Hyperglycemia in Surgical Infections - Full Text View

Purpose

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.

Condition	Intervention
Necrotizing Fasciitis	Drug: Strict Glycemic control Drug: Conventional Glycemic Control

Drug Information available for:

Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study

Official Title:	Studies on Hyperglycemia in Surgical Infections

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

Infectious morbidity [ Time Frame: Duration of hospital stay ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Organ failure [ Time Frame: Duration of hospital stay ] [ Designated as safety issue: Yes ]
Hypoglycemia [ Time Frame: Duration of hospital stay ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353275

Contacts


Contact: Lillian S. Kao, M.D.	713-607-6433	lillian.s.kao@uth.tmc.edu

Contact: David W. Mercer, M.D.	713-500-6362	david.w.mercer@uth.tmc.edu

Locations


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

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

National Institutes of Health (NIH)

Investigators


Principal Investigator:	Lillian S Kao, MD	The University of Texas Health Science Center, Houston

More Information

Responsible Party:	UT Health Science Center at Houston ( Lillian S. Kao, MD, Associate Professor )
Study ID Numbers:	HSC-MS-04-209, 1 K23 RR020020-01A1
First Received:	July 17, 2006
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00353275
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:

Strict glycemic control

Study placed in the following topic categories:

Bacterial Infections

Metabolic Diseases

Hyperglycemia

Fasciitis, Necrotizing

Skin Diseases

Musculoskeletal Diseases

Necrotizing fasciitis

Skin Diseases, Bacterial

Fasciitis

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 03, 2008

Sponsors and Collaborators:	The University of Texas Health Science Center, Houston National Institutes of Health (NIH)
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00353275