goal directed therapy - emergency laparotomy...

St George’s University Hospitals NHS Foundation Trust, Critical Care Directorate Research

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


Disclosure

• Edwards Lifesciences

• LiDCO

• Cheetah Medical

• Masimo

• Bmeye

• Deltex

• Applied Physiology


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

Randomised controlled trials with PAC use in one group


Identification of a high risk population Haemodynamic monitoring + Strategy


Major complications in major surgery

0

10

20

30

40

50

60

70

80

90

100

Incidence Mortality

16%

10%

Gawande; Surgery 1999,126,66-75 Kable; Int J Qual Health Care 2002,14,269-76 Ghaferi et al. N Engl J Med 2009


438 Elective operations:

Major orthopedic Major general Major urological Major vascular Major gynecological

Incidence of complications?

St George’s University Hospitals NHS Foundation Trust, Critical Care Directorate Research Bennett-Guerrero Anesth Analg 1999

0

5

10

15

20

25

30

Mortality Complications

1.6%

27%


Consequencies of a postoperative complication?


Ann Surg 2005;242: 326–343

8 Operations

• AAA

• Infrainguinal Vascular reconstruction

• Carotid endarterectomy

• Colectomy

• Open Cholecystectomy

• Laparoscopic Cholecystectomy

• Lobectomy/Pneumonectomy

• Total Hip replacement


Khuri et al. Ann Surg 2005;242: 326–343



Patients with no complications Patients with complications


“The occurrence of a 30 day postoperative complication is more important than preoperative patient risk and intraoperative factors in determining survival after major surgery”



Dimick et al J Am Coll Surg 2004


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


Complications


Control Group Mortality

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


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


Cecconi et al. Crit Care 2013

Mortality effect

based on risk group

Mortality 5 to 20%

Mortality less than 5 %

Mortality higher than 20%


Mortality 5 to 20%

Mortality less than 5 %

Mortality higher than 20%

Morbidity effect

based on risk group

Cecconi et al. Crit Care 2013


15 years survival Protocol vs Control

Rhodes A, Cecconi M, Hamilton M et al ICM 2011

Median increase in survival 1107 days (> 3 years) Hazard ratio 1.8 (95% CI 1.2 to 2.8)


Cost Effectiveness Analysis

• QALY

• Cost effectiveness Ratio


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 1 + 0.8 x 2 + 0.9 x 2

Ebm C, Sutton L, Rhodes A and Cecconi M In Press JCVA 2014


QALY

Scale from 0 to1 0 equates to death

1 to full health

No Hip replacement

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

St George’s University Hospitals NHS Foundation Trust, Critical Care Directorate Research Ebm C, Sutton L, Rhodes A and Cecconi M In Press JCVA 2014

Costs

Effect

Less Cost More Benefit:

Cost Saving

Less Cost Less Benefit

More Cost Less Benefit

More Cost More Benefit

If the ICER is below an accepted threshold we accept the new therapy


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


Cost effectiveness

1325£ 280£ 525£

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


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

St George’s University Hospitals NHS Foundation Trust, Critical Care Directorate Research C Challand et al BJA 2011

CTRL GDT Difference p

Complications 38 42 ns

Serious Complications

6 6 ns

Surgical readiness for

discharge (days) 4.7 (3.0-7.8) 7.0 (4.7-9.6) +2.3 0.01

Total postoperative

stay (days) 6.0 (4.1-9.8) 8.8 (6.8-11.0) +2.8 0.01

Critical Care Admission

5 14 0.03

Colloid Overload in fit patients?


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

St George’s University Hospitals NHS Foundation Trust, Critical Care Directorate Research Pearse et al. JAMA 2014

“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

Timing recruitment

GDT Standard care OR p

First 10 patients 33 (42.3%) (n=78)

28 (34.1%) (n=82)

1.51 (0.75-3.01)

Without first 10 patients

100 (35.0%) (n=286)

129 (46.7%) (n=276)

0.59 (0.41-0.84) 0.019


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?


ELPQuiC Emergency Laparotomy Pathway Quality Improvement Care-Bundle

48%

16%

29%

5%

90%

54%

83%

49%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Site 1 Site 2 Site 3 Site 4

Intra-op GDFT (%)

Pre-ELPQuiC

Post-ELPQuiC

Courtesy of Nial Quiney


ELPQuiC Emergency Laparotomy Pathway Quality Improvement Care-Bundle

20.4%

14.0% 13.6% 13.3% 14.9%

13.5% 13.2%

8.2% 7.8%

11.2%

0%

5%

10%

15%

20%

25%

Site 1 Site 2 Site 3 Site 4 All

30-day mortality

Pre-ELPQuiC

Post-ELPQuiC

25% reduction

Courtesy of Nial Quiney


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…”


November 7th 2013 62 Countries from all continents 1794 Patients

Top Countries 1. USA 2. United Kingdom 3. Malaysia 4. Spain 5. India 6. Italy 7. China 8. Brazil 9. Greece 10. Belgium

The IMPRESS-SSC Study An International Multi-Centre Prevalence Study of Sepsis


3 Hour Bundle Compliance % 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 % Compliance

Apply vasopressors 66

Measure CVP 57

Measure ScvO2 47

19% Overall Compliance

36% Overall Compliance

The IMPRESS-SSC Study An International Multi-Centre Prevalence Study of Sepsis


Hospital Mortality (%) by Bundle Compliance

P<0.001 P<0.001


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

goal directed therapy - emergency laparotomy...

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