Funded Research
| Colorado PETAL Clinical Center | |
| Funding Agency | National Heart, Lung, and Blood Institute (NHLBI) |
| Description / Aims | The goal of this application is to participate in the selection and conduct of clinical trials for the prevention and early treatment of acute lung injury across a network of 12 clinical centers. Our clinical center includes two academic and four community hospitals in the greater Denver area and a robust infrastructure for recruitment of critically ill emergency department and intensive care unit patients into clinical trials. |
| National Center for Advancing Translational Sciences (NCATS) | |
| Funding Agency | Colorado Clinical and Translational Sciences Institute |
| Description / Aims | The CTSA to the University of Colorado Denver supports the institutional academic home for research and training in clinical and translational sciences. |
| Prevention and Early Treatment of Acute Lung Injury (PETAL) Network: “Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS) | |
| Funding Agency | National Heart, Lung, and Blood Institute (NHLBI) |
| Description / Aims | The goal of this phase III trial is to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) or a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension. |
| Brain Oxygen Optimization in Severe Traumatic Brain Injury – Phase 3 (BOOST-3) | |
| Funding Agency | National Institute of Neurological Diseases and Stroke (NINDS) |
| Description / Aims | The goal of this study to determine if there is evidence of clinical efficacy of a treatment protocol based on brain tissue oxygenation (PbtO2) monitoring compared to treatment based on intracranial pressure (ICP) monitoring alone. |
| EMS-TruShoC’ – A Prospective Trial of Low-Dose, High-Frequency, On-Site Training to Improve Trauma Field Care in Austere Settings | |
| Funding Agency | Defense Health Agency (J9, Research and Development Directorate); US Department of the Air Force (59th Medical Wing) |
| Description / Aims | The goal of this project is to implement EMS-TruShoC in an austere setting and assess the resultant educational and clinical outcomes. These prehospital trauma resuscitation concepts will inform future efforts to translate into USSOF and conventional military prehospital training and sustaining knowledge. |
| Precision Medicine Approach to Vitamin D3 Administration in Critical Illness | |
| Funding Agency | Funding Agency: National Heart, Lung, and Blood Institute (NHLBI) |
| Description / Aims | The goal of this study is using a precision medicine approach to investigate the clinical, genetic, and biochemical factors that determine response to vitamin D3 administration in critical illness. |
| The Impact of Fluid Resuscitation on Glycocalyx Degradation in Septic Shock | |
| Funding Agency | National Heart, Lung, and Blood Institute (NHLBI) |
| Description / Aims | The goal of this project is to determine the mechanism of intravenous fluid resuscitation in glycocalyx degradation and adverse clinical outcomes in septic shock. |
| Establishing the Epidemiology and Outcomes of Combat-Relevant Prolonged Trauma Care: A Prospective Multicenter Prehospital Pilot Study in South Africa | |
| Funding Agency | Department of Defense (USAMCMR) |
| Description / Aims | The goal of this project is to assess the effect of prolonged durations of prehospital care, and key prehospital interventions, on morbidity and mortality of patients with combat-like injuries. |
| Multicenter Implementation Trial of Targeted Normoxia Strategy to Define Oxygen Requirements for Major Burn Patients: An Approach to Reduce Warfighter Morbidity, Deployed Logistical Burden of Oxygen, and Readiness Costs | |
| Funding Agency | Department of Defense/ Medical Technology Enterprise Consortium (MTEC) |
| Description / Aims | The goal of this study is to determine the feasibility, safety, and effectiveness of the targeted normoxia approach to conserve oxygen and improve clinical outcomes in major burn patients. |
| Multicenter Implementation Trial of Targeted Normoxia Strategy to Define Oxygen Requirements for Combat Casualty Care | |
| Funding Agency | Department of Defense (Joint Warfighter Medical Research Program) |
| Description / Aims | The goal of this study is to determine the feasibility, safety, and effectiveness of the targeted normoxia approach to conserve oxygen and improve clinical outcomes in critically injured patients |
| Innovative Methods to Evaluate the Role of Influenza Vaccines in Attenuating Severe Disease in Adults | |
| Funding Agency | Centers for Disease Control and Prevention (CDC) |
| Description / Aims | The goal of this study is to understand the role of influenza infection and other viral infections including COVID-19 in critical illness, define and sub-phenotype severe influenza disease, and quantify the effectiveness of influenza vaccines for mitigating influenza-associated morbidity and mortality. |
| Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease (ORCHID) | |
| Funding Agency | National Heart, Lung, and Blood Institute (NHLBI) |
| Description / Aims | This project will be a randomized controlled trial to compare the safety and efficacy of hydroxychloroquine versus placebo in hospitalized patients with laboratory-confirmed COVID-19 |
| CORAL: PETAL COVID-19 Observational Study | |
| Funding Agency | National Heart, Lung, and Blood Institute (NHLBI) |
| Description / Aims | Observational study of hospitalized patients with COVID-19 using both retrospective and prospective methods. |
| Clinical Trial of COVID-19 Convalescent Plasma in Outpatients (C3PO) | |
| Funding Agency | National Heart, Lung, and Blood Institute (NHLBI) |
| Description / Aims | The goal of this study to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. |
| Internationally Coordinating Center for ACTIV-3 Trial Initiative | |
| Funding Agency | National Heart, Lung, and Blood Institute (NHLBI) |
