Hyperglycemia in Surgical Infections

Not Applicable

Terminated

• Conditions: Necrotizing Fasciitis
• Interventions: Drug: Strict Glycemic control; Drug: Conventional Glycemic Control

• Registration Number: NCT00353275
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Study Timeline

• Study First Submitted: 2006-07-17
• Study First Submitted QC: 2006-07-17
• Study First Posted: 2006-07-18
• Study Start: 2009-08
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2014-02-19
• Results First Submitted QC: 2014-04-01
• Results First Posted: 2014-05-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Strict Glycemic control	Strict glycemic control with a blood glucose target range of 80-110 mg/dL
2	Conventional Glycemic Control	Conventional glycemic control with blood glucose target range of 110-140 mg/dL

Primary Outcome Measures

Name	Time	Method
Composite Outcome (Favorable Outcome Defined as Discharge Home, Without an Amputation, in Less Than the Median Hospital Stay for Survivors)	Duration of hospital stay
Infectious Morbidity	Duration of hospital stay, an average of 2 weeks

Secondary Outcome Measures

Name	Time	Method
Organ Failure	Duration of hospital stay
Hypoglycemia	Duration of hospital stay

Trial Locations

Locations (2)

LBJ General Hospital/ UT health Science Center-Houston; 🇺🇸 Houston, Texas, United States

Brooke Army Medical Center; 🇺🇸 San Antonio, Texas, United States