Thomas Jefferson UniversitySidney Kimmel Medical College

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Clinical Trials & Projects in the Division

Clinical research is considered to be vital for the mission of an academic division and typically faculty gravitate to academic centers to participate in scholarship, discovery and innovation. A healthy training environment which includes knowledge creation is an integral part of Pulmonary and Critical Care Medicine Fellowship training as mandated by the Accreditation Committee on Graduate Medical Education andthe Division. Participation in an active research program is an essential component for fellows enrolled in subspecialty fellowship training programs. As such, our program provides an opportunity for fellows to participate in research and other scholarly activities. The program strives to ensure a meaningful, supervised research experience with appropriate protected time. Fellows learn the standards of ethical conduct of research, design and interpretation of research studies, responsible use of informed consent, research methodology, methods of choosing and performing statistical analysis, and interpretation of data.

Scholarship and research come in multiple flavors from sponsored clinical trials (typically multicenter pharma trials with strict study design with random allocation); quality assurance initiatives geared to monitoring, education, and improving compliance of accepted practice; investigator-initiated data collection of a particular disease cohort or intervention; establishment of registries for data or biobanks for future studies; correlative or translational studies involving human specimens to gain proof-of-concept insights into disease mechanisms; and formal controlled laboratory models with experimental design involving mouse models, in-vitro studies, etc. The scholarly activities of the division are complemented by support and expertise from: 1. Jefferson Coordinating Center for Clinical Research (JCCCR), 2. Center for Translational Medicine (CTM), and 3. Graduate Studies Programs.

All of these activities are currently occurring in the Pulmonary & Critical Care division at Thomas Jefferson University / Hospital. Clinicians, clinical scientists, and laboratory scientists are equally engaged and valued. This represents an outstanding environment for growth of a fellow-in-training or academic

Sponsored Clinical Trials

  • Recombinant human angiotensin converting enzyme Type II (rhACE-2) in ARDS. (PI: Bharat Awsare, MD) (Phase II trial, sponsor is GSK).
  • A Post-marketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated with Tyvaso® (Treprostinil) Inhalation Solution. ASPIRE, (PI: Michael Scharf, MD)
  • A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) Treatment in Patients With Moderate to Severe Asthma. Cephalan (PI: Mani S. Kavuru, MD)
  • Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized Controlled Trial of Adults Treated for Endotoxemia and Septic Shock. EUPHRATES. (PI: Michael Baram, MD)
  • A Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Demonstrate the Efficacy and Safety of ACT-293987 in Patients with Pulmonary Arterial Hypertension. Griphon (PI: Michael Scharf, MD)
  • Registry to Prospectively Describe Use of Epoprostenol for Injection ("RTS Epoprostenol") in Patients with Pulmonary Arterial Hypertension *No Longer Enrolling New Patients. PROSPECT (PI: Michael Scharf, MD)
  • COPD Study with a LABA/IC (BI). (PI: William Sexauer, MD)
  • A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of GS-6624 (LOXL2) in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER, Gilead Sciences Inc)(PI: Ross Summer, MD, CoI Drs Kavuru & Weibel)

Quality Assurance/Education Projects

  • Severe sepsis pathway (ED/MICU/Infectious Diseases) with (Drs. Awsare, Flomenberg, and Lopez)
  • Severe sepsis hospital rollout (collaboration with heme/malignancy/onlcology) (Drs. Awsare & Flomenberg)
  • GI bleed pathway (GI/Interventional Radiology) with (Drs. Awsare, Mitchell Conn, and David Eschelman)
  • ABCDE protocol (collaboration with nursing, respiratory therapy, physical therapy, anesthesia/pain service, surgery); MICU initiative
  • Development & Implementation of a multi-disciplinary COPD exacerbation in-patient pathway (Drs Gaurav Kumar, Vaid, Sexauer, Kavuru)
  • A quality improvement project for documentation of family meetings in the medical ICU: (PI: Urvashi. Vaid, MD with fellow Geoffrey Koff, MD and Co-PI: David Oxman, MD)
  • How to teach (3 minute fellow lectures) (Drs Baram & Mangione)

Fellow/Faculty Research-in-Progress Clinical Projects

  • Utility of Rockall score in outcomes in lower GI bleeding (PI: David Manoff, MD & Dr Awsare)
  • Incidence of hyperglycemia in septic shock patients receiving steroids for adrenal insufficiency (PI: Lindsay McCann & Dr. Vaid)
  • Utility of oxygenation index as predictor of failure of conventional ventilation and mortality (PI: Vanjul Agarwal, MD and Roselle Almeida, MD & Drs Baram & Vaid)
  • Code status change following an RRT in an academic medical center: An observational study of patient characteristics and outcomes. (PI: Michael Baram, MD and Co PI: Urvashi Vaid, MD and David Oxman, MD)
  • PAH due to Hep B, C without portal hypertension. Need to define portal hypertension. Do we bring in liver specialists? (PI: Michael L. Scharf, MD)
  • Role of tissue Doppler imaging in assessing RV function prior to/in absence of elevated estimated PA pressures in various chronically at risk populations. Safety of performing ISWT in PAH population Scleroderma? (PI: Michael L. Scharf, MD)
  • Compare 6MWD, ISWT, VO2max in various chronically at risk populations. (PI: Michael L. Scharf, MD)
  • What constitutes and meaningful improvement in ISWT distance? Questionnaire, Functional Class, Pre- and post-therapy CTA imaging of RV size and function (PA caliber) in various chronically at risk populations. (PI: Dr Michael Scharf, with Misha Peter, MD and Dinesh Sharma, MD)
  • Outcomes of percutaneous tracheostomy in the medical ICU: retrospective review (Drs Restrepo & Baram)
  • Utilization of ECMO in the ICU: optimal timing, role of biomarkers, comparison to a national database, etc. (Drs. Kumar Gaurav,Mike Baram, Nick Cavarocchi)
  • Impact of computerized order entry alert on the optimal use of ARDSnet ventilator settings (Drs. Sid Bagga & Michael Baram)
  • Outcome of patients with solitary pulmonary nodules: retrospective chart review (Drs Vanjul Agarwal, Rohit Kumar, Boyd Hehn, Mani Kavuru)

Miscellaneous Clinical Projects involving other disciplines

  • IRB approved for recruitment of patient surrogates to form part of advisory board for PCORI grant application for a new tool "GO-CARE" to assess outcomes and patient/family satisfaction with meetings in the ICU. (PI: Susan Parks, MD Co-PI: Urvashi Vaid, MD and David Oxman, MD)
  • COPD management: medical home in primary care versus subspecialty care (PCORI grant submission) (PI: Lawrence Ward, with Co-Is Drs Rhea Powell, Kavuru, Sexauer)