Hyperglycemia in Surgical Infections

Necrotizing Fasciitis Clinical Trial

Official title:

Studies on Hyperglycemia in Surgical Infections

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00353275
• Other study ID #: HSC-MS-04-209
• Secondary ID: 1K23RR020020-01A
• Status: Terminated
• Phase: N/A
• Start date: August 2009
• Est. completion date: July 2011

Study information

• Verified date: October 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Necrotizing
• Hyperglycemia
• Necrotizing Fasciitis

Intervention

Drug:
• Strict Glycemic control
Blood glucose target range is 80-110 mg/dL.
• Conventional Glycemic Control
Blood glucose target range is 110-140 mg/dL.

Locations

Country	Name	City	State
United States	LBJ General Hospital/ UT health Science Center-Houston	Houston	Texas
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious Morbidity		Duration of hospital stay, an average of 2 weeks
Primary	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	Organ Failure		Duration of hospital stay
Secondary	Hypoglycemia		Duration of hospital stay