoproteina IIb/IIIa en los últimos 7 días . </li></ul><ul><li>Administración de aspirina en dosis superior a 650 mgr/día o de otro antiagregante plaquetario en los últimos 7 días . </li></ul><ul><li>Accidente cerebro-vascular isquémico en los últimos 3 meses </li></ul><ul><li>Malformación arterio-venosa intracraneal </li></ul><ul><li>Diatesis hemorrágica conocida. </li></ul><ul><li>Enfermedad hepática crónica severa ( Child grado C ) . </li></ul><ul><li>Cualquier patología asociada o situación clínica que este asociada a un riesgo de sangrado severo o vital . </li></ul>
  45. 48. 6. Contraindicaciones para la administración de Drotrecogin alfa . <ul><li>Sangrado interno activo </li></ul><ul><li>Accidente cerebrovascular hemorrágico en los últimos tres meses </li></ul><ul><li>Traumatismo craneoencefálico severo , cirugía intracraneal o intraespinal en los últimos dos meses . </li></ul><ul><li>Trauma con alto riesgo de sangrado vital ( ej: hígado , bazo , fracturas pélvicas complicadas ) </li></ul><ul><li>Pacientes portadores de cateter epidural o cuya colocación se haya producido en las últimas 12 horas . </li></ul><ul><li>Pacientes con tumor intracraneal , o evidencia de herniación cerebral </li></ul><ul><li>Plaquetas < 30.000 incluso si se pasa de esa cifra con transfusiones. </li></ul>
  46. 49. … pero aún tengo más dudas ¡¡¡ <ul><li>Cuando debo comenzar el tratamiento ? </li></ul><ul><li>Qué criterio hay para saber cual es el momento adecuado ‘ </li></ul><ul><li>No es paradójico esperar a que el paciente confirme su gravedad o aumente el número de fallos ? </li></ul>
  47. 50. Ummmm pero no lo tengo claro <ul><li>Existe una ventana temporal ? </li></ul><ul><li>Cuanto tiempo se puede esperar esperar desde el establecimiento del dco ? </li></ul><ul><li>Es correcto aplicar la misma ventana temporal a todos los pacientes ? </li></ul>
  48. 51. Cuales son los efectos de Dotrecogin alfa sobre las pruebas convencionales de coagulación y hemostasia ? <ul><li>Recomendaciones para pacientes con TTPA >100 segundos </li></ul><ul><li>Asegurar que se está administrando la dosis correcta </li></ul><ul><li>de Drotrecogin alfa (activada) , y que está ajustada al peso actual . </li></ul><ul><li>Reconsiderar la coadministración de heparina , y otros </li></ul><ul><li>anticoagulantes </li></ul><ul><li>Repetir tiempo de protrombina , INR , y recuento plaque- </li></ul><ul><li>tario ; un tiempo de protrombina elevado sugiere coagulopatía </li></ul><ul><li>asociada a la sepsis , pues Drotrecogin alfa (activada) alargaminimamente este tiempo. </li></ul><ul><li>Tratar la coagulopatía y el sangrado si se considera necesario </li></ul><ul><li>Si después de los pasos anteriores persiste el alargamiento del TTPA , suspender el fármaco dos horas y repetir las pruebas de coagulación , si persiste la alteración la causa es una coagulopatía asociada a la sepsis </li></ul><ul><li>Raramente el paciente con coagulopatía precisará un tratamiento que no sea la administración de productos sanguíneos y Drotrecogin alfa (activada) </li></ul><ul><li>Valorar riesgo beneficio en cada paciente , recordando el mayor beneficio de </li></ul><ul><li>Drotrecogin en el subgrupo de pacientes con coagulopatía </li></ul><ul><li>8. El TTPA no se recomienda para monitorizar el tratamiento con Drotrecogin </li></ul>
  49. 52. Vale pero si sangra o si … <ul><li>Qué factores influyen en la aparición de episodios hemorrágicos ? </li></ul><ul><li>Cómo prevenir los episodios de sangrado ? </li></ul><ul><li>Qué otros riesgos pueden estar asociados al tratamiento ? </li></ul>
  50. 53. Bueno …las últimas preguntas <ul><li>La colocación de un cateter epidural contraindica el uso de dotrecogin alfa ? </li></ul><ul><li>Se puede utilizar en obesos mórbidos ? </li></ul><ul><li>Se puede usar en pacientes en insuficiencia renal ? Y si tengo puesto un hemofiltro como modifico la pauta ? O no se modifica ? </li></ul><ul><li>Se puede usar en pacientes transplantados ? </li></ul><ul><li>Cual es su coste –beneficio ? </li></ul>
  51. 54. ¡ Nunca hay que conformarse ¡ ¡ Ellos no lo hicieron ¡
  52. 55. Proteina C activada en las guías
  53. 56. Objective: To determine the incidence and outcome of severe sepsis in the adult Finnish population and to evaluate how treatment guidelines in severe sepsis are applied in clinical practice. Study design: A prospective study in 24 closed multidisciplinary ICUs in 21 hospitals (4 university and 17 tertiary hospitals) in Finland. Patients: All 4,500 consecutive ICU admission episodes were screened for severe sepsis during a 4-month period (1 November 2004 – 28 February 2005). The referral population was 3,743,225.
  54. 58. PCA 15/470 3,2% 40 pacientes Sepsis grave CID DMO Mortalidad 6/15 40% Mortalidad 21/40 52,5%
  55. 59. Treatment compliance with the Sepsis Management Bundle's guidelines was poor. Recommended low-dose corticosteroid treatment was administered to fewer than one-half of the patients with septic shock. Treatment with aPC was given to only one-third of the patients with indications according to Finnish recommendations published in 2003. Blood cultures were absent nearly in one-third of patients. Ventilating acute lung injury/acute respiratory distress syndrome patients with low tidal volumes according to ARDSnet recommendations was poor
  56. 60. Recent studies have reported difficulty in implementing clinical guidelines in practice. Young MP, (2004) Ventilation of patients with acute lung injury and acute respiratory distress syndrome: has new evidence changed clinical practice? Crit Care Med 32:1260–1265 Rubenfeld GD, (2004) Barriers to providing lung-protective ventilation to patients with acute lung injury. Crit Care Med 32:1289–1293 Cabana MD, (1999) Why don't physicians follow clinical practise guidelines? A framework for improvement. JAMA 282:1458–1465
  57. 61. 101 consecutive adult patients with severe sepsis or septic shock The main outcome measures were: The rate of compliance with 6-hour and 24-hour sepsis care bundles adapted from the Surviving Sepsis Campaign guidelines on patients' clinical care. Difference in hospital mortality between the compliant and the non-compliant groups.
  58. 66. Compliance with 24-hour sepsis bundle and hospital mortality 71 critical care patients 69 (98%) were qualified for the 24-hour sepsis bundle for clinical care. 64% received glucose control < 8.3 mmol/ 43% had low-dose steroids given when requiring continued use of vasopressors Activated protein C was considered in only 30% of patients Plateau pressures were maintained < 30 cm H2O in 85% of ventilated patients. Rate of compliance was 30%. Hospital mortality was increased in the non-compliant group from 29% to 50%
  59. 67. Patients with severe sepsis who did not receive the 6-hour sepsis bundle for their early management had a twofold increase in hospital mortality The association between the use of a group of evidence-based interventions, improved outcomes. Efforts to improve hospital mortality from severe sepsis should focus on increasing compliance with these evidence-based interventions in appropriate patients.
  60. 68. El viaje comienza cuando crees que ha terminado…

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