rob mac sweeney's fficm hot topics talk march 2016
TRANSCRIPT
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Hot Topics.
FFICM Preparation Day London March 9th 2016
Rob Mac Sweeney
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http://bit.do/CCR-FFICM16
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Paul Young | Wellington
Saline or PlasmalyteIs SPLIT the Solution
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Hot Topics
•2016
•2015
•2014
•2013
•2012
•Major Research
•Major Guidelines
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Major Research Studies2016
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Sepsis 3DefinitionsProcess
Delphi ProcessDatabase validation
Screening with qSOAFIdentify with SOAF? Advance
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DIABOLOFrench multi-centre RCTEarly metabolic alkalosis382 patients
No separation MV | pH | PaCO2
↔ duration ventilation↔ duration weaning↓ bicarb & days with alkalosis
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Major Research Studies2015
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HEATParacetamol is harmful ?1g IV Paracetamol 6° or placebo700 ptsGroups well balanced↔ temperature (0.2°C)↔ ICU free days (23 v 22)Immunomodulatory effect ?
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PROPPRPragmatic multicentre RCT680 severely ill trauma patients1:1:1 with 1:1:2 FFP / Plt / RC↔ mortality:
Day 1Day 30
Reduced exsanguination
deaths1:1:2 group “caught up”
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SPLITCluster, crossover RCT0.9% Saline vs Plasmalyte2,278 ptsAll fluid administrative
purposes2000 ml each↔ AKI 9.2% v 9.6%Pilot study
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EUROTHERM> 20 mmHg for > 5 minutes32°C – 35°C vs standard mgtStage 2 387 patients∆ 2.14°C | ↓ stage 2 failure acOR 1.53 poor outcome GOS-
ETiming of intervention ?
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ABLEIs fresh blood better than old ?Young RBCs vs standard RBCs2430 patientsRBCs: 6 days vs 22 days90 day mortality: 37% vs 35%No 2° outcome differencesTRIGGER | RECESS
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EPO-TBIEPO pleotropic effects40,000 IU EPO x 3 or placeboWithholding criteria606 patients↔ GOS-E 1 - 4: 44% vs 45%↔ 6/12 mortality 11% vs 16%↔ DVT 16% vs 18%
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ProMISeOpen label, pragmatic RCTEarly septic shock
EGDT: SpO2 | ScvO2 | CVP |
MAP | Hb1,260 patientsSome separation↔ 90 day mortality: 29% vs
29%
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FLORALIOpen label, multi-centre RCTFM vs HFNO vs NIVSpO2 > 92%310 patients↔D28 reintubation 47 v 38 v
50%↓ ICU mortality 19 v 11 v 25%↓ D90 mortality 23 v 12 v 28%
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3SitesOpen label, RCT 10 French ICUs
Subclavian v I Jugular v FemoralCRBSI & symptomatic DVTExperienced clinicians3,471 catheters in 3,027 patients1.5 v 3.6 v 4.6 per 1000 cath
dayMechanical Complications
2.1% v 1.4% v 0.7%
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Amato StudyPost hoc review of 9 RCTsMultilevel Mediation AnalysisFunctional Lung SizeΔP = (Pplt – PEEP) = (Vt
/CRS)
Vt / Pplat / PEEP →ΔP
ΔP 7 cmH20 = ↑41% mortality
Requires validation
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Chlorhexidine BathingPragmatic, Cluster Randomized Crossover study
9340 patientsOnce daily 2% chlorhexidine2 x 10 week periods each↔ infections
55 vs 602.86 vs 2.90 / 1000 pt days
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Major Research Studies2014
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ALBIOSMulticentre Open Label RCT1795 patients with sepsis /
shock20% albumin + crystal vs crystalTarget serum albumin > 30g/l↔ 28 day mortality
Albumin: 31.8% vs 32%↔ 90 day mortality
Albumin: 41.1% vs 43.6%
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ARISE Australian / NZ RCTEGDT vs Usual CareRivers algorithm1600 patients with septic shock↔ 90 mortality
EGDT 18.6% vs 18.8%EGDT - ↑ fluids, vasopressors,
RC, dobutamine
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ProCESSAmerican multicentre RCT Testing Rivers EGDT protocolEDGT vs Standard vs Usual
care1341 patients with septic shock↔ day 60 mortality
21% vs 18.2% vs 18.9%↔ day 90 or 1 year mortality
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CALORIES Pragmatic, open label RCTEnteral vs Parenteral nutritionCould be fed by either route2400 emergency ICU pts↔ Day 30 mortality
PN: 33.1% vs EN: 34.2%PN – less hypos or vomiting
– no effect on infection
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CIRC Mechanical CPR vs Manual CPRUSA / European - OOHCA4753 randomized, 522 excluded↔ ROSC: 28.6% v 32.3%↔ 24 hour survival: 21.8% v 25%↔ Hosp discharge: 9.4% vs 11%
