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Trial record 5 of 16 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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Necrotizing Fasciitis
Interventions Drug: Strict Glycemic control
Drug: Conventional Glycemic Control
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Strict Glycemic Control Conventional Glycemic Control
Hide Arm/Group Description Blood glucose target range is 80-110 mg/dL. Blood glucose target range is 110-140 mg/dL.
Period Title: Overall Study
Started 2 3
Completed 2 3
Not Completed 0 0
Arm/Group Title Strict Glycemic Control Conventional Glycemic Control Total
Hide Arm/Group Description Blood glucose target range is 80-110 mg/dL. Blood glucose target range is 110-140 mg/dL. Total of all reporting groups
Overall Number of Baseline Participants 2 3 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 5 participants
59  (11) 59  (5) 59  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Female
0
   0.0%
2
  66.7%
2
  40.0%
Male
2
 100.0%
1
  33.3%
3
  60.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
  66.7%
2
  40.0%
White
2
 100.0%
1
  33.3%
3
  60.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 3 participants 5 participants
2 3 5
Weight  
Mean (Full Range)
Unit of measure:  Pounds
Number Analyzed 2 participants 3 participants 5 participants
169
(158 to 180)
240
(215 to 272)
212
(158 to 272)
Height  
Mean (Full Range)
Unit of measure:  Inches
Number Analyzed 2 participants 3 participants 5 participants
66
(65 to 67)
65
(63 to 68)
66
(63 to 68)
1.Primary Outcome
Title Infectious Morbidity
Hide Description [Not Specified]
Time Frame Duration of hospital stay, an average of 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.
Arm/Group Title Strict Glycemic Control Conventional Glycemic Control
Hide Arm/Group Description:
Blood glucose target range is 80-110 mg/dL.
Blood glucose target range is 110-140 mg/dL.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Composite Outcome (Favorable Outcome Defined as Discharge Home, Without an Amputation, in Less Than the Median Hospital Stay for Survivors)
Hide Description [Not Specified]
Time Frame Duration of hospital stay
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.
Arm/Group Title Strict Glycemic Control Conventional Glycemic Control
Hide Arm/Group Description:
Blood glucose target range is 80-110 mg/dL.
Blood glucose target range is 110-140 mg/dL.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Organ Failure
Hide Description [Not Specified]
Time Frame Duration of hospital stay
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.
Arm/Group Title Strict Glycemic Control Conventional Glycemic Control
Hide Arm/Group Description:
Blood glucose target range is 80-110 mg/dL.
Blood glucose target range is 110-140 mg/dL.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Hypoglycemia
Hide Description [Not Specified]
Time Frame Duration of hospital stay
Hide Outcome Measure Data
Hide Analysis Population Description
The study was stopped because it appeared we would not be able to enroll enough patients into the study by the time funding would conclude. Because only a total of 5 patients were enrolled and underwent study procedures, there was not enough data to be analyzed.
Arm/Group Title Strict Glycemic Control Conventional Glycemic Control
Hide Arm/Group Description:
Blood glucose target range is 80-110 mg/dL.
Blood glucose target range is 110-140 mg/dL.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Strict Glycemic Control Conventional Glycemic Control
Hide Arm/Group Description Blood glucose target range is 80-110 mg/dL. Blood glucose target range is 110-140 mg/dL.
All-Cause Mortality
Strict Glycemic Control Conventional Glycemic Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Strict Glycemic Control Conventional Glycemic Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Strict Glycemic Control Conventional Glycemic Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/3 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Lillian S. Kao
Organization: UT Health Science Center at Houston
Phone: 713-566-5095
Responsible Party: Lillian Kao, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00353275     History of Changes
Other Study ID Numbers: HSC-MS-04-209
1K23RR020020-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 17, 2006
First Posted: July 18, 2006
Results First Submitted: February 19, 2014
Results First Posted: May 5, 2014
Last Update Posted: November 21, 2018