Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353275
Status:
TERMINATED
Last Update Posted:
2018-11-21
First Post:
2006-07-17
Brief Title:
Hyperglycemia in Surgical Infections
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Studies on Hyperglycemia in Surgical Infections
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty in enrolling eligible patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23RR020020-01A1 | NIH | None | httpsreporternihgovquickSearch1K23RR020020-01A1 |