The Association Between Peri-Operative Hyperglycemia and Major Morbidity and Mortality

This study has been terminated.
(potential harm of insulin infusion outweights the benefit.)
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00487162
First received: June 13, 2007
Last updated: February 20, 2014
Last verified: February 2014
Results First Received: December 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hyperglycemia
Interventions: Procedure: strict glycemic control
Drug: conventional glycemic control

  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
enrollment period 6/07-3/09. potential subjects were recruited from the pre-operative admission unit and were screened if there ages were 18-90,undergoing general anesthesia for surgical procedures greater than 2 hours.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized to a specific study arm based on a computer generated randomization table. 49 participants are included in the baseline characteristic module because although 56 signed consent, some subjects withdrew the consent prior to study procedures and several withdrawn by attending anesthesiologist.

Reporting Groups
  Description
Conventional Glycemic Control Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to thie care provider discretion.
Intensive Glycemic Control In the intensive treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50ml of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg / dL on two consecutive samples and will be adjusted to maintain the blood glucose level between 80 and 110 mg / dL. Adjustments will be made according to the University Hospital's ICU Adult Insulin Infusion Protocol - modified 10/1/07 (Appendix A). When the blood glucose level falls below 80 mg / dL, the insulin infusion will be tapered and discontinued. For patients going to the ICU after surgery, insulin infusions will be continued according to the University Hospital's ICU Adult Insulin Infusion Protocol under the direction of the ICU staff. For patients not being to the ICU after surgery, insulin infusions will be tapered to off after the final hourly blood glucose determination at three hours after the completion of surgery.

Participant Flow:   Overall Study
    Conventional Glycemic Control     Intensive Glycemic Control  
STARTED     30     26  
COMPLETED     28     21  
NOT COMPLETED     2     5  
Adverse Event                 0                 1  
Physician Decision                 0                 1  
Withdrawal by Subject                 2                 3  



  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.
males and females between the ages of 18 and 89. No analysis was done as the study was terminated due to patient safety concerns.

Reporting Groups
  Description
Conventional Glycemic Control Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200 mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.
Strict Glycemic Control In the intensive treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50mL of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg/dL and will be adjusted to maintain the blood glucose level between 80 and 110 mg/dL.
Total Total of all reporting groups

Baseline Measures
    Conventional Glycemic Control     Strict Glycemic Control     Total  
Number of Participants  
[units: participants]
  28     21     49  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     25     20     45  
>=65 years     3     1     4  
Gender  
[units: participants]
     
Female     12     13     25  
Male     16     8     24  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Wound Infection   [ Time Frame: 7-10 days post op ]

2.  Secondary:   Hemodynamic Instability   [ Time Frame: 0-48 hours post op ]


  Serious Adverse Events


  Other Adverse Events


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


Limitations and Caveats
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
Study was terminated. No final conclusion drawn. A sentinel article was published in Feb 2009 issue of Anesthesiology which questioned the safety of intense insulin therapy/strict glycemic control.  


Results Point of Contact:  
Name/Title: J. Jeffrey Freda, MD, MBA
Organization: UMDNJ-NJMS
phone: 973 972-5007
e-mail: jjfreda@umdnj.edu


Publications:

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00487162     History of Changes
Other Study ID Numbers: 0120070093
Study First Received: June 13, 2007
Results First Received: December 3, 2010
Last Updated: February 20, 2014
Health Authority: United States: Federal Government