Hyperglycemia in Surgical Infections
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First Received Date ICMJE | July 17, 2006 | ||||
Last Updated Date | July 11, 2011 | ||||
Start Date ICMJE | August 2009 | ||||
Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00353275 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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. |
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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 ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Necrotizing Fasciitis | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Estimated Enrollment ICMJE | 100 | ||||
Completion Date | July 2011 | ||||
Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00353275 | ||||
Other Study ID Numbers ICMJE | HSC-MS-04-209, 1 K23 RR020020-01A1 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Lillian S. Kao, MD, Associate Professor, UT Health Science Center at Houston | ||||
Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||
Collaborators ICMJE | National Institutes of Health (NIH) | ||||
Investigators ICMJE |
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Information Provided By | The University of Texas Health Science Center, Houston | ||||
Verification Date | July 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |