Department of Medicine
Clinical investigation in Pulmonary and Critical Care Medicine is a vital part of our activity. This patient-oriented research takes place broadly in both the outpatient clinics and the intensive care units. Participation by our fellows is extensive in both arenas, with one or more fellows involved in outpatient pulmonary clinical investigation as well as the critical care clinical investigations. Fellowship involvement in clinical investigation is supported by a National Institute of Health NHLBI funded Research Training in Respiratory Biology training grant.

A large number of faculty are devoted to these efforts. Drs. Imre Noth, Mary Strek and Edward Naurekas form the nucleus of our outpatient clinical investigation team, while Drs. Brian Gehlbach, Jesse Hall, and John Kress run critical care clinical investigation. Each team is organized by full time study coordinators, who serve to facilitate protocol submission for IRB evaluation, data management of ongoing trials, study contract and budget organization, organization of responsibilities of research associates and ancillary study staff, and coordination of follow up for patients involved in ongoing clinical trials.

The outpatient clinical investigation team has performed a large variety of studies that have led to a number of new and exciting pharmaceuticals reaching approval and general public usage. The pulmonary section conducts trials on a constant basis that offer a variety of opportunities to try novel medications such as VCAM inhibitors, cytokines, and monoclonal antibodies. Other investigations have described new roles for inhaled corticosteroids, beta agonists and other immunomodulatory drugs. Participation in trials is attractive to patients and has substantially grown the outpatient clinical experience, and has also provided a window of opportunity for substantial patient education. By disease category, our primary focuses are in asthma, emphysema/chronic bronchitis and idiopathic pulmonary fibrosis. We anticipate the opening of a sarcoidosis center focusing on both patient care and clinical investigation related to this disorder. With multiple studies operating at all times, any patient with an interest in participating will find a trial appropriate to their lung condition actively recruiting or being implemented in the near future. Patients with interests in such state-of-the-art medicine are encouraged to contact our study programs.

Clinical research in critical care is also very active and we have performed numerous successful trials involving intensive care unit patients. In the past 15 years, more than 3800 patients have been enrolled in more than 80 individual protocols. These studies have yielded more than 60 publications.

Active areas of investigation of critical illness include sedation of mechanically ventilated patients, severe asthma, sickle cell anemia, morbid obesity and respiratory failure, mechanical ventilation of critically ill patients with severe airflow obstruction, outcomes of critically ill patients with cancer and advanced liver disease, and informed consent in the ICU patient. Our current areas of research are focused on sedation of mechanically ventilated patients; evaluation of patients with acute lung injury, ARDS and other forms of pulmonary edema; evaluation of medical education in the intensive care unit; monitoring in the intensive care unit; outcomes prediction in critically ill geriatric patients; and sleep in critically ill patients. Clinical research in critical care enjoys a wide variety of grant support, including NIH K23 for ongoing sedation studies and the ACCP-CHEST Foundation of the American College of Chest Physicians Geriatric Development Research Award for the study of long-term functional outcomes in critically ill geriatric patients. The University of Chicago is also a member of the ARDS network involved in the Fluids and Catheters Treatment (FACTT) trial.


Section of Pulmonary/Critical Care Clinical Research Faculty and Their Interests:

Brian Gehlbach,M.D.
  Dr. Gehlbach is studying the long-term functional status of survivors of critical illness with the goal of identifying which patient characteristics or illnesses are associated with long-term debility. He is also interested in the effects of critical illness on sleep, and whether the sleep of ICU patients can be improved.


Jesse Hall,M.D.
  Dr. Hall has worked to develop the intensive care units of The University of Chicago to not only provide exemplary care but to serve as well as laboratories for bedside clinical investigation in critically ill patients. This research focuses upon the pathophysiology of respiratory and circulatory failure; pharmacologic interventions including inhalation therapy, vasoactive drugs, and sedatives; and outcomes from critical illness. The tools for conducting these studies include bedside physiologic measurement; serum, alveolar lavage, and other tissue analysis of cellular and molecular markers and mediators of human disease; and clinical epidemiologic analysis of large databases. The research team includes four faculty members, full-time study coordinators, as well as research trainees at the medical student, resident, and fellow level. In addition to internal projects, a large number of multi-center trials are ongoing, including participation in the NIH-funded ARDS network.


John P. Kress,M.D.
  Dr. Kress is studying strategies for sedation of critically ill patients requiring mechanical ventilation. In addition to this, he is leading clinical research projects in assessing pulmonary edema in critically ill patients with the use of serum beta natiuretic peptide, medical education in the ICU in the context of new ACGME resident work guidelines, implementation of protocols in the ICU and the utility of the physical examination compared to invasive monitoring in critically ill patients.


Edward Naureckas,M.D.
  Dr. Naureckas research involves the secondary analysis of existing databases. Interests include usage patterns of asthma medications to highlight variations in care, and the effect of medication usage on asthma outcomes. Dr. Naureckas is a member of the EPA sponsored Environmental Statistics Center. He is also a co-investigator in the American Lung Association Asthma Clinical Research Network where he participates in large multi-center trials of asthma therapy.


John McConville,M.D.
  Dr. John McConville, working with Dr. Julian Solway, has focused on the role of serum response factor's cytoplasmic-nuclear translocation in the accumulation of smooth muscle specific proteins. This work, carried out in a cell culture system, could have implications for parallel mechanisms that may operate during airway smooth muscle hypertrophy that occurs in asthma. Additionally, Dr. McConville is designing clinical studies to investigate the interaction between obesity and asthma.


Imre Noth,M.D.
  Dr. Noth is an authority in Interstitial lung diseases while conducting an active pulmonary practice and attending both on pulmonary consults and the medical intensive care unit. Dr. Noth conducts clinical trails in Asthma, COPD and Interstitial lung diseases, while also participating in novel studies.


Mary Strek,M.D.
  Dr. Strek conducts clinical research studies to develop new medications for the treatment of asthma, COPD, bronchiectasis, pulmonary fibrosis and other pulmonary diseases. The goal of these studies is to provide improved treatment for patients with Pulmonary Diseases; some studies also provide insight into the pathophysiology of the disease process itself. Dr. Strek has a clinical interest in patients with all forms of obstructive lung disease (asthma, COPD and bronchiectasis), restrictive lung diseases especially Idiopathic Pulmonary Fibrosis and sarcoidosis and patients with lung disease as a result of connective tissue disorders.