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Kyle Gunnerson, MD, FCCM
Chief, Division of Emergency Critical Care
Director, Emergency Critical Care Center
Department of Emergency Medicine
University of Michigan Health System
 Federal Grant Funding
 5 U01 HL123031-07: Clinical Centers (CC) for the NHLBI Prevention and Early Treatment
of Acute Lung Injury(PETAL) Clinical Trials Network. Co-I with effort
 NHLBI 1R34HL130738-01A1: Extracorporeal CPR for Refractory Out-of-Hospital Cardiac
Arrest (EROCA) Trial Planning Grant. Co-I with effort
 1 U24 NS100680-01: NHLBI/NINDS: Network for Emergency Care Clinical Trials:
Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network
Clinical Center. Spoke PI
 DOD: BA150235 - A Multimodal Integrative Platform for Continuous Monitoring and
Decision Support during Postoperative Care in Cardiac Patients. Co-I with effort
 Institutional Funding
 University of Michigan Health System - Peking University Health Science Center Joint
Institute – Development of ED-ICU severity scoring system
 ED-ECMO team simulation – University of Michigan Simulation Center Grant
 Committees
 Society of Critical Care Medicine – Council Member (EM section, 2016-current)
Grand opening February 16, 2015
• Expand clinical research infrastructure in
critical care in synergy with the newly
established Michigan Center for Integrative
Research in Critical Care (MCIRCC)
• Provide a critical care research infrastructure
to study the hyper-acute phase of critical
illness
• Partner with current and emerging critical
illness research pipelines (NETT, Trauma/Burn
Center)
TBI
•Facilitate collaboration with
inpatient critical care providers in
areas of patient care, education,
and research.
•UMHS established as Center of
Excellence for regionalized
Emergency Critical Care and Critical
Care in general.
TBI
Emergency Critical
Care Advisory
Committee
SICU/TBICU
Dr. Napolitano
NICU
Dr. Jacobs
Med ICU
Dr. Hyzy
CVICU
Dr. Engoren
CICU
Dr. Gurm
Clinical guidelines
and pathways
Next
step
Clinical
Trials
 Average 7 patients per day
 Median EC3 LOS ICU admit = 7.2 hr
 Median EC3 LOS Non-ICU admit = 12 hr
BiPap/Intubation/Vent 595 11.5%
DKA 276 5.3%
End of Life 61 1.2%
GI Bleed 421 8.1%
Post Cardiac Arrest 84 1.6%
Sepsis 794 15.4%
Shortness of Breath 514 9.9%
Status Epilepticus 57 1.1%
Subarachnoid Hemorrhage 133 2.6%
Undifferentiated 2,546 49.2%
Unknown 391 7.6%
EC3 Pathway
Multiple per patient possible Count %
 Industry Sponsored
 Euphrates – Sepsis
 Euphoria – Sepsis
 BMS – Sepsis
 Dabigatran reversal – anticoagulation
 Investigator Initiated
 DKA
 PReDICT – Severity scoring model
 POC Biomarker panel
 US to evaluate lung function in respiratory failure
 Non-invasive monitoring of critically ill and injured
 Federally Funded
 NIH
 DOD
 NHLBI Clinical Trials Network of 12 clinical centers and one CCC
 2014 - 2021
 Develop new innovative approaches to prevent and improve the
outcomes of patients who are at risk for ARDS including patients in shock
or respiratory failure from sepsis.
 Build on findings from the ARDS Network to develop earlier treatments
for patients with ARDS
 Develop collaborative working relationships between pulmonary/critical
care and emergency department disciplines
 Establish a collection of biospecimens to aid both network investigators
and the greater research community in studying the disease process in
critically ill patients and finding better ways to treat them.
