Tight Glycaemic Control During Cardiac Surgery (TGC)

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. Identifier: NCT01225159
Recruitment Status : Terminated (Hypoglycaemia is significantly higher in TGC)
First Posted : October 20, 2010
Results First Posted : December 18, 2015
Last Update Posted : December 18, 2015
Information provided by (Responsible Party):
Panthila Rujirojindakul, Prince of Songkla University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Nosocomial Infection
External Causes of Morbidity and Mortality
Interventions: Drug: TGC
Drug: Conventional glycaemic control

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Tight Glycaemic Control (TGC)

Allocated to intensive group (n = 100)

  • Received allocated intervention (n = 99)
  • Did not receive allocated intervention: change operation (n = 1)
Conventional Glycaemic Control (Control)

Allocated to control group (n = 100)

• Received allocated intervention (n = 100)

Participant Flow:   Overall Study
    Tight Glycaemic Control (TGC)   Conventional Glycaemic Control (Control)
STARTED   100   100 
COMPLETED   99   100 
Change operation                1                0 

  Baseline Characteristics

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.
Baseline and clinical characteristics of the study patients did not significantly differ between the two groups. There were 18 diabetic patients in the intensive group and 17 diabetic patients in the control group, and there was no difference in terms of the diabetic treatment given (P = 0.77).

Reporting Groups
Tight Glycaemic Control (TGC) TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 and was adjusted to maintain blood glucose levels 80-150 mg/dL.
Conventional Glycaemic Control (Control) Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.
Total Total of all reporting groups

Baseline Measures
   Tight Glycaemic Control (TGC)   Conventional Glycaemic Control (Control)   Total 
Overall Participants Analyzed 
[Units: Participants]
 99   100   199 
[Units: Years]
Median (Inter-Quartile Range)
 (38.0 to 63.5) 
 (45.0 to 65.2) 
 (41.5 to 65) 
[Units: Participants]
Female   44   43   87 
Male   55   57   112 
Mean body mass index (SD), kg/m^2 
[Units: Kg/m^2]
Mean (Standard Deviation)
 22.7  (3.9)   23.3  (4.4)   22.8  (4.1) 
Smoking status 
[Units: Participants]
Current   21   11   32 
Former   28   32   60 
Never   48   53   101 
No data   2   4   6 
New York Heart Association (NYHA) class [1] 
[Units: Participants]
 8   5   13 
 55   65   120 
 32   25   57 
 4   5   9 
[1] Class I: Cardiac disease, but no symptoms and no limitation in ordinary physical activity, Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity, Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, Class IV: Severe limitations. Experiences symptoms even while at rest.
American Society of Anesthesiologists (ASA) class [1] 
[Units: Participants]
 86   87   173 
 12   10   22 
 1   3   4 

ASA classification defined according to American Society of Anesthesiologists that divided into 4 classes:

ASA class 1: healthy patient ASA class 2: mild systemic disease ASA class 3: uncontrolled systemic disease ASA class 4: incapacitated patient ASA class 5: moribund

[Units: Participants]
Valve replacement / repairment   39   43   82 
Coronary artery bypass graft   37   37   74 
Closure of septal defects   10   5   15 
Bentall's operation   1   1   2 
Aneurysmectomy of thoracic aortic aneurysm (TAA)   0   3   3 
More than 1 operation   7   8   15 
Others   5   3   8 
Case status 
[Units: Participants]
Elective   76   72   148 
Emergency   23   28   51 
Underlying disease:DM 
[Units: Participants]
Yes   18   17   35 
No   81   83   164 

  Outcome Measures

1.  Primary:   Nosocomial Infection   [ Time Frame: within the first 30 day after surgery ]

2.  Secondary:   Morbidities and All Causes Mortality   [ Time Frame: within the first 30 days after surgery ]

  Serious Adverse Events

  Other Adverse Events

  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
No text entered.

  More Information

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

Results Point of Contact:  
Name/Title: Dr.Panthila Rujirojindakul, Staff
Organization: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand
phone: +66 74 45 1651

Responsible Party: Panthila Rujirojindakul, Prince of Songkla University Identifier: NCT01225159     History of Changes
Other Study ID Numbers: SUB.EC 51-1008-08-1-1
First Submitted: July 29, 2010
First Posted: October 20, 2010
Results First Submitted: April 14, 2014
Results First Posted: December 18, 2015
Last Update Posted: December 18, 2015