Necrotizing Fasciitis
Conditions
Keywords
Strict glycemic control
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.
Interventions
Blood glucose target range is 80-110 mg/dL.
Blood glucose target range is 110-140 mg/dL.
Sponsors
National Institutes of Health (NIH)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infectious Morbidity | Duration of hospital stay, an average of 2 weeks |
| Composite Outcome (Favorable Outcome Defined as Discharge Home, Without an Amputation, in Less Than the Median Hospital Stay for Survivors) | Duration of hospital stay |
Secondary
| Measure | Time frame |
|---|---|
| Organ Failure | Duration of hospital stay |
| Hypoglycemia | Duration of hospital stay |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Strict Glycemic Control Blood glucose target range is 80-110 mg/dL. | 2 |
| Conventional Glycemic Control Blood glucose target range is 110-140 mg/dL. | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Strict Glycemic Control | Conventional Glycemic Control | Total |
|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 11 | 59 years STANDARD_DEVIATION 5 | 59 years STANDARD_DEVIATION 7 |
| Height | 66 inches | 65 inches | 66 inches |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
| Weight | 169 pounds | 240 pounds | 212 pounds |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Composite Outcome (Favorable Outcome Defined as Discharge Home, Without an Amputation, in Less Than the Median Hospital Stay for Survivors)
Time frame: Duration of hospital stay
Population: The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.
Primary
Infectious Morbidity
Time frame: Duration of hospital stay, an average of 2 weeks
Population: The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.
Secondary
Hypoglycemia
Time frame: Duration of hospital stay
Population: The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.
Secondary
Organ Failure
Time frame: Duration of hospital stay
Population: The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.