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Albumin Replacement in Patients with Severe Sepsis or Septic Shock

Albumin Replacement in Patients with Severe Sepsis or Septic Shock. Caironi et al. NEJM 2014. ~66 kDa ~50% of plasma protein Metabolic half life ~19 days Turnover ~15 g/day ~10% of liver protein production 160 g extravascular 120 g intravascular. Albumin. Theoretical background.

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Albumin Replacement in Patients with Severe Sepsis or Septic Shock

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  1. Albumin Replacement in Patientswith Severe Sepsis or Septic Shock Caironi et al. NEJM 2014

  2. ~66 kDa ~50% of plasma protein Metabolic half life ~19 days Turnover ~15 g/day ~10% of liver protein production 160 g extravascular 120 g intravascular Albumin

  3. Theoreticalbackground • Maintains colloid osmotic pressure • Antioxidant and scavenger of ROS • Buffer in Acid-Base disorders • Carrier of drugs • Maintains endothelial glycocalyx and endothelial function • Remains longer in circulation

  4. Albumin - Cochrane • Metaanalysis • Resuscitation • Burns • Hypoalbuminaemia BMJ 1998;317:235-40

  5. Albumin - Cochrane • ’Albumin in critically ill patients should not be used outside the context of rigorously conducted RCT.’ Cochrane injury group. BMJ 1998;317:235

  6. Colloids in Denmark 1997-2005 SAFE Cochrane 1997 1998 1999 2000 2001 2002 2003 2004 2005

  7. Spontaneous bacterial peritonitis 126 patients Cefotaxim Cefotaxim + Albumin 1.5 g/kg at enrolment and 1g/kg on day 3 90-day mortality 41 vs 22% NEJM 1999;341:403-9

  8. Another meta analysis 55 trials 3504 patients

  9. Albumin - SAFE • Saline vs 4% albumin as resuscitaion fluid ~7.000 intensive care patients

  10. Albumin improves organ function

  11. Albumin improves organ function • 100 patients • Day 1: 300 ml Albumin 20% • Day 2 and-: 200 ml • Delta SOFA (Day 1 – 7) significantly higher • Respiratory • CVS • CNS

  12. ALBIOS • Italian multi center study (100 centres) • Investigatorinitiated • Randomizedopenlabel RCT

  13. Inclusioncriteria • Sepsis according to Bone • Two or more of the following: • a) a core temperature ≥ 38° C o ≤ 36° C; • b) a heart rate ≥ 90 beats/min; • c) a respiratory rate ≥ 20 breaths/min or PaCO2 ≤ 32 mmHg or use of mechanical • ventilation for an acute process; • d) a white blood cell count ≥ 12000/ml or ≤ 4000/ml or immature neutrophils > 10%. • Severe sepsis/ shock - SOFA > 1 • Except CVS ≥ 1 (adjusted to MAP < 65 mmHg) • GCS taken out of the score • Proved or suspected infection

  14. Protocol for 28 days or ICU discharge Albumin Crystalloid Only crystalloid Or ”emergency use based on standard criteria for each participating unit” • 300ml 20% albumin at randomization • If s-albumin < 25 g/L → 300ml 20% • If s-albumin > 25 < 30 g/L → 200ml 20% • If > 30 g/L no infusion EarlyGoalDirectedResuscitationinitially for both arms

  15. Randomization • 1818 pt randomized • 7 ex.in albumin group • 1 ex. in crystalloidgroup • 903 vs 907 analyzed • 28-days 895 vs 900 • 90-day 888 vs 893

  16. Stratification • Site • Before or after 6 hours of meeting inclusioncriteria

  17. Patient demographics

  18. Demographicscont.

  19. Results Albumin Crystalloid More crystalloid first week 16 vs. 14L • More albumin • 4,3% of daily fluids • Lower heart rate • first 3 days • Higher MAP • for 24h • Higher CVP • for 48h • Lower net fluid balance

  20. Albumin levels

  21. Net fluid balance

  22. Outcomes - primary

  23. Outcomes – secondary

  24. Outcomes - tertiary

  25. Outcomes – post hoc - secondary

  26. Outcomes – post hoc – primary

  27. Adjusted 90-day mortality Age, SOFA, lactate, ScVO2

  28. Outcomes – post hoc - prepublish

  29. Protocolviolations

  30. Pros & Cons • Multicenter study • Randomized • Stratified to center • Stratified to time of entry • Large • Interim extension of patients included • Single country study • Open label - Bias • Imbalance at baseline • More organ dysfunction in albumin group • (Higher baseline mortality?) • Post hoc analysis of septic shock patients

  31. Benefit for septic shock patients • In an underpowered, post hoc analysis of septic shock patients (of which the numbers have varied throughout the analysis of the study) a secondary outcome parameter was borderline significant in terms of improved survival.

  32. Questionsremaining • Resuscitation? • Is 30 g/l an adequate threshold • Long term effects of albumin • Are you better prepared for near future trauman • Septic shock patients – benefit • Yet another study? • Severe sepsis – negative outcome?

  33. Ongoingtrials • Lactated Ringer Versus Albumin in Early Sepsis Therapy (RASP) • Brazil • 360 patients • 4% albumin or Lactated Ringer within 6H of onset of sepsis • 7 day mortality

  34. Implications for the department • Should we stop using albumin? • Except for spontaneous bacterial peritonitis? • Albumin included in the budget from 2015 ?

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