5/31/2013 Year in Review: No disclosures Critical Care Medicine Eric J. Seeley, M.D. Assistant Professor of Medicine Division of Pulmonary and Critical Care Medicine Why I Selected These Studies… Question 1: • High quality studies What is the best way to ventilate • They answer a commonly patients with moderate to severe encountered clinical question ARDS? • They move care from anecdote to evidence 1
5/31/2013 Play with Play with ARDSNet ARDSNet ARDS ARDS Vent Vent Ventilation Ventilation Paralytics Paralytics Plan B Plan B Prone Prone APRV APRV Positioning Positioning HFOV iNO HFOV iNO ECLS ECLS 2 RCTS Evaluate High Frequency Oscillatory No Benefit, Potential Harm with HFOV in Ventilation in ARDS Moderate-Severe ARDS • OSCAR – NEJM Feb 2013, Young et al OSCAR OSCILLATE – Multicenter RCT: 29 Centers, UK – Enrolled 795 patients, P/F < 200 for >2 days – Randomized to Low Tidal Volume vs. HFOV (R100) • OSCILLATE Trial - NEJM Feb 2013, Ferguson et al – Multicenter RCT: 39 Centers, 5 Countries – Planned to enroll 1200 (stopped at 548) – Entry: new-onset ARDS with P/F < 200 – Randomized to Low Tidal Volume vs. HFOV (3100B) 2
5/31/2013 Play with ARDSNet ARDS Vent Ventilation Question 2: Paralytics Should I use low-tidal volume Plan B ventilation for all patients? Prone APRV Positioning HFOV iNO ECLS Background • Strong evidence supports the use of lung- Neto et al JAMA Oct 24/31, 2012- Vol 308, No 165 protective ventilation for patients with ARDS • Study Design (NEJM 2000) – Meta-Analysis • 20 studies with a total of 2822 patients • Studies performed in the OR, MICU, SICU, NICU • HOWEVER , could patients benefit from lung • Primary reason for intubation was schedule surgery • Included 15 RCTs, 5 were cross-sectional or cohort studies protective ventilation if they are at risk for • Average Tidal Volume ARDS? Might they benefit even if there is no – Protective 6.45 ml/kg vs. Conventional 10.60 ml/kg (P<0.001) • Follow: 3hrs->10 days clear risk factor for ARDS? • Outcomes: Lung Injury, Mortality, Pulmonary Infection, Atelectasis 3
5/31/2013 Question 2: Neto et al JAMA Oct 24/31, 2012- Vol 308, No 165 Should I use low-tidal volume Pulmonary Lung Injury Mortality Atelectasis Infection ventilation for all patients? RR for 0.33 0.64 0.52 0.62 low V T p-value <0.001 0.007 0.005 0.03 Answer: Yes, unless there is a compelling contraindication Low V T better High V T better Early versus Late Parenteral Nutrition in Critically Ill Adults Casaer, M.P. NEJM 365(6): Aug 2011 Question 3: • Study Design Should I rush to start TPN on my – Randomized Multicenter Trial in Belgium – 4600 patients at nutritional risk who were not patient who cannot tolerate enteral chronically malnourished feeds? • (majority were surgical patients) – Randomized to early (<48 h) vs. late ( 1 wk) TPN to meet nutritional needs in at risk patients – Compared guidelines in Europe (early) vs. N. America (late) 4
5/31/2013 Early versus Late Parenteral Nutrition Early versus Late Parenteral Nutrition in Critically Ill Adults Casaer, M.P. NEJM 365(6): Aug 2011 in Critically Ill Adults Casaer, M.P. NEJM 365(6): Aug 2011 Late-Initiation Early-Initiation P Value Death at 90 Days 11.2% 11.2% 1.00 Discharge Alive from ICU within 8 days 75.2 % 71.7 % 0.007 Duration of ICU Stay (days) 3 (2-7) 4 (2-9) 0.02 Duration of hospital stay (median) 14 (9-27) 16 (9-29) 0.004 New Infection 22.8 26.2 0.008 Median duration of RRT (days) 7 (3-6) 10 (5-23) 0.04 Mean total incremental health care cost 16,863 17,973 0.04 Days After Enrollment Doig et al JAMA May 2013 Doig et al JAMA May 2013 • Multicenter RCT in Australia/New Zeland • Enrolled 1372 patients with relative contraindications to early enteral nutrition who were expected to be in the ICU > 2days • Randomized to standard practice vs. TPN w/in 24 hours of ICU admission • Super Early TPN 5
5/31/2013 Question 3: Doig et al JAMA May 2013 Should I start TPN on my patient who can’t tolerate enteral feeds? Early-PN Standard Care P Value 60 day mortality 21.5% 22.8% 0.60 Duration of ICU stay (d) 8.6 (8.2-9.0) 9.3 (8.9-9.7) 0.06 Answer: No need to provide super Duration of hospital stay (d) 25.4 (24.4-26.6) 24.7 (23.7-25.8) 0.5 early or early TPN, but try to feed New Infection 10.9% 11.4% .91 enterally as soon as possible Background • 1999 NEJM TRICC trial Question 4: – Liberal Transfusion • Trigger Hb of 10 g/dl In actively bleeding patients, what is a • Goal Hb 10-12 g/dl – Restrictive Transfusion reasonable transfusion threshold? • Trigger Hb 7 g/dl • Goal Hb 7-9 g/dl • These patients were euvolemic • ACTIVELY BLEEDING PATIENTS WERE EXCLUDED • What do we do with actively bleeding patients? 6
5/31/2013 Transfusion Strategies for Acute Upper Transfusion Strategies for Acute Upper Gastrointestinal Bleeding Gastrointestinal Bleeding Villanueva C et al. NEJM, 2013;368:11-21 Villanueva C et al. NEJM, 2013;368:11-21 • RCT single center in Spain • Enrolled 921 patients with UGIB Trigger = Hb <7 • Randomized to: – Transfusion trigger of Hb 7 g/dl vs. 9 g/dl – Stratified by presence of cirrhosis Trigger = Hb <9 • Primary outcome was 45 day survival • Secondary outcomes: further bleeding Villanueva C et al. N Engl J Med 2013;368:11-21 Transfusion Strategies for Acute Upper Question 4: Gastrointestinal Bleeding Villanueva C et al. NEJM, 2013;368:11-21 In actively bleeding patients, what is a reasonable transfusion threshold? Restrictive Liberal P Value Death at 45 Days 5% 9% 0.02 Further Bleeding 10% 16% 0.01 Answer: Number of days in hospital 9.6 11.5 0.01 Adverse events (any) 40% 48% 0.02 FOR UPPER GIB Transfusion associated cardiac overload <1 4 0.001 Utilize a threshold of Hb < 7 Cardiac Complications 11% 16% 0.04 Villanueva C et al. N Engl J Med 2013;368:11-21 7
5/31/2013 Based on these 6 papers… • HFOV should be eliminated from the treatment algorithm for moderate-severe ARDS Questions? • Lung protective ventilation can be widely employed in the ICU • Initiation of TPN in patients who are at nutritional risk can be “delayed” • In actively bleeding patients with UGIB a transfusion trigger of Hb < 7 can be used 8
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