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Intensive Insulin Therapy in Patients Undergoing Coronary Artery Bypass Surgery (CABG)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01361594
First Posted: May 27, 2011
Last Update Posted: December 31, 2014
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.
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
Results First Submitted: December 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetes
Interventions: Other: Regular insulin (intensive treatment)
Other: Regular Insulin (conventional treatment)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Emory University Hospital, Emory University Hospital - Midtown and Grady Hospital

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients undergoing coronary artery bypass surgery (CABG) that develop hyperglycemia (defined as a blood glucose >140) intraoperatively or in an intenstive care unit (ICU) post-surgical procedure. 33 patients withdrawn prior to randomization, due to various reasons, including surgery cancellation, transportation to a different hospital, etc.

Reporting Groups
  Description
Intensive Insulin Treatment

Intensive insulin treatment (BG target: 100-140 mg/dL)

Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL

Conventional Insulin Treatment

Conventional insulin treatment (BG target: 141-180 mg/dl)

Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl


Participant Flow:   Overall Study
    Intensive Insulin Treatment   Conventional Insulin Treatment
STARTED   152   153 
COMPLETED   151   151 
NOT COMPLETED   1   2 
Withdrawal by Subject                1                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only subjects that completed the study were accounted for in the baseline characteristics.

Reporting Groups
  Description
Intensive Insulin Treatment

Intensive insulin treatment (BG target: 100-140 mg/dL)

Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL

Conventional Insulin Treatment

Conventional insulin treatment (BG target: 141-180 mg/dl)

Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl

Total Total of all reporting groups

Baseline Measures
   Intensive Insulin Treatment   Conventional Insulin Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 151   151   302 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   79   80   159 
>=65 years   72   71   143 
Gender 
[Units: Participants]
     
Female   45   39   84 
Male   106   112   218 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects That Were Diagnosed for Peri-operative Complications   [ Time Frame: Within 6 months of hospitalization ]

2.  Primary:   Hospital Mortality   [ Time Frame: average 1 month during the hospitalization ]

3.  Secondary:   Glycemic Control   [ Time Frame: average 1 month during the hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Major Cardiovascular Events   [ Time Frame: average 1 month during the hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Acute Renal Failure   [ Time Frame: average 1 month during the hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Respiratory Failure, Defined as PaO2 Value < 60 mm Hg While Breathing Air or a PaCO2 > 50 mm Hg.   [ Time Frame: average 1 month during the hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   ICU and Hospital Length of Stay, and ICU Readmissions   [ Time Frame: average 1 month during the hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Surgical Wound Infection   [ Time Frame: average 1 month during the hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Pneumonia (CDC Criteria)   [ Time Frame: average 1 month during the hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Cerebrovascular Events   [ Time Frame: average 1 month during the hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Secondary:   Duration of Ventilatory Support and ICU Readmission   [ Time Frame: average 1 month during the hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Secondary:   Thirty Day Mortality   [ Time Frame: within 30 days of discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Secondary:   Number of Hospital Readmissions and Emergency Room Visits   [ Time Frame: Within 30 days after discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

14.  Secondary:   Incidence of Organ Failures Assessed by the Daily SOFA Score   [ Time Frame: average 1 month during the hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

15.  Secondary:   Measures of Inflammation   [ Time Frame: average 1 month during the hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

16.  Secondary:   Major Cardiovascular Events   [ Time Frame: within 3 months after discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

17.  Secondary:   Surgical Wound Infection   [ Time Frame: within 3 months after discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

18.  Secondary:   Pneumonia (CDC Criteria)   [ Time Frame: Within 3 months after discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

19.  Secondary:   Cerebrovascular Events   [ Time Frame: within 3 months after discharge ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Guillermo Umpierrez
Organization: Emory University
phone: 404-778-1665
e-mail: geumpie@emory.edu



Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT01361594     History of Changes
Other Study ID Numbers: IRB00048356
00048356-2010 ( Other Identifier: Other )
First Submitted: February 3, 2011
First Posted: May 27, 2011
Results First Submitted: December 18, 2014
Results First Posted: December 31, 2014
Last Update Posted: December 31, 2014