What’s New in Trauma and Critical Care Chet A Morrison, MD, FACS, FCCM Attending Trauma Surgeon Lancaster General Hospital Traumatic Injury: Still the Same Old Problem Plus ca change…. • From 2000 to 2010, the US population increased by 9.7% and the number of trauma deaths increased by 22.8%. • Trauma deaths and death rates deceased in individuals younger than 25 years but increased for those 25 years and older. • The largest increases in trauma deaths were in individuals in their fifth and sixth decades of life. Since 2000, the largest proportional increase (118%) in crude trauma deaths occurred in 54-year-olds. • Overall, in 2010, trauma was the leading cause of death in individuals 46 years and younger. Trauma remains the leading cause of years of life lost Rhee P et al Ann Surg 2014, 260(1): 13-21 Maybe This is Why Gunshot Wounds: Unrelenting Violence Ten Year Retrospective Look at GSW victims 6322 patients Increase in number of gunshots per patients and body cavity wounds Increase in Mortality Total Inpatient cost 115 Million 75% unreimbursed Livingston D et al J Trauma Acute Care Surg 2014 76(1): 2-11 Gunshot Wounds: Unrelenting Violence Livingston D et al J Trauma Acute Care Surg 2014 76(1): 2-11 Hemostatic Resuscitation: The Prospective, Observational, Multicenter, Major Trauma Transfusion (PROMMTT) Study •Objective: To relate in-hospital mortality to early transfusion of plasma and/or platelets and to time-varying plasma:red blood cell (RBC) and platelet:RBC ratios. •Prospective cohort study documenting the timing of transfusions during active resuscitation and patient outcomes. Data were analyzed using time dependent proportional hazards models. Holcomb JB Arch Surg. Published online October 15, 2012. doi:10.1001/2013.jamasurg.387 Hemostatic Resuscitation: The Prospective, Observational, Multicenter, Major Trauma Transfusion (PROMMTT) Study • Setting: Ten US level I trauma centers. • Patients: Adult trauma patients surviving for 30 minutes after admission who received a transfusion of at least 1 unit of RBCs within 6 hours of admission (n=1245, the original study group) and at least 3 total units (of RBCs, plasma, or platelets) within 24 hours (n=905, the analysis group). • Main Outcome Measure: In-hospital mortality. Holcomb JB Arch Surg. Published online October 15, 2012. doi:10.1001/2013.jamasurg.387 Hemostatic Resuscitation: The Prospective, Observational, Multicenter, Major Trauma Transfusion (PROMMTT) Study • Results: Plasma:RBC and platelet:RBC ratios were not constant during the first 24 hours (P.001 for both). • In a multivariable time-dependent Cox model, increased ratios of plasma:RBCs (adjusted hazard ratio=0.31; 95% CI, 0.16-0.58) and platelets:RBCs (adjusted hazard ratio=0.55; 95% CI, 0.31-0.98) were independently associated with decreased 6-hour mortality, when hemorrhagic death predominated. In the first 6 hours, patients with ratios less than 1:2 were 3 to 4 times more likely to die than patients with ratios of 1:1 or higher. • After 24 hours, plasma and platelet ratios were unassociated with mortality, when competing risks from nonhemorrhagic causes prevailed. Holcomb JB Arch Surg. Published online October 15, 2012. doi:10.1001/2013.jamasurg.387 Hemostatic Resuscitation: The Prospective, Observational, Multicenter, Major Trauma Transfusion (PROMMTT) Study •Conclusions: Higher plasma and platelet ratios early in resuscitation were associated with decreased mortality in patients who received transfusions of at least 3 units of blood products during the first 24 hours after admission. Among survivors at 24 hours, the subsequent risk of death by day 30 was not associated with either ratio Non constant ratios make this a confusing question! Holcomb JB Arch Surg. Published online October 15, 2012. doi:10.1001/2013.jamasurg.387 Hemostatic Resuscitation: The Prospective, Observational, Multicenter, Major Trauma Transfusion (PROMMTT) Study Holcomb JB Arch Surg. Published online October 15, 2012. doi:10.1001/2013.jamasurg.387 Hemostatic Resuscitation: The Prospective, Observational, Multicenter, Major Trauma Transfusion (PROMMTT) Study Holcomb JB Arch Surg. Published online October 15, 2012. doi:10.1001/2013.jamasurg.387 Hemostatic Resuscitation: The Prospective, Observational, Multicenter, Major Trauma Transfusion (PROMMTT) Study PROPPR: Pragmatic Randomized Optimal Platelet and Plasma Ratios • ObjectiveThis trial is sponsored by the National Heart Lung and Blood Institute and others. PROPPR is a multicenter, randomized trial which will compare different ratios of blood products given to trauma patients who are predicted to require massive transfusions (greater than 10 units of PRBCs within the first 24 hours). The patients who have been predicted to require a massive transfusion will receive blood products based on a 1:1:1 or 1:1:2 ratio of platelets, plasma and red blood cells. A total of 680 patients were enrolled into this study from 12 participating sites in the United States and Canada. In addition to evaluating the patient outcomes based on ratio of products, extensive lab analysis will be done to evaluate the influence of fluid resuscitation on traumatic induced coagulopathy. The PROPPR trial will be conduced under exception from informed consent. The trial began in August of 2012 and concluded enrollment on December 2, 2013. Data analysis is currently underway. http://clinicaltrials.gov/ct2/show/NCT01545232 A Paradigm Shift in Trauma Resuscitation: Evaluation of Evolving Massive Transfusion Practices • Objective To evaluate changes in the administration of fluids and blood products, hypothesizing that a reduction in crystalloid volume and a reduced red blood cell (RBC) to fresh frozen plasma (FFP) ratio over the last 7 years would correlate with better resuscitation outcomes. • Design Observational prospective cohort study. • Setting Urban level I trauma center. • Participants A total of 174 trauma patients receiving a massive transfusion (>10 units of RBCs in 24 hours) or requiring the activation of the institutional massive transfusion protocol from February 2005 to June 2011. Kutcher ME JAMA Surg. 2013;148(9):834-840. A Paradigm Shift in Trauma Resuscitation: Evaluation of Evolving Massive Transfusion Practices A, The mean combined numbers of red blood cells (RBCs), fresh frozen plasma (FFP), and pooled donor platelets given within 24 hours of admission, by year of study period, are shown. The bars represent the product breakdown (P = .03 by test for trend). TimeB, The median ratios of RBCs to FFP transfused within 24 hours of admission, by year of study period (P = .20 by test for trend), are shown. C, The median volumes of intravenous crystalloid administered within 24 hours of admission, by year of study period (P < .001 by test for trend), Kutcher ME JAMA Surg. 2013;148(9):834-840. A Paradigm Shift in Trauma Resuscitation: Evaluation of Evolving Massive Transfusion Practices Kaplan-Meier 72-hour survival plots based on the red blood cell (RBC) to fresh frozen plasma (FFP) ratio transfused within 24 hours of admission are shown for unadjusted survival (P < .001 determined by log-rank test) (A) and adjusted for age, Injury Severity Score, Glasgow Coma Scale score, and base deficit at admission using Cox proportional hazards regression (B). Kutcher ME JAMA Surg. 2013;148(9):834-840. TEG •Originally used in Cardiopulmonary bypass •May predict who will require transfusion •Platelet mapping may be useful •May decrease blood product use •May predict pulmonary embolism risk TEG Cotton, B J Trauma Acute Care Surg. 2012 72(6):1470-1477 TXA •Generic relatively cheap fibrinolysis inhibitor •Demonstrated ‘efficacy’ in CRASH-2 •Easy to administer •Issues with study •No benefit 3 hrs after injury TXA Valle EJ J Trauma Acute Care Surg 2014 76(1): 1373 From: Declining Case Fatality Rates for Severe Sepsis: Good Data Bring Good News With Ambiguous Implications JAMA. 2014;311(13):1295-1297. doi:10.1001/jama.2014.2639 Figure Legend: Potential Mechanisms of Decreasing Short-term Mortality Among Patients Across a Distribution of Illness Severity Date of download: 7/16/2014 Copyright © 2014 American Medical Association. All rights reserved. Sepsis Care: The ProCESS Trial Backgound •In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. Trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary. • The ProCESS Investigators. N Engl J Med 2014;370:1683-1693 Sepsis Care: The ProCESS Trial Method •In 31 emergency departments in the United