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Tight Glycaemic Control During Cardiac Surgery (TGC)

This study has been terminated.
(Hypoglycaemia is significantly higher in TGC)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01225159
First Posted: October 20, 2010
Last Update Posted: December 18, 2015
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.
Information provided by (Responsible Party):
Panthila Rujirojindakul, Prince of Songkla University
July 29, 2010
October 20, 2010
April 14, 2014
December 18, 2015
December 18, 2015
September 2008
March 2009   (Final data collection date for primary outcome measure)
Nosocomial Infection [ Time Frame: within the first 30 day after surgery ]
Infection rate referred to the rate of nosocomial infection, including pneumonia, central line infection, surgical wound infection, deep sternal wound infection, urinary tract infection, and sepsis. Infections were defined according to the Centers for Disease Control and Prevention (CDC) definitions, occurring within 30 days postoperative cardiac surgery.
Nosocomial Infection [ Time Frame: within the first 30 day after surgery ]
Complete list of historical versions of study NCT01225159 on ClinicalTrials.gov Archive Site
Morbidities and All Causes Mortality [ Time Frame: within the first 30 days after surgery ]
morbidities defined as hypoglycaemia (blood sugar less than 60 mg/dL), Stroke (focal neurological deficit confirmed with CT or MRI), acute renal failure (rising of creatinine)
Interleukin level [ Time Frame: before induction and at 4 hours after surgery ]
Not Provided
Not Provided
 
Tight Glycaemic Control During Cardiac Surgery
Safety and Efficacy of Tight Glycaemic Control During Cardiac Surgery
To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality
Hyperglycaemia develops frequently in patients undergoing cardiac surgery, especially following cardiopulmonary bypass (CPB). Recent evidence suggests that acute hyperglycaemia adversely affects immune function, wound healing and cardiovascular function.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
  • Nosocomial Infection
  • External Causes of Morbidity and Mortality
  • Hypoglycemia
  • Drug: 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.
    Other Name: intensive glycaemic control
  • Drug: Conventional glycaemic 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%.
    Other Name: Control group
  • Experimental: 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.
    Intervention: Drug: TGC
  • Placebo Comparator: 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%.
    Intervention: Drug: Conventional glycaemic control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
March 2009
March 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age > 15 years
  • cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • active infection
  • insulin allergy
  • off-pump cardiopulmonary bypass procedures
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01225159
SUB.EC 51-1008-08-1-1
Yes
Not Provided
Not Provided
Panthila Rujirojindakul, Prince of Songkla University
Prince of Songkla University
Not Provided
Principal Investigator: Panthila Rujirojindakul, M.D. Faculty of Medicine, Prince of Songkla University
Prince of Songkla University
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP