An interventional study of Strict Glycemic control and Conventional Glycemic Control in Necrotizing Fasciitis, sponsored by The University of Texas Health Science Center, Houston. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-21.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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.
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.
28 studies on the registry are indexed under Fasciitis, Necrotizing; 8 are open to participants now.
This study's enrollment of 5 is below the median of 74 across 12 interventional studies indexed under Fasciitis, Necrotizing.
Browse Fasciitis, Necrotizing studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
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Exclusion Criteria:
Strict glycemic control with a blood glucose target range of 80-110 mg/dL
Drug: Strict Glycemic control
Conventional glycemic control with blood glucose target range of 110-140 mg/dL
Drug: Conventional Glycemic Control
Blood glucose target range is 80-110 mg/dL.
Blood glucose target range is 110-140 mg/dL.
Infectious Morbidity
Time frame: 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)
Time frame: Duration of hospital stay
Organ Failure
Time frame: Duration of hospital stay
Hypoglycemia
Time frame: Duration of hospital stay
| Milestone | Strict Glycemic Control | Conventional Glycemic Control |
|---|---|---|
| Started | 2 | 3 |
| Completed | 2 | 3 |
| Not completed | 0 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Strict Glycemic Control | — | 0/2 (0%) | 0/2 (0%) |
| Conventional Glycemic Control | — | 0/3 (0%) | 0/3 (0%) |
| Age, Continuous(years) | Strict Glycemic Control | Conventional Glycemic Control | Total |
|---|---|---|---|
| Mean | 59 ± 11 | 59 ± 5 | 59 ± 7 |
| Sex: Female, Male(Participants) | Strict Glycemic Control | Conventional Glycemic Control | Total |
|---|---|---|---|
| Female | 0 | 2 | 2 |
| Male | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Strict Glycemic Control | Conventional Glycemic Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 |
| White | 2 | 1 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Strict Glycemic Control | Conventional Glycemic Control | Total |
|---|---|---|---|
| United States | 2 | 3 | 5 |
| Weight(pounds) | Strict Glycemic Control | Conventional Glycemic Control | Total |
|---|---|---|---|
| Mean | 169 (158 to 180) | 240 (215 to 272) | 212 (158 to 272) |
| Height(inches) | Strict Glycemic Control | Conventional Glycemic Control | Total |
|---|---|---|---|
| Mean | 66 (65 to 67) | 65 (63 to 68) | 66 (63 to 68) |
This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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