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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23RR020020-05
Application #
7862529
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Program Officer
Wilde, David B
Project Start
2006-07-01
Project End
2011-06-30
Budget Start
2010-07-01
Budget End
2011-06-30
Support Year
5
Fiscal Year
2010
Total Cost
$135,000
Indirect Cost
Name
University of Texas Health Science Center Houston
Department
Surgery
Type
Schools of Medicine
DUNS #
800771594
City
Houston
State
TX
Country
United States
Zip Code
77225
Kao, Lillian S; Millas, Stefanos G; Pedroza, Claudia et al. (2012) Should perioperative supplemental oxygen be routinely recommended for surgery patients? A Bayesian meta-analysis. Ann Surg 256:894-901
Kao, Lillian S; Ghaferi, Amir A; Ko, Clifford Y et al. (2011) Reliability of superficial surgical site infections as a hospital quality measure. J Am Coll Surg 213:231-5
Kao, Lillian S; Lew, Debbie F; Arab, Samer N et al. (2011) Local variations in the epidemiology, microbiology, and outcome of necrotizing soft-tissue infections: a multicenter study. Am J Surg 202:139-45
Kao, Lillian S; Meeks, Derek; Moyer, Virginia A et al. (2009) Peri-operative glycaemic control regimens for preventing surgical site infections in adults. Cochrane Database Syst Rev :CD006806
Kao, Lillian S; Tyson, Jon E; Blakely, Martin L et al. (2008) Clinical research methodology I: introduction to randomized trials. J Am Coll Surg 206:361-9
Kao, Lillian S; Green, Charles E (2008) Analysis of variance: is there a difference in means and what does it mean? J Surg Res 144:158-70