The primary goal of the career development activities described in this proposal is for Dr. Lillian Kao, an academic general surgeon, to acquire the knowledge, skills, and experience required to conduct high quality patient-oriented research, particularly studies of perioperative infections and multicenter clinical trials of interventions that cannot be adequately evaluated within a single center. The University of Texas-Houston provides extensive resources to the candidate including the Clinical Research Curriculum and Mentorship Program, the Masters Degree Program in Clinical Research, the General Center for Clinical Research, and a large, heterogeneous surgical population.
The specific aims of the proposal are: (1) to complete a Master's Degree in Clinical Research focused on her research goals;(2) to receive intensive mentoring from a dedicated team that is led by Kevin Lally, one of only a few surgeons to have successfully organized and directed multicenter trials, and that includes faculty well known for their expertise in inflammatory mediators and hyperglycemia in surgical patients (David Mercer, Steven Wolf);and (3) to conduct a 2-center explanatory trial as the first trial of strict glycemic control for surgical patients with necrotizing soft tissue infection (NSTI), The primary objective is to verify feasibility of the intervention, provide unbiased and evidence-based estimates of treatment effects, and obtain data needed for Dr. Kao to design and direct a larger multicenter trial if necessary. The 2-center trial (n >100) will have adequate power to identify a 30% difference in favorable outcome defined as discharge alive from the hospital without an amputation in less than the median number of hospital days. Secondary objectives include evaluation of specific hypotheses relating the intervention to cytokine and neutrophil responses. These preliminary data will provide the basis for future research and grant applications, lend insight into the mechanisms by which hyperglycemia results in adverse effects, and improve outcome through the development of evidence-based therapeutic strategies for patient care.