| Description / Aims | The goal of this project is to design and oversee the trial, drafting, and revising standard operating procedure documents and FAQs, interactions with DSMB, NHLBI, International Coordinating Center (ICC), running and attending meetings, and serving as an on-call PETAL Investigator for the ACTIV-3 COVID-19 protocol. |
| An end-user assessment of the novel iView video laryngoscope | |
| Funding Agency | USAF/AFMC |
| Description / Aims | The goal of this study to is to compare the use of the novel iView laryngoscope to traditional video laryngoscopy during acute airway management. |
| Passive Immunity for Our Nation (PassItOn) | |
| Funding Agency | National Center for Advancing Translational Sciences (NCATS) |
| Description / Aims | The goal of this phase III trial is to compare the efficacy and safety of convalescent plasma versus placebo among adults hospitalized with COVID-19. |
| Epidemiology and Outcomes of Combat-Relevant Prolonged Trauma Care: A Prospective Multicenter Prehospital Study in South Africa | |
| Funding Agency | Department of Defense/U.S. Army |
| Description / Aims | The goal of this project is to conduct a multicenter epidemiologic study that assesses the effect of prolonged durations of prehospital care, and key prehospital interventions, on morbidity and mortality of civilian patients with combat-like injuries. |
| Adult Inpatient/Outpatient VE Case-Control Study | |
| Funding Agency | Centers for Disease Control and Prevention (CDC) |
| Description / Aims | The goal of this study is to evaluate vaccine effectiveness of SARS-CoV-2 vaccination against symptomatic, medically attended SARS-CoV-2 infection by vaccine product. |
| Implementation and Effectiveness of Monoclonal Antibodies to Treat High-Risk Outpatients with COVID-19 | |
| Funding Agency | National Center for Advancing Translational Sciences (NCATS) |
| Description / Aims | The goal of this project is to develop, implement, and evaluate strategies to optimize equitable nMAb access in Colorado and determine the effectiveness and safety of nMAb treatment in high-risk COVID-19 outpatients. |
| Trial of Early Antiviral Therapies during Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19 to Reduce the Burden of Illness for U.S. Service Members | |
| Funding Agency | FY20 BA 6.4 CARES Act Research and Development (RDT&E) |
| Description / Aims | The goal of this phase III trial is to test the efficacy and safety of the antiviral agent lopinavir/ritonavir to prevent disease progression and improve recovery in outpatients with COVID-19. |
| Human IFN Beta-1a In Severe CoronavirUS (HIBISCUS) | |
| Funding Agency | FY20 BA 6.4 CARES Act Research and Development (RDT&E) |
| Description / Aims | The goal of this phase III trial is to test the efficacy and safety of intravenous interferon beta-1a in the treatment of patients with severe hypoxemic respiratory failure/ARDS due to COVID-19 |
| Re-evaluation of Systemic Early neuromuscular blockade (ROSE) | |
| Funding Agency | NHLBI/Massachusetts General Hospital Prevention and Early Treatment of Acute Lung Injury Network |
| Description / Aims | The goal of this phase III trial is to determine the efficacy and safety of neuromuscular blockade in reducing mortality of emergency department and intensive care unit patients with moderate-severe acute respiratory distress syndrome. |
| Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET) | |
| Funding Agency | NHLBI/Massachusetts General Hospital Prevention and Early Treatment of Acute Lung Injury Network |
| Description / Aims | The goal of this phase III trial is to determine if early administration of vitamin D reduces 90-day mortality in critically ill, vitamin D deficient patients at high-risk for developing acute respiratory distress syndrome (ARDS). I lead the conduct of a 3,000 patient, 48-institution randomized controlled trial. |
| Targeting Steroid Resistance During Acute Exacerbations of COPD with Respiratory Failure – The AECOPD Resistance Study | |
| Funding Agency | NIH/Colorado Clinical and Translational Sciences Institute (CCTSI) Team Science Award (PI: Vandivier) |
| Description / Aims | The goals of this study are to determine the mechanisms and clinical implications of steroid resistance in emergency department patients during acute exacerbation of chronic obstructive pulmonary disease with respiratory failure who require mechanical ventilation and ICU admission. |
| Targeted Normoxia to Conserve Oxygen and Improve Clinical Outcomes in Combat-Injured Special Operations Forces | |
| Funding Agency | Department of Defense/U.S. Special Operations Command |
| Description / Aims | The goal of this application is to determine the feasibility, safety, and potential effectiveness of targeted normoxia as a strategy to conserve oxygen and improve clinical outcomes in critically ill trauma patients. |
| Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients (VIOLET BUD) | |
| Funding Agency | Vanderbilt - National Heart, Lung, and Blood Institute (NHLBI) |
| Description / Aims | The goal of this project is to determine the effect of vitamin D repletion on long-term cognitive outcomes in critically ill patients. |
| Vitamin C, Thiamine, and Steroids in Sepsis (VICTAS) | |
| Funding Agency | Johns Hopkins University -The Marcus Foundation, Inc |
| Description / Aims | The goal of this study is to test the efficacy of vitamin C, thiamine, and steroids in reducing in-hospital mortality in critically ill patients with sepsis. |
| Influenza Vaccine Effectiveness for Preventing Laboratory-Confirmed Severe Influenza-Associated Illness in US Adults | |
| Funding Agency | Centers for Disease Control and Prevention (CDC) |
| Description / Aims | The goal of this study is to understand the role of influenza infection in critical illness and the effectiveness of influenza vaccines for mitigating influenza-associated morbidity and mortality. |