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Trial record 5 of 17 for:    Necrotizing Fascitis

Hyperglycemia in Surgical Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 17, 2006
First Posted Date  ICMJE July 18, 2006
Results First Submitted Date  ICMJE February 19, 2014
Results First Posted Date  ICMJE May 5, 2014
Last Update Posted Date November 21, 2018
Study Start Date  ICMJE August 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2014)
  • Infectious Morbidity [ Time Frame: 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) [ Time Frame: Duration of hospital stay ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2006)
  • Infectious Morbidity
  • Composite Outcome (Favorable Outcome Defined as Discharge Home, Without an Amputation, in Less Than the Median Hospital Stay for Survivors)
Change History Complete list of historical versions of study NCT00353275 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2007)
  • Organ Failure [ Time Frame: Duration of hospital stay ]
  • Hypoglycemia [ Time Frame: Duration of hospital stay ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2006)
  • Organ Failure
  • Sepsis
  • Hypoglycemia
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperglycemia in Surgical Infections
Official Title  ICMJE Studies on Hyperglycemia in Surgical Infections
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Necrotizing Fasciitis
Intervention  ICMJE
  • Drug: Strict Glycemic control
    Blood glucose target range is 80-110 mg/dL.
  • Drug: Conventional Glycemic Control
    Blood glucose target range is 110-140 mg/dL.
Study Arms  ICMJE
  • 1
    Strict glycemic control with a blood glucose target range of 80-110 mg/dL
    Intervention: Drug: Strict Glycemic control
  • 2
    Conventional glycemic control with blood glucose target range of 110-140 mg/dL
    Intervention: Drug: Conventional Glycemic Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 1, 2014)
5
Original Enrollment  ICMJE
 (submitted: July 17, 2006)
100
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00353275
Other Study ID Numbers  ICMJE HSC-MS-04-209
1K23RR020020-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lillian Kao, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Lillian S Kao, MD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP