Massachusetts General Hospital

Our Mission

We aim to:

• Establish an inclusive, nationwide network of experts to review published data, establish national priorities, vet hypotheses, write clinical protocols, and generate pilot data
• Promote interactions and synergy across established programs, both academic and non-academic, to improve the robustness (power) of clinical trials and test hypotheses in a US population
• Provide a venue to discuss education and training in the science of clinical trial design, conduct, analysis, and reporting for critically ill or injured patients
• Insure patient protection and privacy by addressing the ethical, legal, and social implications (ELSI) of research in the specialized circumstance of critical illness or injury

Organizational Approach

Starting a US Critical Illness and Injury Trials Group (USCIITG) will require overcoming a number of organizational and logistical hurdles, including:

• lack of coordinated university and hospital support for critical illness and injury research, which is typically dispersed across multiple departments
• partitioning of NIH funding for critical illness and injury studies across a large number of institutes and centers
• large geographic distances separating major critical illness and injury research centers in the US

To address these challenges, the organizational approach emphasizes frequent, face-to-face meetings that are aimed at generating fundable, high-impact clinical research proposals. These proposals are expected to span the patient age and time care continuums (pre-hospital to recovery). To contact us, please e-mail USCIITGroup@partners.org.

Organizing Committee

The Organizing Committee provides general oversight for the USCIIT Group serving its dual missions. This includes Steering Committee membership and strategic partnerships with other federal and private agencies.

• Satish (Sats) Bhagwanjee, MB, ChB Associate Director, Outreach, of the USCIIT Group and Professor, Anesthesiology and Pain Medicine, University of Washington Medical Center
• Charles Cairns, MD, FACEP, FAHA Associate Director of the USCIIT Group and Professor & Chair, Emergency Medicine, University of North Carolina at Chapel Hill
• J. Perren Cobb, MD Director of the USCIITG Group, Director of the Mass General Critical Care Center, and Vice-Chair of the Division of Critical Care in the Department of Anesthesia, Critical Care and Pain Medicine
• Robert Danner, MD Senior Scientist and Head, Infectious Disease Section, Critical Care Medicine Department (NIH)
• Basil A. Eldadah, MD, PhD Program Officer, Geriatrics Branch, Division of Geriatrics and Clinical Gerontology of the NIA (NIH)
• Andrea Harabin, PhD Program Director, Acute Lung Injury and Critical Care Medicine in the Division of Lung Diseases of NHLBI (NIH)
• Ramona Hicks, PhD Program Director in the Repair and Plasticity Cluster of the Division of Extramural Research at NINDS (NIH)
• Peter Munson, PhD Chief of the Mathematical and Statistical Computing Laboratory of the Center for Information Technology (CIT, NIH)
• Carol Nicholson, MD Program Director of the Pediatric Critical Care & Rehabilitation Program (NICHD) and the Project Scientist for the Collaborative Pediatric Critical Care Research Network of the NICHD (NIH)
• Mary Purucker, MD, PhD Medical Officer/Program Officer, Division of Clinical Research Resources of the NCRR (NIH)
• Lewis Rubinson, MD, PhD, FCCP Commander, USPHS, Deputy Chief Medical Officer, National Disaster Medical System, HHS/ASPR/OPEO
• Scott Somers, PhD is the assigned NIGMS Project Scientist (NIH)
• Anthony Suffredini, MD Senior Scientist and Head, Critical Care Research Section, Critical Care Medicine Department (NIH)

Steering Committee

The Steering Committee is responsible for the scientific content of the USCIITG meetings and organizing the meeting product into deliverables and timelines. It provides general oversight of the meetings, identifies specific milestones, and interacts with other networks and professional organizations. Membership rotates every three years. The 2011-2013 membership is:

• Tom Ahrens, PhD, RN, CCNS, FAAN Research Scientist, Barnes-Jewish Hospital
• James M. Blum, MD Assistant Professor of Anethesiology, Director, Critical Care Research, Associate Director, Critical Care Fellowship, University of Michigan Medical Center
• Karyn L. Butler, MD Director, Surgical Critical Care Center, Hartford Hospital
• William G. Barsan, MD Professor and Chair, Department of Emergency Medicine, University of Michigan, Principal Investigator, Neurological Emergencies Treatment Trials (NETT) Clinical Coordinating Center
• Lance B. Becker, MD Professor of Emergency Medicine, Director of the Center for Resuscitation Science in the Department of Emergency Medicine, University of Pennsylvania Health System
• Bruce A. Cairns, MD, FACS Director, North Carolina Jaycee Burn Center, John Stackhouse Distinguished Associate Professor of Surgery, The University of North Carolina at Chapel Hill, UNC School of Medicine
• J. Michael Dean, MD, MBA H.A. and Edna Benning Presidential Professor of Pediatrics, Adjunct Professor, Biomedical Informatics, Vice Chairman, Department of Pediatrics, Chief, Division of Pediatric Critical Care Medicine, University of Utah School of Medicine 
• Brian Erstad, PharmD Professor, Pharmacy Practice & Science, University of Arizona College of Pharmacy 
• Ognjen Gajic, MD Professor of Medicine, Mayo Clinic Pulmonary and Critical Care
• Nina T. Gentile, MD Professor, Emergency Medicine, Temple University
• Michelle Ng Gong, MD, MS Director of Critical Care Research, Associate Professor in Medicine, Montefiore Medical Center, Albert Einstein College of Medicine 
• Greg S. Martin, MD, MSc Associate Professor of Medicine and Associate Director, Critical Care Division of Pulmonary, Allergy and Critical Care, Emory University School of Medicine, Chief of Pulmonary and Director of Medical and Coronary Intensive Care, Grady Memorial Hospital 
• Anthony Martinez, MD Director, Adult Intensive Care Unit, St. Agnes Hospital Baltimore
• Lena Napolitano, MD Division Chief, Acute Care Surgery, University of Michigan Health Systems
• Graham Nichol, MD, MPH, FRCP(C), FACP, FAHA Professor of Medicine, Director and Endowed Chair, Medic One Foundation, Harborview Center for Prehospital Emergency Care, Medical Director, University of Washington Clinical Trials Center
• Polly E. Parsons, MD E. L. Amidon Professor, Chair, Department of Medicine, Director, Pulmonary and Critical Care Unit, University of Vermont College of Medicine 
• Jonathan E. Sevransky, MD, MHS Medical Director, JHBMC MICU, Assistant Professor of Medicine, Johns Hopkins University School of Medicine 
• Daniel S. Talmor, MD, MPH Vice Chair for Critical Care, Department of Anesthesia, Critical Care & Pain Medicine, Beth Israel Deaconess Medical Center, Associate Professor of Anaesthesia, Harvard Medical School 
• B. Taylor Thompson. MD Professor of Medicine, Harvard Medical School, Director, Medical Intensive Care at the Massachusetts General Hospital
• Jeffrey S. Upperman, MD Associate Professor of Surgery at the Keck School of Medicine, University of Southern California, and Director, Trauma Program, PDRTC, Children's Hospital Los Angeles 
• Hector Wong, MD Professor of Pediatrics, University of Cincinnati, and Chief, Critical Care Medicine, Cincinnati Children's Hospital Medical Center 
• David W. Wright, MD Assistant Professor of Emergency Medicine and Director, Emergency Neurosciences at Emory University School of Medicine
• Donald M. Yealy, MD Professor and Chair of Emergency Medicine, University of Pittsburgh School of Medicine and the University of Pittsburgh Medical Center

