Hyperglycemia in Surgical Infections

This is a multi-center explanatory trial of strict glycemic control for surgical patients
with necrotizing soft tissue infection (NSTI). The primary objective of this study is to
verify feasibility of the intervention, provide unbiased and evidence-based estimates of
treatment effects, and obtain data needed to design and direct a larger multi-center trial if
necessary. The multi-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.

Inclusion Criteria:

- Patients will be enrolled at one of the following centers: the LBJ General Hospital
(UT-Houston), the Ben Taub General Hospital (Baylor Houston), The Methodist Hospital
(Texas Medical Center), or the University of Texas Health Science Center at San
Antonio and the Brooke Army Medical Center.

- We will attempt to enroll all eligible patients with a diagnosis of a necrotizing soft
tissue infection (NSTI), including Fournier's gangrene, confirmed in the operating
room regardless of age, ethnicity or gender.

Exclusion Criteria:

- Pregnant patients