States, patients with septic shock were randomly assigned to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. •The primary end point was 60-day in-hospital mortality; sequentially evaluation whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support. The ProCESS Investigators. N Engl J Med 2014;370:1683-1693 Sepsis Care: The ProCESS Trial The ProCESS Investigators. N Engl J Med 2014;370:1683-1693 Sepsis Care: The ProCESS Trial Results •1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. • •Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. •By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support. The ProCESS Investigators. N Engl J Med 2014;370:1683-1693 Sepsis Care: The ProCESS Trial Conclusion •The investigators concluded that in a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. ProCESS ClinicalTrials.gov number, NCT00510835.) The ProCESS Investigators. N Engl J Med 2014;370:1683-1693 Sepsis Care: The ProCESS Trial Outcomes. RESULTS The ProCESS Investigators. N Engl J Med 2014;370:16831693. Sepsis Care: The ProCESS Trial Cumulative Mortality. Survival The ProCESS Investigators. N Engl J Med 2014;370:1683-1693. Other Recent Attempts at Sepsis Therapy •HFOV -Found to be ineffective at one trial; increased mortality in another • Statins -Also not effective; no significant mortality decreases •CytoFab -CytoFab, a polyclonal anti–tumor necrosis factor antibody (ClinicalTrials.gov number, NCT01145560) Work halted, proposed trial canceled Prone Positioning in Severe ARDS Guerin et Al NEJM 2013 www.NEJM.org Cognitive Impairment as a Long Term Problem (Whisker Plot) Cognitive Impairment as a Function of Delirium Duration Nutritional Interventions for Critically Ill Patients, According to Data from Randomized, EnteralControlledENteralTrials. Feeding Summary Casaer MP, Van den Berghe G. N Engl J Med 2014;370:1227-1236. Comparison of Macronutrient Intake and Outcomes of Five Randomized, Controlled Trials Evaluating Nutrition during Critical Illness Trial of the Route of Early Nutritional Support in Critically Ill Adults Pragmatic, open, multicenter, parallel-group, randomized, controlled trial; 33 ICU in England participated Patients who were at least 18 years of age were eligible if they were expected to require nutritional support for at least 2 days, as determined by a clinician within 36 hours after an unplanned ICU admission that was expected to last at least 3 days. Could be fed either way Harvey SE et al. N Engl J Med 2014;371:1673-1684 Daily SOFA Score and Protein and Caloric Intake from Days 1 to 6. Harvey SE et al. N Engl J Med 2014;371:1673-1684. Daily SOFA Score and Protein and Caloric Intake from Days 1 to 6. The target nutritional value of 25 kcal per kilogram per day was NOT achieved for the majority of patients in the two study groups, although caloric intake was similar in the two groups. Harvey SE et al. N Engl J Med 2014;371:1673-1684. Nutrition: The EDEN trial • Designed to answer the question of trophic vs Full Feeds in ALI • Randomized, open-label,multicenter trial conducted from January 2, 2008, through April 12, 2011. • 1000 adults within 48 hours of developing acute lung injury requiring mechanical ventilation whose physicians intended to start enteral nutrition at 44 hospitals in the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network. • Participants were randomized to receive either trophic or full enteral feeding for the first 6 days. After day 6, the care of all patients who were still receiving mechanical ventilation was managed according to the full feeding protocol. • Main Outcome Measures Ventilator-free days to study day 28. Rice TW et al JAMA 2012;307:795-803 The EDEN trial: Results • Initial trophic feeding did not increase the number of ventilator-free days (14.9 [95% CI,13.9 to 15.8] vs 15.0 [95% CI, 14.1 to 15.9]; difference, −0.1 [95% CI, −1.4 to 1.2];P=.89) • 60-day mortality 23.2% vs 22.2% [95% P=.77) compared with full feeding. • No differences in infectious complications between the groups. • Despite receiving more prokinetic agents, the full-feeding group experienced more vomiting (2.2% vs 1.7% of patient feeding days; P=.05), elevated gastric residual volumes (4.9% vs 2.2% of feeding days; P.001), and