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Trial record 5 of 17 for:    Necrotizing Fascitis

Hyperglycemia in Surgical Infections

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ClinicalTrials.gov Identifier: NCT00353275
Recruitment Status : Terminated (Difficulty in enrolling eligible patients)
First Posted : July 18, 2006
Results First Posted : May 5, 2014
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Lillian Kao, 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.

Condition or disease Intervention/treatment Phase
Necrotizing Fasciitis Drug: Strict Glycemic control Drug: Conventional Glycemic Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Studies on Hyperglycemia in Surgical Infections
Study Start Date : August 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Infectious Morbidity [ Time Frame: Duration of hospital stay, an average of 2 weeks ]
  2. 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 ]

Secondary Outcome Measures :
  1. Organ Failure [ Time Frame: Duration of hospital stay ]
  2. Hypoglycemia [ Time Frame: Duration of hospital stay ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353275


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

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Responsible Party: Lillian Kao, Professor - Surgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00353275     History of Changes
Other Study ID Numbers: HSC-MS-04-209
1K23RR020020-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 18, 2006    Key Record Dates
Results First Posted: May 5, 2014
Last Update Posted: November 21, 2018
Last Verified: October 2018
Keywords provided by Lillian Kao, The University of Texas Health Science Center, Houston:
Strict glycemic control
Additional relevant MeSH terms:
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Fasciitis, Necrotizing
Fasciitis
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Musculoskeletal Diseases
Skin Diseases, Bacterial
Bacterial Infections