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Tight Glycaemic Control During Cardiac Surgery (TGC)

This study has been terminated.
(Hypoglycaemia is significantly higher in TGC)
Sponsor:
Information provided by (Responsible Party):
Panthila Rujirojindakul, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01225159
First received: July 29, 2010
Last updated: November 15, 2015
Last verified: November 2015
Results First Received: April 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Nosocomial Infection
External Causes of Morbidity and Mortality
Hypoglycemia
Interventions: Drug: TGC
Drug: Conventional glycaemic 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
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
  Description
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  
NOT COMPLETED     1     0  
Change operation                 1                 0  



  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.
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
  Description
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 mL.kg-1.h-1 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  
Number of Participants  
[units: participants]
  99     100     199  
Age  
[units: years]
Median (Inter-Quartile Range)
  54  
  (38.0 to 63.5)  
  54  
  (45.0 to 65.2)  
  54  
  (41.5 to 65)  
Gender  
[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]
     
1     8     5     13  
2     55     65     120  
3     32     25     57  
4     4     5     9  
American Society of Anesthesiologists (ASA) class [2]
[units: participants]
     
3     86     87     173  
4     12     10     22  
5     1     3     4  
Operation  
[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  
[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.
[2]

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




  Outcome Measures
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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
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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
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  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.Panthila Rujirojindakul, Staff
Organization: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand
phone: +66 74 45 1651
e-mail: rpanthi@medicine.psu.ac.th



Responsible Party: Panthila Rujirojindakul, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01225159     History of Changes
Other Study ID Numbers: SUB.EC 51-1008-08-1-1
Study First Received: July 29, 2010
Results First Received: April 14, 2014
Last Updated: November 15, 2015
Health Authority: Thailand: Ethical Committee