Clinical trial NCT00353275: Hyperglycemia in Surgical Infections
Official title: Studies on Hyperglycemia in Surgical Infections
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Necrotizing Fasciitis
Keywords: Strict glycemic control
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-07-18
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate two glycemic control regimens on clinical outcome in patients with necrotizing soft tissue infections. Secondary aim is to evaluate the inflammatory and immune responses to the glycemic control regimens.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Infectious Morbidity
timeFrame: Duration of hospital stay, an average of 2 weeks
measure: Composite Outcome (Favorable Outcome Defined as Discharge Home, Without an Amputation, in Less Than the Median Hospital Stay for Survivors)
timeFrame: Duration of hospital stay
Secondary outcomes:
measure: Organ Failure
timeFrame: Duration of hospital stay
measure: Hypoglycemia
timeFrame: Duration of hospital stay
Other outcomes:
Locations:
city: Houston
country: United States
facility: LBJ General Hospital/ UT health Science Center-Houston
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lillian S Kao, MD
role: PRINCIPAL_INVESTIGATOR
References: