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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
First received
Last updated
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
Health authority
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

Study Design


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
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