Representatives

• Anderson, III, Harry L. St. Joseph Mercy Ann Arbor - Trauma, Critical Care & Emergency Surgery
• Angus, Derek University of Pittsburgh - Critical Care Medicine
• Asensio, Juan University of Miami Medical School - Trauma & Surgical Critical Care
• Bird, Steven University of Massachusetts Medical School - Emergency Medicine
• Bulger, Eileen University of Washington, Seattle - Trauma, Critical Care and Acute Surgical Emergencies
• Burke, Peter Boston Medical Center - Trauma Surgery & Critical Care
• Chang, Steven Y. University of Medicine and Dentistry of New Jersey - Pulmonary & Critical Care Medicine
• Checchia, Paul A. Washington University-St. Louis - Pediatrics
• Christie, Jason D. University of Pennsylvania Health System - Pulmonary & Critical Care
• Cohen, Mitchell University of California, San Francisco - Trauma Critical Care
• Deem, Steven University of Washington, Seattle - Critical Care Medicine
• Djurkovic, Svetolik Geisinger Medical Center - Critical Care & Infectious Disease
• Engel, Charles Walter Reed Army Medical Center - Clinical Epidemiology
• Federspiel, Nancy Stanford University - Genomics
• Frendl, George Brigham and Women's Hospital/Harvard Medical School - Anesthesia & Critical Care
• Gaspari, Romolo,University of Massachusetts - Emergency Medicine
• Goldfarb, Roy D. Robert Wood Johnson Medical School - Physiology, Pharmacology, Cardiology & Critical Care Medicine
• Gropper, Michael A. Moffitt/UCSF - Anesthesia & Perioperative Care & Critical Care Medicine
• Halpern, Scott University of Pennsylvania - Pulmonary, Critical Care Medicine & Bioethics
• Hassan, Zubair University of Kansas - Critical Care Medicine
• Herr, Daniel University of Maryland - Cardiac Surgery, Lung and Heart Transplant
• Hoyt, David American College of Surgeons
• Jones, Alan Carolinas Medical Center, Charlotte, NC - Emergency Medicine
• Katz, Jason N. University of North Carolina School of Medicine - Cardiology & Critical Care Medicine
• Lederer, James A. Brigham and Women's Hospital/Harvard Medical School - Surgical Research
• Lipshutz, Angela Stanford University - Department of Medicine
• Mazer, Mark East Carolina University
• Meduri, G. Umberto Memphis VA Medical Center - Pulmonary, Critical Care & Sleep Medicine
• Meert, Kathleen Wayne State University, Detroit - Pediatrics
• Moine, Pierre University of Colorado Health Sciences Center - Anesthesia & Critical Care
• Morris, John Vanderbilt University - Trauma & Acute Care Surgery, Biomedical Informatics
• Morris, Peter Wake Forest Baptist Health - Pulmonary & Critical Care
• Munford, Robert S. UT Southwestern Medical Center - Infectious Diseases & Microbiology
• Namath, Allen Santa Clara Valley Medical Center - Pulmonary & Critical Care Medicine
• O'Brien, Jr., James M. Ohio State University Medical Center - Pulmonary, Allergy, Critical Care & Sleep Medicine
• Park, Pauline K. University of Michigan - Surgery, Trauma & Critical Care Medicine
• Patterson, Andrew Stanford University - Anesthesia & Critical Care
• Pittet, Jean-Francois University of California, San Francisco - Anesthesia & Critical Care Medicine
• Randolph, Adrienne Children's Hospital, Boston - Critical Care
• Riker, Richard Maine Medical Center, Portland - Pulmonary & Critical Care Medicine
• Rogers, Jr., Selwyn O. Brigham and Women's Hospital - Surgical Critical Care
• Sabella, Joseph Children's Medical Center, Dallas - Pediatrics, Trauma Research & Intensive Care
• Severance, Harry University of Tenneseee College of Medicine/Erlanger Health Systems - Emergency Medicine
• Sharma, Pushpa Uniformed Services University, Bethesda - Molecular Biology & Resuscitation Physiology
• Shelton, Ann University of Missouri, St. Louis - Nursing
• Stapleton, Renee D. University of Vermont - Pulmonary & Critical Care
• Taylor, Michael Fairview Hospital, Cleveland - Trauma & Critical Care
• Trzeciak, Stephen Cooper University Hospital, Camden, NJ - Critical Care & Emergency Medicine
• Weiner, Debra Children's Hospital, Boston - Pediatric Emergency Medicine
• Williamson, Peter University of Illinois-Chicago - Medicine, Pathology, Microbiology & Immunology
• Wiener-Kronish, Jeanine Chief of Anesthesia, Critical Care & Pain Medicine, Massachusetts General Hospital
• Wischmeyer, Paul University of Colorado Health Sciences Center - Anesthesia & Critical Care
• Wong, Jim Stanford University - Cardiac Anesthesia
• Woolard, Robert Texas Tech University Health Sciences Center - Emergency Medicine
• Young, Michael P. Wake Forest Baptist Health Pulmonary & Critical Care
• Yoza, Barbara Wake Forest Baptist Health - Sepsis

