NCT00353275

Hyperglycemia in Surgical Infections

Studies on Hyperglycemia in Surgical Infections

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Necrotizing Fasciitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2006-07-18
• Last updated: 2018-11-21
• Results posted: 2014-05-05

Locations

2 sites across 1 country: United States