Goal Directed Therapy

Transcription

1 Goal Directed Therapy Dr Maurizio Cecconi MD FRCA FFICM MD(Res) Consultant and Reader Anaesthesia and Intensive Care Medicine St George s University Hospital NHS Foundation Trust St George s University of London

2 Disclosure Edwards Lifesciences LiDCO Cheetah Medical Masimo Bmeye Deltex Applied Physiology

3 Randomised controlled trials with PAC use in one group Author Year Protocol PAC outcome Shoemaker 1988 YES Better Boyd 1993 YES Better Wilson 1999 YES Better Lobo 2000 YES Better Polonen 2000 YES Better Rhodes 2002 NO no difference Sandham 2003 Guidelines no difference Richard 2003 NO no difference Harvey 2005 NO no difference

4 Randomised controlled trials with PAC use in one group Author Year Protocol PAC outcome Shoemaker 1988 YES Better Boyd 1993 YES Better Wilson 1999 YES Better Lobo 2000 YES Better Polonen 2000 YES Better Rhodes 2002 NO no difference Sandham 2003 Guidelines no difference Richard 2003 NO no difference Harvey 2005 NO no difference

5 Randomised controlled trials with PAC use in one group Author Year Protocol PAC outcome Shoemaker 1988 YES Better Boyd 1993 YES Better Wilson 1999 YES Better Lobo 2000 YES Better Polonen 2000 YES Better Rhodes 2002 NO no difference Sandham 2003 Guidelines no difference Richard 2003 NO no difference Harvey 2005 NO no difference

6 Identification of a high risk population Haemodynamic monitoring + Strategy

7 Major complications in major surgery % 10% Incidence Mortality Gawande; Surgery 1999,126,66-75 Kable; Int J Qual Health Care 2002,14, Ghaferi et al. N Engl J Med 2009

8 438 Elective operations: Major orthopedic Major general Major urological Major vascular Major gynecological Incidence of complications?

9 30 27% % 0 Mortality Complications St George s University Hospitals NHS Foundation Trust, Bennett-Guerrero Critical Care Directorate Anesth Research Analg 1999

10 Consequencies of a postoperative complication?

11 8 Operations Ann Surg 2005;242: AAA Infrainguinal Vascular reconstruction Carotid endarterectomy Colectomy Open Cholecystectomy Laparoscopic Cholecystectomy Lobectomy/Pneumonectomy Total Hip replacement

12 Khuri et al. Ann Surg 2005;242:

13 Khuri et al. Ann Surg 2005;242: Patients with no complications Patients with complications

14 Khuri et al. Ann Surg 2005;242: Patients with no complications Patients with complications

15 The occurrence of a 30 day postoperative complication is more important than preoperative patient risk and intraoperative factors in determining survival after major surgery Khuri et al. Ann Surg 2005;242:

16 Dimick et al J Am Coll Surg 2004

17 Mortality Hamilton MA, Cecconi M, Rhodes A Anaesthesia & Analgesia 2011

18 Complications

19 Hamilton MA, Cecconi M, Rhodes A Anaesthesia & Analgesia 2011 Control Group Mortality

20 Goal directed therapy: what is the evidence in surgical patients? The effect on different risk groups Maurizio Cecconi, Carlos Corredor, Nishkantha Arulkumaran, Gihan Abuella, Jonathan Ball, Michael R Grounds, Mark Hamilton and Andrew Rhodes Crit Care 2013

21 Mortality effect based on risk group Mortality less than 5 % Mortality 5 to 20% Mortality higher than 20% Cecconi et al. Crit Care 2013

22 Morbidity effect based on risk group Mortality less than 5 % Mortality 5 to 20% Mortality higher than 20% Cecconi et al. Crit Care 2013

23 Rhodes A, Cecconi M, Hamilton M et al ICM years survival Protocol vs Control Median increase in survival 1107 days (> 3 years) Hazard ratio 1.8 (95% CI 1.2 to 2.8)

24 Cost Effectiveness Analysis QALY Cost effectiveness Ratio

25 QALY Scale from 0 to1 0 equates to death 1 to full health Hip replacement 0.7 first year post recovery 0.8 for 2 years 0.9 for next 2 years 4.1 = 0.7 x x x 2 Ebm C, Sutton L, Rhodes A and Cecconi M In Press JCVA 2014

26 QALY Scale from 0 to1 No Hip replacement 0 equates to death 1 to full health 3.85 = 0.77 x 5 Surgery vs no Surgery total QALY 4.1 vs 3.85 Ebm C, Sutton L, Rhodes A and Cecconi M In Press JCVA 2014

27 Costs More Cost Less Benefit More Cost More Benefit If the ICER is below an accepted threshold we Effect accept the new therapy Less Cost Less Benefit Less Cost More Benefit: Cost Saving St George s University Ebm Hospitals C, Sutton NHS Foundation L, Rhodes Trust, A Critical and Cecconi Care Directorate M In Research Press JCVA 2014

28 Cost effectiveness A cost-effectiveness analysis of postoperative goal directed therapy for high-risk surgical patients Claudia Ebm, Maurizio Cecconi, Les Sutton and Andrew Rhodes Critical Care Medicine 2014

29 A cost-effectiveness analysis of postoperative goal directed therapy Cost effectiveness for high-risk surgical patients Claudia Ebm, Maurizio Cecconi, Les Sutton and Andrew Rhodes Critical Care Medicine

30 Randomized controlled trial of intraoperative goal directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery C Challand et al BJA 2011 Patients undergoing CPEX testing preop Intraop GDT vs CTRL Analysis for GDT vs CTRL in overall/fit and unfit

31 CTRL GDT Difference p Complications ns Serious Complications Surgical readiness for discharge (days) Total postoperative stay (days) Critical Care Admission 6 6 ns Colloid Overload in fit patients? 4.7 ( ) 7.0 ( ) ( ) 8.8 ( ) C Challand et al BJA 2011

32 Effect of a Perioperative, Cardiac Output Guided Hemodynamic Therapy Algorithm on Outcomes Following Major Gastrointestinal Surgery A Randomized Clinical Trial and Systematic Review Rupert M.Pearse,MD; DavidA. Harrison,PhD; Neil MacDonald,FRCA; Michael A.Gillies,FRCA; Mark Blunt,FRCA; Gareth Ackland,PhD; Michael P.W.Grocott,MD; Aoife Ahern,BSc; Kathryn Griggs,MSc; Rachael Scott,PhD; Charles Hinds,FRCA; Kathryn Rowan,PhD; for the OPTIMISE Study Group JAMA 2014 Difference Non significant

33 Timing recruitment GDT Standard care OR p First 10 patients 33 (42.3%) (n=78) 28 (34.1%) (n=82) 1.51 ( ) Without first 10 patients 100 (35.0%) (n=286) 129 (46.7%) (n=276) 0.59 ( ) A prespecified analysis of timing of recruitment suggested that a learning curve may have existed removing first 10 patients per site the results are significant St George s University Hospitals NHS Foundation Pearse Trust, Critical et Care al. Directorate JAMA Research 2014

34 Timing recruitment GDT Standard care OR p First 10 patients 33 (42.3%) (n=78) 28 (34.1%) (n=82) 1.51 ( ) Without first 10 patients 100 (35.0%) (n=286) 129 (46.7%) (n=276) 0.59 ( ) A prespecified analysis of timing of recruitment suggested that a learning curve may have existed removing first 10 patients per site the results are significant St George s University Hospitals NHS Foundation Pearse Trust, Critical et Care al. Directorate JAMA Research 2014

35 Cardiac complications associated with goal-directed therapy in high-risk surgical patients: a meta-analysis N. Arulkumaran, C. Corredor, M. A. Hamilton, J. Ball, R. M. Grounds, A. Rhodes and M. Cecconi BJA 2014 Is GDT safe?

36 100% 90% 90% Intra-op GDFT (%) 83% Courtesy of Nial Quiney 80% 70% 60% 50% 48% 54% 49% Pre-ELPQuiC 40% Post-ELPQuiC 30% 29% 20% 16% 10% 0% Site 1 Site 2 Site 3 Site 4 5% ELPQuiC Emergency Laparotomy Pathway Quality Improvement Care-Bundle

37 25% 30-day mortality Courtesy of Nial Quiney 20% 20.4% 25% reduction 15% 10% 13.5% 14.0% 13.2% 13.6% 13.3% 8.2% 7.8% 14.9% 11.2% Pre-ELPQuiC Post-ELPQuiC 5% 0% Site 1 Site 2 Site 3 Site 4 All ELPQuiC Emergency Laparotomy Pathway Quality Improvement Care-Bundle

38 Bundles Treatments: Marginal gain theory There's fitness and conditioning, of course, but there are other things that might seem on the periphery: like sleeping in the right position having the same pillow when you are away and training in different places

39 The IMPRESS-SSC Study An International Multi-Centre Prevalence Study of Sepsis Top Countries 1. USA 2. United Kingdom 3. Malaysia 4. Spain 5. India 6. Italy 7. China 8. Brazil 9. Greece 10. Belgium November 7 th Countries from all continents 1794 Patients

40 The IMPRESS-SSC Study An International Multi-Centre Prevalence Study of Sepsis 3 Hour Bundle Compliance 19% Overall % Compliance Measurement of Lactate 56 Obtain Blood Cultures Prior to Antibiotics 49 Administer Broad Spectrum Antibiotics 64 Administer 30 ml/kg crystalloid for hypotension 57 6 Hour Bundle Compliance 36% Overall % Compliance Apply vasopressors 66 Measure CVP 57 Measure ScvO2 47

41 Hospital Mortality (%) by Bundle Compliance P<0.001 P<0.001

42 Conclusions No specific RCTS in Emergency Laparotomies Evidence suggests consistent benefit in highest mortality risk groups (>5%) Unlikely to cause harm Cost-effectiveness? No magic bullet, only as part of high quality care