 Seek input from the international emergency and critical care community
 ROSE - Reevaluation Of Systemic Early neuromuscular blockade
 Bob Hyzy, MD – Pulmonary/Critical Care
 Pauline Park, MD – Acute Care Surgery/Critical Care
 Kyle Gunnerson, MD – Emergency Medicine/Critical Care
 Kristine Nelson, RN – Study Coordinator
 Acute Critical Care, Surgery, and Transplant CTSU study
 Spokes
 Henry Ford Hospital – Bruno DiGiovine, MD, Pulm/CC and Manny Rivers, MD EM/CC
 Indiana University – Mark Williams, MD Pulm/CC
 Current enrollment
 39 enrolled since Nov. 2016
 UM top half enrollment in last quarter
 PRIMROSE
 Ancillary study, opened January 2017, 3 subjects enrolled to date, evaluating the
effects of NMB on the development of weakness in ARDS patients
 PETE-ROSE
 Ancillary study, not yet open, a qualitative study in which clinicians caring for ROSE
patients will be interviewed to understand provider perceptions of neuromuscular
blockade and develop a framework to speed implementation should the study be
positive
 REDROSE
 Ancillary study, not yet open, This investigator-initiated ancillary study will measure
breath stacking dyssynchrony (BSD) and true tidal volume (VT) delivered in a
subgroup of patients enrolled in the NHLBI PETAL Network ROSE Trial.
 VIOLET (Next trial)
 Large dose vitamin D to prevent ARDS, not open to enrollment yet, we will be using
our central lab for vitamin D testing, other sites will be using the Qualigen device
 CLOVERS
 Early Fluid vs Vasopressor for hypotension – Discussion phase
 Network for Emergency
Care Clinical Trials:
Strategies to Innovate
EmeRgENcy Care Clinical
Trials Network (SIREN) –
10 Sites, 1 CCC, 1 DCC.
NHLBI/NINDS
SIREN will enable the
conduct of high-quality,
multi-site clinical trials to
improve the outcomes for
patients with neurologic,
cardiac, respiratory, and
hematologic, and trauma
emergency events.
 PI – Bob Bartlett, MD and Bob Neumar, MD, PhD
 NHLBI
 Collaboration:
 EM, Cardiac Surgery, Neurology, Cardiology, ECMO, CVICU, Anesthesiology,
Surgery, HVA, AA Fire Dept.
 Refractory OHCA
 EFIC
 ECMO center vs Standard
 Goal Directed CPR
 EM directed V-A ECMO cannulation and management for first 24 hr
 Start date May 1, 2017
 The Massey Family Foundation Emergency Critical Care Center
 Provides excellent patient-centered acute critical care
 Provides a rich educational opportunity
 Infrastructure for clinical research
 Investigator initiated, industry
 Federal
 EC3 provides the Emergency Department and Michigan Medicine an
invaluable resource for conducting acute critical care clinical research

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Acute Critical Care Research: Massey Family Foundation Emergency Critical Care Center by Kyle Gunnerson

  • 1. Kyle Gunnerson, MD, FCCM Chief, Division of Emergency Critical Care Director, Emergency Critical Care Center Department of Emergency Medicine University of Michigan Health System
  • 2.  Federal Grant Funding  5 U01 HL123031-07: Clinical Centers (CC) for the NHLBI Prevention and Early Treatment of Acute Lung Injury(PETAL) Clinical Trials Network. Co-I with effort  NHLBI 1R34HL130738-01A1: Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest (EROCA) Trial Planning Grant. Co-I with effort  1 U24 NS100680-01: NHLBI/NINDS: Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network Clinical Center. Spoke PI  DOD: BA150235 - A Multimodal Integrative Platform for Continuous Monitoring and Decision Support during Postoperative Care in Cardiac Patients. Co-I with effort  Institutional Funding  University of Michigan Health System - Peking University Health Science Center Joint Institute – Development of ED-ICU severity scoring system  ED-ECMO team simulation – University of Michigan Simulation Center Grant  Committees  Society of Critical Care Medicine – Council Member (EM section, 2016-current)
  • 4. • Expand clinical research infrastructure in critical care in synergy with the newly established Michigan Center for Integrative Research in Critical Care (MCIRCC) • Provide a critical care research infrastructure to study the hyper-acute phase of critical illness • Partner with current and emerging critical illness research pipelines (NETT, Trauma/Burn Center) TBI
  • 5. •Facilitate collaboration with inpatient critical care providers in areas of patient care, education, and research. •UMHS established as Center of Excellence for regionalized Emergency Critical Care and Critical Care in general. TBI
  • 6. Emergency Critical Care Advisory Committee SICU/TBICU Dr. Napolitano NICU Dr. Jacobs Med ICU Dr. Hyzy CVICU Dr. Engoren CICU Dr. Gurm Clinical guidelines and pathways Next step Clinical Trials
  • 7.  Average 7 patients per day  Median EC3 LOS ICU admit = 7.2 hr  Median EC3 LOS Non-ICU admit = 12 hr BiPap/Intubation/Vent 595 11.5% DKA 276 5.3% End of Life 61 1.2% GI Bleed 421 8.1% Post Cardiac Arrest 84 1.6% Sepsis 794 15.4% Shortness of Breath 514 9.9% Status Epilepticus 57 1.1% Subarachnoid Hemorrhage 133 2.6% Undifferentiated 2,546 49.2% Unknown 391 7.6% EC3 Pathway Multiple per patient possible Count %
  • 8.  Industry Sponsored  Euphrates – Sepsis  Euphoria – Sepsis  BMS – Sepsis  Dabigatran reversal – anticoagulation  Investigator Initiated  DKA  PReDICT – Severity scoring model  POC Biomarker panel  US to evaluate lung function in respiratory failure  Non-invasive monitoring of critically ill and injured  Federally Funded  NIH  DOD
  • 9.  NHLBI Clinical Trials Network of 12 clinical centers and one CCC  2014 - 2021
  • 10.  Develop new innovative approaches to prevent and improve the outcomes of patients who are at risk for ARDS including patients in shock or respiratory failure from sepsis.  Build on findings from the ARDS Network to develop earlier treatments for patients with ARDS  Develop collaborative working relationships between pulmonary/critical care and emergency department disciplines  Establish a collection of biospecimens to aid both network investigators and the greater research community in studying the disease process in critically ill patients and finding better ways to treat them.  Seek input from the international emergency and critical care community
  • 11.  ROSE - Reevaluation Of Systemic Early neuromuscular blockade
  • 12.  Bob Hyzy, MD – Pulmonary/Critical Care  Pauline Park, MD – Acute Care Surgery/Critical Care  Kyle Gunnerson, MD – Emergency Medicine/Critical Care  Kristine Nelson, RN – Study Coordinator  Acute Critical Care, Surgery, and Transplant CTSU study  Spokes  Henry Ford Hospital – Bruno DiGiovine, MD, Pulm/CC and Manny Rivers, MD EM/CC  Indiana University – Mark Williams, MD Pulm/CC  Current enrollment  39 enrolled since Nov. 2016  UM top half enrollment in last quarter
  • 13.  PRIMROSE  Ancillary study, opened January 2017, 3 subjects enrolled to date, evaluating the effects of NMB on the development of weakness in ARDS patients  PETE-ROSE  Ancillary study, not yet open, a qualitative study in which clinicians caring for ROSE patients will be interviewed to understand provider perceptions of neuromuscular blockade and develop a framework to speed implementation should the study be positive  REDROSE  Ancillary study, not yet open, This investigator-initiated ancillary study will measure breath stacking dyssynchrony (BSD) and true tidal volume (VT) delivered in a subgroup of patients enrolled in the NHLBI PETAL Network ROSE Trial.  VIOLET (Next trial)  Large dose vitamin D to prevent ARDS, not open to enrollment yet, we will be using our central lab for vitamin D testing, other sites will be using the Qualigen device  CLOVERS  Early Fluid vs Vasopressor for hypotension – Discussion phase
  • 14.  Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) – 10 Sites, 1 CCC, 1 DCC. NHLBI/NINDS SIREN will enable the conduct of high-quality, multi-site clinical trials to improve the outcomes for patients with neurologic, cardiac, respiratory, and hematologic, and trauma emergency events.
  • 15.  PI – Bob Bartlett, MD and Bob Neumar, MD, PhD  NHLBI  Collaboration:  EM, Cardiac Surgery, Neurology, Cardiology, ECMO, CVICU, Anesthesiology, Surgery, HVA, AA Fire Dept.  Refractory OHCA  EFIC  ECMO center vs Standard  Goal Directed CPR  EM directed V-A ECMO cannulation and management for first 24 hr  Start date May 1, 2017
  • 16.  The Massey Family Foundation Emergency Critical Care Center  Provides excellent patient-centered acute critical care  Provides a rich educational opportunity  Infrastructure for clinical research  Investigator initiated, industry  Federal  EC3 provides the Emergency Department and Michigan Medicine an invaluable resource for conducting acute critical care clinical research

Editor's Notes

  1. 1