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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach

1 country

2 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

July 17, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed

3 years until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed

2.8 years until next milestone

Results Posted

Study results publicly available

May 5, 2014

Completed

Last Updated

November 21, 2018

Status Verified

October 1, 2018

Enrollment Period

1.9 years

First QC Date

July 17, 2006

Results QC Date

February 19, 2014

Last Update Submit

October 23, 2018

Conditions

Necrotizing Fasciitis

Keywords

Strict glycemic control

Outcome Measures

Primary Outcomes (2)

Infectious Morbidity
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)
Duration of hospital stay

Secondary Outcomes (2)

Organ Failure
Duration of hospital stay
Hypoglycemia
Duration of hospital stay

Study Arms (2)

1

OTHER

Strict glycemic control with a blood glucose target range of 80-110 mg/dL

Drug: Strict Glycemic control

2

OTHER

Conventional glycemic control with blood glucose target range of 110-140 mg/dL

Drug: Conventional Glycemic Control

Interventions

Strict Glycemic controlDRUG

Blood glucose target range is 80-110 mg/dL.

Conventional Glycemic ControlDRUG

Blood glucose target range is 110-140 mg/dL.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

The University of Texas Health Science Center, Houstonlead
National Institutes of Health (NIH)collaborator

Study Sites (2)

LBJ General Hospital/ UT health Science Center-Houston

Houston, Texas, 77026/ 77030, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

MeSH Terms

Conditions

Fasciitis, Necrotizing

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal Diseases

Results Point of Contact

Title: Dr. Lillian S. Kao
Organization: UT Health Science Center at Houston

Study Officials

Lillian S Kao, MD
The University of Texas Health Science Center, Houston
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor - Surgery

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 18, 2006

Study Start

August 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 21, 2018

Results First Posted

May 5, 2014

Record last verified: 2018-10

Locations

US(2)

Study Stopped

Hyperglycemia in Surgical Infections

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations