Year in Review 2014: Critical Care Medicine
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1 Disclosures Year in Review 2014: Critical Care Medicine I receive laboratory support from CytoVale Diagnostics for research on early sepsis diagnostics Eric J. Seeley, M.D., F.C.C.P. Assistant Professor of Medicine Division of Pulmonary and Critical Care Medicine University of California, San Francisco I am a co-site PI for Pulmonx and PneumRx bronchoscopic lung volume reduction studies Why I Selected These Studies Rigorously conducted large RCTs They were published in major journals They answer common Yeah, buts There are many Yeah but s when it comes to key therapies in CCM Yeah, but in the EGDT trial (Rivers), it was unclear if RBCs and ScvO 2 guided therapy helped and wasn t it single center trial with a COI involving the Edward s catheter? Yeah, but in a septic patients with low albumin, subgroup analysis suggests that albumin resuscitation has a mortality benefit (SAFE Trial). Yeah, but in patients who are hypertensive at baseline, shouldn t we target a higher MAP goal? Yeah, but wasn t there a study in the NEJM that suggests a mortality benefit to thrombolysis in sub-massive PE 1
2 Yeah, but in the EGDT trial (Rivers), it was unclear if RBCs and ScvO 2 guided therapy helped and wasn t it single center trial with a COI involving the Edward s catheter? NEJM 2014 Rivers EGDT NEJM 2001 Single center study of 263 pts Mortality in EGDT 30.5% vs 46.5% Widely adopted in clinical practice Kind of Adopted into the surviving sepsis guidelines All of these unanswered?s led to ProCESS Multicenter, RCT in US 31 ERs, 1341 Patients with Septic Shock 2 SIRS + SBP < 90 despite fluid or lactate > 4 Randomized to 1 of 3 protocols in first 6 hours 1.Early Goal Directed Therapy (EGDT) - River s protocol (ScVO2, Blood, Dobutamine) 2.Protocol-Based Standard Therapy - River s light (CVC as needed, less blood, no ScVO2 goal) 3.Usual Care - What ERs in academic centers usually do EGDT Protocol Vs. Protocol Based STD Rivers light What Actually Happened? Edwards Catheter Hct >30 Dobut if ScvO 2 <70% No CVP Hct >21 No ScvO 2 goal Shock Index = HR/SBP Central Line Insertion Scv0 2 Monitoring IVF Volume 2
3 No Difference in 60 day or 1 year cumulative mortality Take away - No need for: Edwards Catheter (put next to the PA-Catheter) Transfusion goal of Hct >30% (Hct 21 better) Dobutamine guided by ScvO 2 Central line NOT ESSENTIAL for hemodynamic monitoring (i.e. CVP probably as bad as we think) NEJM 2014 ALBIOS Study Investigators (Caironi, Gattinoni) March 18, NEJM 2014 ALBIOS Study Investigators (Caironi, Gattinoni) March 18, NEJM 2014 Yeah, but in septic patients with low albumin, subgroup analysis suggests that albumin has a mortality benefit SAFE trial (2004): NS vs. 4% Albumin in Critically Ill Severe sepsis subgroup lower risk of death but p > 0.05 ALBIOS Study Design 100 ICUs in Italy, 1818 pts with severe sepsis/septic shock 20% albumin and crystalloid vs. crystalloid alone Target was Albumin > 30 g/l (3.0 g/dl) Primary outcome was death at 28 days 3
4 ALBIOS Study Investigators (Caironi, Gattinoni) March 18, NEJM 2014 ALBIOS Study Investigators (Caironi, Gattinoni) March 18, NEJM 2014 Take Away Hard to justify added expense of Albumin for sepsis resuscitation SEPSISPAM Investigators* NEJM March 2014 SEPSISPAM Investigators* NEJM March 2014 Yeah, but in patients who are hypertensive at baseline, shouldn t we target a higher MAP goal? Surviving sepsis guidelines recommend MAP > 65 in patients with septic shock Based on human/animal studies of lactate and RBF Trial Design Multi-center RCT in French ICUs 776 patients with septic shock Randomized to MAP > 65 vs. MAP > 85 >85 >65 4
5 SEPSISPAM Investigators* NEJM March 2014 SEPSISPAM Investigators* NEJM March 2014 P=0.57 You could consider higher MAP goals in patients with chronic HTN who are at low risk for afib. P=0.57 JAMA April 2014 JAMA April ,064 patients in Australia/NZ with severe sepsis/septic shock 101,064 patients in Australia/NZ with severe sepsis/septic shock But it s not all bad news But it s not all bad news 5
6 How do we treat submassive PE? How do we treat submassive PE? Heparin +/- Thrombolytics? PE Heparin Heparin +/- Thrombolytics? How do we treat submassive PE? How do we treat submassive PE? Massive PE: Heparin + Thrombolytics Massive PE: Heparin + Thrombolytics PE Heparin Heparin +/- Thrombolytics? PE Heparin Heparin +/- Thrombolytics? Sub-massive/ Intermediate PE Therapy Unclear 6
7 Yeah, but there was a study in the NEJM that suggest a mortality benefit to thrombolysis in sub-massive PE Event = Composite End Point Konstantinides NEJM 2002 MAPPET-3 Trial ***Composite Primary End-point driven only by secondary thrombolytics****** NEJM 2014 PEITHO investigators Multi-center RCT in Europe 1005 patients with Intermediate Risk-PE HD Stable with RV dysfunction and + trop Randomized to: Tenectaplase + Heparin vs. Heparin alone Primary Outcome Death or hemodynamic collapse 7 days after txt Conclusions: Ending the Yeah, buts For Septic Patients You can do away with ScvO 2 and CVP guided therapy There is no benefit to a higher Hb goal in EGDT No benefit to Albumin in sepsis resuscitation No benefit to MAP > 85 except in chronic HTN For Intermediate/Submassive PE Probably better to start with Heparin and thrombolyse for hemodynamic decompensation (ie. Only for massive PE) Stroke Patients, 8/10 were >70 yo. Youngest was 65, 4/10 survived 7
8 Questions? 8
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