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Highlight from Brussels Meeting

Highlight from Brussels Meeting. Anne Leung QEH ICU 28 th Apr 2009. Overview. Nice Sugar Study RENAL Study Surviving Sepsis Campaign ( Pros & Cons debate) Trac-Man Study. NICE-SUGAR.

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Highlight from Brussels Meeting

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  1. Highlight from Brussels Meeting Anne Leung QEH ICU 28thApr 2009

  2. Overview • Nice Sugar Study • RENAL Study • Surviving Sepsis Campaign ( Pros & Cons debate) • Trac-Man Study

  3. NICE-SUGAR • Normoglycaemia in Intensive Care Evaluation & Survival Using Glucose Algorithm Regulation • By Australian and New Zealand Intensive Care Society • Canadian Critical Care Trials group • University of Sydney • University of British Columbia

  4. To begin the story…….

  5. 33% relative reduction in risk of in-hospital death

  6. Intensive Insulin Therapy in the Medical ICU---NEJM 2003

  7. Intensive Insulin Therapy and Pentastarch Resuscitation in Severe Sepsis— NEJM 08

  8. Benefit and Risks of Tight glucose Control in Critically Ill Adults: A Meta-analysis JAMA 2008 • In critically ill adult patients, tight glucose control is • -not associated with significant reduced hospital mortality, • -but increased risk of hypoglycemia!

  9. Nice Sugar Study • Aim • To compare the effect of two blood glucose targets on 90-day all cause mortality in patients who are predicted to stay at ICU > 3 days • Hypothesis • No difference in the relative risk of death between patients assigned glucose range of 4.5-6.0 mmol/L and those assigned the range of <10.0 mmol/L

  10. A Priori subgroup pairs • 1. Operative vs non-operative • 2. DM vs not • 3. Severe sepsis vs not • 4. Trauma vs Non-trauma • 5. APACHE >25 vs APACHE<25 • 6. Systemic corticosteroid treatment for >72 hours or not

  11. Flow of patients through study

  12. Average (95% CI) time-weighted blood glucose

  13. Severe hypoglycaemia (2.2 mmol/L)

  14. Outcomes: Mortality

  15. Survival

  16. Survival

  17. Proximate cause of death: All cardiovascular

  18. Secondary and Tertiary Outcomes

  19. Mechanism: Differences between the groups • Reduced blood glucose concentration • Increased insulin dosage • Increased severe hypoglycemia • Increased corticosteroid administration • Greater proportion of deaths due to cardiovascular causes

  20. Mechanism: methodological issues • Greater statistical power: • Nice Sugar 829 vs 751 deaths • Van den Berghe MICU 214 vs 228 deaths • All 1681vs 1681 deaths • Longer follow-up • Difference in death not significant at 28 days • Specific effect of the algorithm • Can not exclude this

  21. To whom do the results apply? • Adult ICU patients expected to be in ICU for 3 consecutive days and who are likely to be eating on day after admission • Patients who received predominately enteral nutrition • Operative and non-operative admissions • Diabetics and non-diabetics • Patients with severe sepsis

  22. Conclusions • Blood glucose target of 4.5-6.0 mmol/L resulted in increased mortality compared to a target of <10.0 mmol/L • In comparison with other trials, severe hypoglycaemia was relatively uncommon but significantly more common in those assigned to intensive glucose control • On the basis of these results we do not recommend targeting normoglycaemia in critically ill patients

  23. The way forward……. • How to set the blood glucose target in our unit? • <10 mmol/L • 8-10 mmol/L • 6-10 mmol/L • Wait and watch!

  24. To begin the “Dosing” story of CRRT…. Lancet 2000

  25. Higher the dose the better Piccinni ICM 2006 EIHF vs Conventional 45mL/Kg/hr for 6 hours then 20mL/Kg/hr vs 20mL/Kg/hr 28-day Survival: 55% vs 27.5%

  26. CVVHDF: more = equal Tolwani et al JASN 2008 PRCT Single Center N=200 Prediultion CVVHDF: 20mL/Kg/Hr CVVDHF: 35mL/Kg/Hr

  27. Intensive RRT = Equal ATN trial PRCT N=1124

  28. What Dose • Before the ATN trial • CRRT: 35mL/Kg/Hr • Daily iHD • After the ATN trial • SOFA 0-2: 3x/week iHD (Kt/V 1.2) • SOFA 3-4: CRRT 20 mL/Kg/hr or SLED 3x/week • But beware for the need for extra treatment!

  29. RENAL Study • Control arm “dose” = current practice • Treatment arm = a dose between the 2 higher Lancet doses • Adequate dose separation between the 2 arms • Post-dilution rather than pre-dilution • CRRT technique had to be feasible for the available machines • Standardized membranes and fluid replacement

  30. Intervention • CVVHDF for all patients • Post dilution fluid replacement • Effluent flow of 25 ml/Kg/Hour ( low dose) • Effluent flow of 40ml/Kg/hour (high dose) • Blood flow > 150 ml/min • AN 69 membrane filter • Use bicarbonate base dialysate and replacement fluid

  31. RENAL Study

  32. Process of Care

  33. Result of RENAL Study

  34. Outcomes

  35. Secondary Outcomes

  36. Renal Outcome

  37. Serious Adverse Effects

  38. Conclusions • RENAL is the largest multi-centre RCT of intensity of CRRT in ICU patients with acute kidney injury • It successfully achieved balanced randomization as shown by baseline features • It successfully delivered two different intensities of CRRT with excellent group separation

  39. Conclusions • Higher Intensity CRRT did not affect survival • Higher CRRT intensity did not affect secondary outcome measures • No evidence of different effects in different subgroups • Cost implication: • Saving in low dose of AUD 500 per patient • >AUD 700,000 at 35 centres • Probably >AUD 1M across Australia and New Zealand

  40. Comparison with VA/NIH Study

  41. Summary • Largest multi-centre RCT of intensity of CRRT in ICU patient with AKI • Excellent outcomes • Mortality • Renal recovery • LOS in ICU and hospital • Length of dialysis and ventilation • Increasing intensity above 25 ml/Kg/hr did not improve any outcome • And associate with increased cost and adverse events

  42. [Pro-con debate] Hemodynamic management according to the Surviving Sepsis Campaign CON Azriel Perel Professor and Chairman Department of Anesthesiology and Intensive Care Sheba Medical Center, Tel Aviv University Israel ISICEM Brussels 2009

  43. The revised SSC guidelines include 85 recommendations (instead of the original 52 that appeared in 2004)

  44. Summary of 12 centers (1,298 patients) Pre-implementation 44.8% Post-implementation 24.5% Absolute risk reduction - 20.3% !!!

  45. 38th SCCM Conference Perspectives Sepsis-associated mortality decreased from 37% to 30% during a 24-month period at hospitals that implemented all the Surviving Sepsis Campaign protocols. A crude adjustment for severity of illness revealed an absolute mortality difference of 5.4%. M. Levy, SCCM 2009

  46. Rivers, NEJM, 2001 CCM, 2006;34:2707

  47. Crit Care Med 2006; 34:1589–1596

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