Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT01361594
First received: February 3, 2011
Last updated: December 18, 2014
Last verified: December 2014
Results First Received: December 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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140) intraoperatively or in an intenstive care unit (ICU) post-surgical procedure. 33 patients withdrawn prior to randomization, due to various reasons, including surgery cancellation, transportation to a different hospital, etc.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  
Number of Participants  
[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.   Safety Issue:   Yes

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

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

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.   Safety Issue:   Yes

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.   Safety Issue:   Yes

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

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

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

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.   Safety Issue:   Yes

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

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.   Safety Issue:   Yes

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.   Safety Issue:   Yes

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

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

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

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

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


  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


No publications provided


Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT01361594     History of Changes
Other Study ID Numbers: IRB00048356, 00048356-2010
Study First Received: February 3, 2011
Results First Received: December 18, 2014
Last Updated: December 18, 2014
Health Authority: United States: Institutional Review Board