One of the missions of the USCIIT Group is fostering investigator-initiated clinical trials. To this end, a mechanism was established to solicit clinical proposals with the goal of supporting a number of Clinical Projects annually (see the "Clinical Proposals" tab for additional details). The success of these efforts depends upon a cooperative model of information exchange. The approach is inclusive and aims to learn from all those who advocate for the critically ill or injured. Hypotheses will be tested by multidisciplinary “teams” that openly solicit input and encourage collaboration among investigators with similar ideas across institutions. As many of these ideas will be novel and exciting, there is an inherent risk in sharing them. Thus, the USCIIT Group Code-of-Conduct relies on an implicit pact based on an honor system, wherein attendees are expected to:

• Respect the intellectual property presented and the previous commitments made by presenters and discussants
• Disclose competing interests or obligations that may conflict with new or existing Projects
• Refrain from using or sharing privileged information without the consent of the Organizing Committee and the Project Director(s)

At the inaugural USCIIT Group meeting in November 2008, 18 clinical projects were presented and discussed:

1. Estrogen and flutamide as adjuncts for the treatment of trauma
   Irshad Chaudry, PhD
   University of Alabama at Birmingham
2. Peri-operative Use of MethylPrednisolone (PUMP) study. Effect of Peri-operative methylprednisolone on outcome from cardiopulmonary bypass in children undergoing surgery for congenital heart disease
   Paul Checchia, MD
   Washington University in St. Louis
3. Development of a leukocyte gene expression profiling diagnostic test to predict multi-organ dysfunction after heart failure surgery
   Mario Deng, MD
   Columbia University
4. Controlled study comparing protocol directed tracheostomy decision making with usual care
   Bradley Freeman, MD
   Washington University in St. Louis
5. Identifying patients at risk of acute respiratory distress syndrome (ARDS) in the emergency room: external validation of an ARDS prediction model
   Ognjen Gajic, MD
   Mayo Clinic
6. Disordered sleep, memory and behavior after moderate to severe Traumatic Brain Injury (TBI): Developing a paradigm for treatment
   Michael Makley, MD
   University of Maryland
7. Pediatric Trauma Applied Research Network
   Randall Burd, MD, PhD
   Children's National Medical Center
8. Design of a diagnostic tool to predict adverse outcomes in critically ill patients with alcohol and other drug use disorders
   Marjolien de Wit, MD
   Virginia Commonwealth University
9. Validation of Early Bio-Signatures (Biomarkers) for Acute Kidney Injury in Critical Illness and Injury: Creating the Critical Illness and Injury Acute Kidney Injury Collaborative
   Gyorgy Frendl, MD, PhD
   Brigham and Women's Hospital
10. Impact of Dashboards and Checklists on Best Practice Compliance in Critical Care
    Henry Mann, PharmD
    University of Minnesota
11. Validation of a replicable (computerized) protocol for sedation in the ICU
    Russell Miller, MD, MPH
    Intermountain Medical Center
12. Testing the impact of replicable clinical trial methods in critical care research
    Alan Morris, MD
    Intermountain Medical Center
13. A prospective, randomized controlled clinical trial of the doseresponse effects of normal saline or lactated Ringer's solution on intraoperative metabolic acid-base status
    Edward Omron, MD, MPH
    Ingham Regional Medical Center
14. Phase I diagnostic trial for pathogen responsiveness after severe trauma using a bedside tolllike receptor (TLR) whole blood stimulation assay, gene expression analysis, and genotypes in 5 clinical centers
    Marion Schneider, MD
    University Ulm
15. Critical Illness Outcomes Study (CIOS)
    Jonathan Sevransky, MD, MHS
    Johns Hopkins University
16. Genomic Predictors of Outcome in candidemia
    Peter Williamson, MD
    University of Illinois at Chicago
17. A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients: The TOP UP Trial
    Paul Wischmeyer, MD
    University of Colorado
18. Pseudoaneurysm Embolization After Blunt Splenic Injury Trial
    Ben Zarzaur, MD, MPH
    University of Tennessee
19. PALISI Influenza Study
    Adrienne Rudolph, MD, MSC

2009 Clinical Proposals

1. Biomarkers of Lung Injury with Low Tidal Volume Ventilation Compared with Airway Pressure Release Ventilation
   Suresh Agarwal, MD
   Boston University School of Medicine
2. Identify Serum Cytokine Correlates of Future Neurological and Neuropsychological Deficits in Pediatric Traumatic Cases
   Deepak Aggarwal, MD
   Trauma Centre, All India Institute of Medical Sciences
3. To Study the Role of Recombinant Human Erythropoietin in Trauma Victims with Hemorrhagic Shock: An In vitro Approach through Stem Cell Stimulation
   Sanjeev Bhoi, MD JPN
   Apex Trauma Centre, All India Institute of Medical Sciences
4. Decreasing Nosocomial Pneumonias after Emergency Department and Field Intubations
   Steven Bird, MD
   University of Massachusetts Medical School
5. Which Healthcare Workers Were Most Affected During the Spring 2009 H1N1 Pandemic? The Impact of the H1N1 Pandemic on Healthcare Worker Absentee & Influenza A (H1N1) Infection Rates
   Robert Bristow, MD
   New York Presbyterian Hospital
6. The Efficacy of Platelet Transfusion in Patients Receiving Antiplatetelet Therapy That Sustain Traumatic or Non-Traumatic Intracranial Hemorrhage
   Mark Cipolle, MD, PhD, FACS, FCCM
   Christiana Health Care System
7. Lessons Learned From the H1N1 Pandemic and Implications for the Future
   Daniel Fagbuyi, MD
   Children's National Medical Center
8. Utility of Bedside Cardiac Ultrasound During Emergency Department and In-Hospital Cardiac Arrest, Identification of Futile Resuscitative Efforts
   Romolo Gaspari, MD
   University of Massachusetts
9. Association Between Periodontal Disease, Inflammation and Adverse Outcomes in Critically Ill Emergency Department Patients
   Lawrence Glickman, PhD
   University of North Carolina
10. Clinical-Molecular Prognostic Factors for Severity of Seasonal and H1N1 (Swine) Influenza Infection
    Seth Glickman, MD
    University of North Carolina
11. Benchmarking for a Statistical Model for Predicting Diagnosis and Prognosis of Ventilator-Associated Pneumonia
    Edward Mascha, MD
    University of Louisville
12. Effect of Head of Bed Angle on Weaning from Mechanical Ventilation
    Mark Mazer, MD
    Brody School of Medicine, East Carolina University
13. Error Reduction and Improved Survival for Early Goal Directed Therapy in Acute Resuscitation of Sepsis Patients in the Emergency Department with Simulation Practice for Resident and Attending Team Building Education
    Dave Milzman, MD
    Georgetown University School of Medicine/Washington Hospital Center
14. Pharmacist Counseling to Improve Compliance with Information Prescriptions
    Robert O’Connor, MD, MPH
    University of Virginia
15. Pulmonary Function and Neurodevelopmental Outcomes in Children Who Survive ALI/ARDS: The Long Term Impact of Acute Lung Injury in Children
    Michael Quasney
    Medical College of Wisconsin
16. Randomized Placebo controlled trial (Factorial design) of Progesterone with or without Hypothermia in Subjects with Acute Severe Traumatic Brain Injury
    Sumit Sinha, MD JPN
    Apex Trauma Centre, All India Institute of Medical Sciences
17. Standard Language Development for Data Sharing
    Kristan Staudenmayer, MD
    Stanford University

2010 Clinical Proposals

1. Prolonged Prophylactic Moderate Hypothermia Followed by Slow Rewarming in Large Primary Supratentorial Intracerebral Hemorrhage
   Laith Altaweel
   INOVA Fairfax
2. Validation of a Gene Expression Profile for Ischemic Stroke and Outcome Prediction
   Taura Barr
   West Virginia University
3. Proposed Strategy for the Integration of ICU Services in the WWAMI Region
   Satish Bhagwanjee
   University of Washington Medical Center
4. Hypotension as a Risk Factor for Acute Renal Failure in Surgical Patients Admitted to the ICU with Previously Normal Renal Function
   James Blum
   University of Michigan
5. Feasibility and Acceptability of a Genotype-Specific Randomized Controlled Trial (RCT) of Pain Treatment in a Burn Population
   Bruce Cairns
   University of North Carolina
6. Impact of a Simplified ST-elevation Assessment Triage Tool (STat) on Time to Diagnosis and Treatment of ST-elevation Myocardial Infarction and Acute Coronary Syndrome
   Charles Cairns
   University of North Carolina
7. Variability in Management of Acute Airway Disease in Emergency and Critical Care
   Charles Cairns
   University of North Carolina
8. Therapeutic Hypothermia for Control of Elevated Intracranial Pressure in Patients with Severe Traumatic Brain Injury
   Mark Cipolle
   Christiana Care Health System
9. Intraoperative Alerts for the Management of Patients with Preexisting Hypoxia and Potential Acute Lung Injury
   Jesse Ehrenfeld
   Vanderbilt University
10. Effects of a Systematic Team Approach to Guide Early Mobilization in Surgical ICU Patients
    Matthias Eikermann
    Massachusetts General Hospital and Harvard Medical School
11. Association of Vitamin D Deficiency with Increased Severity of Respiratory Infection in Hospitalized Emergency Department Patients
    Larry Glickman
    University of North Carolina
12. Clinical and Molecular Prognostic Factors for Severity of Influenza Infection in the Emergency Department
    Seth Glickman
    University of North Carolina
13. Inpatient Consults for the Critically Ill: a Four-Institution Project Proposal to Improve Consultative Medicine
    Michael Howell
    Beth Israel Deaconess Medical Center
14. Early Propranolol after Traumatic Brain Injury Improves Immune Dysfunction and Reduces Mortality
    Eric Ley Cedars
    Sinai Medical Center
15. Defining Valid Metrics of Error in Acute Care
    John Litell
    Mayo Clinic
16. Perioperative Risk Assessment of Obstructive Sleep Apnea in Surgical Patients
    Jahan Porhomayon
    VA Medical Center
17. Multi-center, International Validation Of An Out-of-hospital Triage Model for Critical Illness
    Christopher Seymour
    University of Washington

2010 Clinical Proposal Updates

1. Progress and Challenges in Creating the Critical Illness and Injury Perioperative Acute and Sustained Kidney Injury Collaborative
   George Frendl, MD, PhD
   Brigham and Women's Hospital
2. Utility of Bedside Cardiac Ultrasound During Emergency Department and In-Hospital Cardiac Arrest, Identification of Futile Resuscitative Efforts
   Romolo Gaspari, MD
   University of Massachusetts
3. Critical Illness Outcomes Study (USCIITG-CIOS)
   Greg S. Martin, MD, MSc
   Emory University
   Jonathan Sevransky, MD, MHS
   Johns Hopkins University

Cobb JP, Cairns CB, Bulger E, Wong HR, Parsons PE, Angus DC, Gentile NT, Hoyt DB, Schwinn DA, Wiener-Kronish JP, Upperman JS. The United States critical illness and injury trials group: an introduction. J Trauma. 2009 Aug;67(2 Suppl):S159-60.

Cobb JP, Ognibene FP, Ingbar DH, Mann HJ, Hoyt DB, Angus DC, Thomas AV Jr, Danner RL, Suffredini AF. Forging a critical alliance: Addressing the research needs of the United States critical illness and injury community. Crit Care Med. 2009 Dec;37(12):3158-60.