constipation (3.1% vs 2.1%of feeding days; P=.003). • Meanplasma glucose values and average hourly insulin administration were both higher in the full-feeding group over the first 6 days. Rice TW et al JAMA 2012;307:795-803 The EDEN trial: Results The EDEN trial: Results The EDEN trial: Results Recommendations for Clinical Nutritional Practice in the ICU and for Future Research. Recommendations Casaer MP, Van den Berghe G. N Engl J Med 2014;370:1227-1236. ICP Monitoring: On Trial • Intracranial-pressure monitoring is considered the standard of care for severe traumatic brain injury. Efficacy of treatment based on monitoring in improving the outcome has not been rigorously assessed. • Multicenter, controlled trial in which 324 patients 13 years of age or older randomly assigned to one of two specific protocols: guidelinesbased management in which a protocol for monitoring intraparenchymal intracranial pressure was used or a protocol in which treatment was based on imaging and clinical examination. • The primary outcome was a composite of survival time,impaired consciousness, and functional status at 3 months and 6 months and neuropsychological status at 6 months; Chesnut RA N Engl J Med 2012; 367:2471-2481 ICP Monitoring: On Trial • There was no significant between-group difference in the primary outcome, a composite measure based on percentile performance across 21 measures of functional and cognitive status (score, 56 in the pressure-monitoring group vs. 53 in the imaging–clinical examination group; P = 0.49). • Six-month mortality was 39% in the pressure-monitoring group and 41% in the imaging–clinical examination group • The median length of stay in the ICU was similar in the two groups (12 days in the pressure-monitoring group and 9 days in the imaging–clinical examination group; P = 0.25) • The number of days of brain-specific treatments (e.g.administration of hyperosmolar fluids and the use of hyperventilation) in the ICU was higher in the imaging–clinical examination group than in the pressure-monitoring group (4.8 vs. 3.4, P = 0.002). • The distribution of serious adverse events was similar in the two groups. Chesnut RA N Engl J Med 2012; 367:2471-2481 ICP Monitoring: On Trial Conclusions •For patients with severe traumatic brain injury, care focused on maintaining monitored intracranial pressure at 20 mm Hg or less was not shown to be superior to care based on imaging and clinical examination •So wither ICP monitors? •Still part of BTF recommendations CDC New Definition VAE •Multiple Stakeholders (none of them surgeons) •Tiered System •Variety of Clinical, radiologic and microbiologic criteria •Concerns raised about under/overdiagnosis and ‘gaming New CDC Definition of VAP New CDC Definition of VAP New CDC Definition of VAP How We are Denied Money Rib Fractures Rib Fracture Fixation: Prospective Trial •Traumatic flail chest injury •A prospective randomized study compared operative fixation of fractured ribs in the flail segment with current best practice mechanical ventilator management. In-hospital data, 3month follow-up review, spirometry and CT, and 6-month quality of life (Short Form-36) questionnaire were collected. •Patients in the operative fixation group had significantly shorter ICU stay (hours) postrandomization (285 hours [range 191 to 319 hours] for the surgical group vs 359 hours [range 270 to 581 hours] for the conservative group; p = 0.03) and lesser requirement for noninvasive ventilation after extubation (3 hours [range 0 to 25 hours] in the surgical group vs 50 hours [range 17 to 102 hours] in the conservative group; p = 0.01). No differences in spirometry at 3 months or quality of life at 6 months were noted. •Operative fixation of fractured ribs reduces ventilation requirement and intensive care stay in a cohort of multitrauma patients with severe flail chest injury. Marasco S J AM Coll Surg 216 (5) 2013 Rib Fracture Fixation: Prospective Trial Marasco S J AM Coll Surg 216 (5) 2013 Rib Fracture Fixation: Prospective Trial Marasco S J AM Coll Surg 216 (5) 2013 RIB Fracture Fixation: Cost Analysis Costs of Procedures and Diagnoses Based on 2010 National Medicare Reimbursement Procedure/diagnosis ORIF Flail chest Wound infection Sepsis Bleeding DVT PE