Hyperglycemia in Surgical Infections

Studies on Hyperglycemia in Surgical Infections

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.

Study Overview

• Status: Terminated
• Conditions: Necrotizing Fasciitis
• Intervention / Treatment: Drug: Strict Glycemic control; Drug: Conventional Glycemic Control

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77026/ 77030
      • LBJ General Hospital/ UT health Science Center-Houston
    • San Antonio, Texas, United States, 78234
      • Brooke Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Strict glycemic control with a blood glucose target range of 80-110 mg/dL	Drug: Strict Glycemic control; Blood glucose target range is 80-110 mg/dL.
Other: 2; Conventional glycemic control with blood glucose target range of 110-140 mg/dL	Drug: Conventional Glycemic Control; Blood glucose target range is 110-140 mg/dL.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Organ Failure	Duration of hospital stay
Hypoglycemia	Duration of hospital stay

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Lillian S Kao, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 17, 2006
• First Submitted That Met QC Criteria: July 17, 2006
• First Posted (Estimate): July 18, 2006

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Strict glycemic control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Musculoskeletal Diseases; Hyperglycemia; Fasciitis; Fasciitis, Necrotizing
• Other Study ID Numbers: HSC-MS-04-209; 1K23RR020020-01A1 (U.S. NIH Grant/Contract)