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LINC European open label RCTMechanical CPR & defibrillation2589 OOHCA patients↔ 4 hr survival: 23.6% vs 23.7%↔ CPC 1-2 survival
At ICU / Hospital dischargeAt 1 or 6 month
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HARP-2 Multicentre, UK/Ireland RCTSimvastatin vs Placebo540 patients with ARDS↔ Ventilator-free days↔ Non-pulmonary organ
failure -free days↔ 28 day mortality
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METAPLUS European multi-centre RCT301 pts expected ventilated >3/7Immune enhancing nutrientsHigh protein diet both groups↔ new infections (53% vs 52%)↑ 6/12 mortality with IMN
54% vs 35%
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PEITHO European Multi-centre RCT1,006 pts intermediate risk PETenecteplase & heparin vs
placebo & heparin↓ Death / CVS decompensation
2.6% vs 5.6%↔ Deaths: 1.2% vs 1.8%;
P=0.42↑ Stroke: 2.4% v 0.2%; ↑
Bleeding
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SEPSISPAMMulti-centre open label RCT776 pts with septic shockMAP 80 - 85 vs 65 – 70↔ D28 mortality 36.6% vs 34%↔ D90 mortality 43.8% vs 42.3%↔ serious adverse event↑ AF with higher BP↑ RRT with lower BP chronic
HTN
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TRISSEuropean multi-centre RCT1005 pts septic shock & anaemiaTransfuse Hb <9 g/dl vs <7 g/dlLess blood given (median 4 vs 1)↔D90 mortality (45% vs 43%)↔ischaemia / adverse events
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VITdAL-ICUAustrian single centre RCT492 white ICU pts Vit D deficientVit D vs Placebo↔ Hosp LOS 20 vs 19 days↔ Hosp / 6/12 mortalitySeverely deficient subgroup
↓ Hosp mortality 28% vs 46%↔ mortality at 6 months
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Major Research Studies2013
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TTM StudyMulti-centre RCT
950 OOHCA Patients
33°C vs 36°C
↔ All cause mortality
50% vs 48%
↔ Poor neuro function
54% vs 52%
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Kim StudyPrehospital cooling
1,359 OOHCA patients
↔ Survival to hosp discharge
VF 63% vs 64%
nonVF 19% vs 16%
↔ Good neuro recovery
VF 57% vs 62%
nonVF 14% vs 13%
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CATIS Study4,071 patients
Within 48 hrs ischemic stroke
Nonthrombolysed and ↑SBP
↑ BP Rx vs no BP Rx
BP control effective
↔ death and major disability
• 14 days / hosp discharge
• 3 months
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INTERACT2Early ICH & ↑SBP
SBP <140 mmHg vs <180
2,839 pts
Aggressive BP control lead to
Trend for adverse events
↓ modified Rankin scores
↔ mortality
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CRISTAL Stratified, open label RCTAny colloid vs any crystalloid2857 pts with hypovolaemic shock↔ 28 day mortality
25.4% vs 27%Less deaths with colloids at D90
30.7% vs 34.2%Less vasopressors / ventilation
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TracMan909 intubated patients
Tracheostomy timing
≤ 4 days vs > 10 days
↔ Mortality / ICU LOS
↔ Complications
Only 45% late group received trache
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β Blockade in Septic Shock154 septic pts with ↑HR & ↑dose
NA
Esmolol vs standard Rx
Esmolol
↓ HR / lactate / Norad / Fluids
↑ SVI / LVSWI
↓ D28 mortality (49% vs 80%)
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STATIN-VAP300 patients suspected VAP
Simvastatin 60 mg vs placebo
Study stopped early for futility
↔ 28 mortality
↔ Duration MV
↔ Δ SOFA
↑ mortality in statin naïve
21.5% vs 13.8%; p=0.054
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VSE Study 268 cardiac arrest ptsAdrenaline/Vasopressin/Methylpred
acutely & hydrocortisone later
VSE associated with improved
ROSC (84% vs 66%)
Good neuro recovery
14% vs 5%
21% vs 8%
(post resuscitation shock)
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PROSEVA466 patients with severe ARDS
Prone vs supine position
Prone position associated with
↓ mortality D28: 16% vs 33%
↓ mortality D90: 24% vs 41%
↓ cardiac arrests
↔ complications
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VILLANEAU• 921 pts with upper GI bleed
• Hb <7g/dL vs Hb <9g/dL transfusion
triggers
• Restrictive strategy:
• ↓ number of pts receiving
transfusion (15% vs 51%)
• ↑probability survival
• ↓ Less rebleeding / AEs
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REDOXS1,223 pts with MOF
Glutamine & antioxidants
Glutamine:
↑ mortality
D28 (34% vs 27%; p=0.05)
D90 (44% vs 37%; p=0.02)
Antioxidants ineffective
↔ Mortality / Other endoints
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OSCILLATE 548 pts with moderate-to-severe
ARDS
Trial terminated early
↑mortality 47% vs 35%
HFOV associated with
↑ sedation requirements
↑ neuromuscular blockade
↑ vasopressor support
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OSCAR795 pts with moderate-to-severe
ARDS
↔ Mortality 41% vs 41%
↔ Duration antimicrobials
↔ Duration pharmacological
vasoactive support
↔ LOS ICU or Hospital
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CRICS452 ventilated pts
No gastric volume monitoring
• ↔VAP (15.8% vs 16.7%)
• ↔ ICU-acquired infections
• ↔ Duration MV / ICU or Hospital
LOS
• ↑calorific goal (OR 1.77)
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SUNSET-ICUSingle-centre, block, randomised
trial
Resident nighttime intensivist
↔ ICU LOS
↔ Mortality
↔ Other endpoints
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Early Parenteral Nutrition
Early PN versus starvation
1,372 patients
Standard group: 40 % unfed
↔ 60 day mortality
↔ LOS – ICU or Hospital
PN: ↓ duration ventilation
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ReversalRetrospective observational
Looked at 10 years of NEJM
publications
Medical reversals – current practice
inferior to a prior standard
146/363 studies
40%
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Major Research Studies2012
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EN vs EN & PN305 critically ill patients
Day 3 & received <60% calorific goal
EN plus PN to achieve 100% calorific
target vs EN alone
EN plus PN associated with
↑ Calories: 28 vs 20 kcal/kg
↓ Infection: 27% vs 38%
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Best TRIP324 pts severe TBI
ICP guided vs clinical and imaging
guided management
↔ Composite of functional &
cognitive measures
↔ 6 month mortality (ICP
39% vs C&I: 41%)
↔ Length of stay
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CARRESS
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SLEAP Study423 pts
Protocolised sedation vs PS plus daily
sedation break
↔ Time to extubation
↔ ICU LOS / Hospital LOS
↔ Delirium / Unintended
extubations
PS & DSB: ↑sedation / nursing
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CHEST study7000 ICU pts
Fluid resuscitation with
6% HES 130/0.4 vs 0.9% saline
↔ Mortality (HES 18% vs 17%)
↔ LOS – ICU / Hospital
HES associated with increased
↑ RRT (7% vs 5.8%; RR 1.21)
↑ Pruritus / Rash / Liver failure
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6S Study804 severe sepsis pts
Fluid resuscitation
130/0.4 HES vs Ringer's acetate
HES associated with
↑ D90 death (51% vs 43%)
↑ RRT (22% vs 16%)
↑ bleeding (10 v 6%,p=0.09)
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IABP-II Study600 pts with acute MI & cardiogenic
shock
IABP vs no IABP
↔ D30 death (IABP 40 v 41%)
↔ Time to CVS stabilisation
↔ ICU LOS
↔ Catecholamines therapy
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PROWESS SHOCK Study1,697 pts with septic shock
↔ 28 day mortality
APC 26.4% vs 24.2%
↔ 90 day mortality
34.1% vs 32.7%
No subgroup effect seen
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Berlin Definition of ARDS
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MASH-21,204 pts within 4 days of
aneurysmal SAH
MgSO4 (64 mmol/day) vs placebo
↔Functional outcome
↔90 day mortality
MgSO4 26% vs 25%
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PRODEX / MIDEXMIDEX (n=500)
Dexmedetomidine v Midaz
Dexmedetomidine:
↓ duration ventilation
↑ patient interaction
↑ hypotension / bradycardia
↔ time at target sedation
↔ ICU / Hosp LOS / death
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PRODEX / MIDEXPRODEX (n=437)
Dexmedetomidine v Propofol
Dexmedetomidine:
↑ patient interaction
↔ time at target sedation
↔ Duration ventilation
↔ ICU / Hosp LOS // Death
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Fever Control200 pts with septic shock requiring
vasopressors
External cooling (36.5 to 37°C) vs not
Cooling was associated with
Early ↓ vasopressors
↑ ICU shock reversal
↓ 14 day mortality
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EDEN• 1000 pts early ALI
• Initial trophic EN vs full EN
Trophic feeding Δ -900 kcal/day
↔ Ventilator free days
↔ 60 day mortality
↔ Infectious complications
Full EN: ↑ GI complications
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LIFENOX8,307 acutely ill medical patients with
graduated compression stockings
subcutaneous enoxaparin (40 mg
daily) vs. placebo
↔D30 death (4.9% vs 4.8%)
↔Bleeding (0.4% versus 0.3%)
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BALTI-2
• 326 pts with ARDS
• salbutamol (15 μg/kg/h) vs. placebo
• Trial stopped early for safety
• ↑Mortality 34% vs 23%
Risk ratio 1.47
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Good Luck.
@critcarereviewshttp://bit.do/CCR-
FFICM16