Intubation<96 h Intubation>96 h Tracheostomy with intubation <96 h Tracheostomy with intubation>96 h VAP Cost, $ 3,961.16 484.02 4,894.69 5,627.73 4,894.69 3,281.29 5,390.61 11,279.68 26,123.17 11,661.63 26,505.12 3,679.84 Bhatnagar A - J Am Coll Surg - 01-AUG-2012; 215(2): 201-5 RIB Fracture Fixation: Cost Analysis • Mean cost effectiveness of open reduction and internal fixation for flail chest (ORIFFC) vs standard of care (SOC). Bhatnagar A - J Am Coll Surg - 01-AUG-2012; 215(2): 201-5 The Future: Suspended Animation Killing a Patient to Save His Life The Future: Suspended Animation Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR-CAT) • Systematic preclinical studies at the Safar Center for Resuscitation Research under the direction of Drs. Safar, Sam Tisherman, and Pat Kochanek demonstrated the feasibility of inducing profound hypothermia (50ºF or 10ºC) to provide a prolonged period of cardiac arrest after exsanguinating hemorrhage. • Dr. Tisherman is now leading the Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR-CAT) Study. This study is a feasibility and safety study designed to see if hypothermia is beneficial in this setting. In EPR, body temperature is lowered to about 50ºF (10ºC) by administering a large volume of cold fluid through a cannula placed into the aorta. A heart-lung bypass machine would be used to restore blood circulation and oxygenation as part of the resuscitation process. The study will be conducted at the University of Pittsburgh and the University of Maryland. • Estimated Completion by Dec 2016 Under Fire: Gun Violence is not just an Urban Problem • C. Morrison1, K. Bupp1, B. Gross1, K. Rittenhouse1, F. Rogers1 ; 1Lancaster General Hospital, Trauma, Lancaster, PA, USA •Introduction: Gun violence continues to be a source of trauma patient morbidity and mortality annually in U.S. communities. Recent research suggests increasing gunshot violence severity in urban centers. We sought to characterize gun violence in the combined suburban and rural county of Lancaster, PA, to compare it to gun violence results obtained in urban areas. Under Fire: Gun Violence is not just an Urban Problem Methods: In a Pennsylvania-verified, level II trauma center, treated gunshot wounds (GSW) from January 2000 to December 2013 were queried from the trauma registry. BB/pellet GSWs were excluded. Data collected included mortality, ISS, and number of GSW per patient. Cost data was obtained for patients from 2004-2013, and costs were calculated using cost-charge modifiers. A binary logistic regression was performed to assess mortality over time. Linear trend tests assessed the change in percent of patients with 3 or more GSWs, with ISS≥15 and ISS≥25 over the 14-year study period. Significance was defined as p<0.05. Under Fire: Gun Violence is not just an Urban Problem Results: A total of 478 patients met inclusion criteria. Of these patients, 83.3% sustained interpersonally-inflicted GSWs, while the remaining 16.7% sustained selfinflicted GSWs. The population was 62% white, 35% black, and 3% other. Risk-adjusted mortality (for age, ISS) showed no significant change in mortality over time (p=0.999). Linear trend tests revealed no significant changes in percent of patients with 3 or more GSWs (p=0.693), with ISS≥15 (p=0.546), or with ISS≥25 (p=0.342) over time. No significant change in cost per case was found (p=0.380), however percent reimbursement significantly increased (p=0.009). Under Fire: Gun Violence is not just an Urban Problem Conclusion: Even the fairly suburban and rural communities of Lancaster County, PA are not sheltered from the problem of gun violence, although the rate seems to be stable in a non-urban environment. Despite advances in pre-hospital and hospital care, including damage control techniques, the mortality from GSW has not changed. Future efforts to improve the outcome for GSW Must primarily include preventative efforts. 71 Summary Thoughts: Where are we at? •Trauma Still qualifies as an unrelenting problem •Liberal use of blood and factors in resuscitation •We continue with a long list of sepsis interventions that are of limited use •There are opportunities to improve quality of life in the Critical Patient Thank You for Your Attention