Tight Glycaemic Control During Cardiac Surgery (TGC)

Prince of Songkla University

Status: Terminated

Conditions: Hypoglycemia; External Causes of Morbidity and Mortality; Nosocomial Infection

Treatments: Drug: Conventional glycaemic control; Drug: TGC

Study type: Interventional

Funder types: Other

Identifiers

NCT01225159

SUB.EC 51-1008-08-1-1

Details and patient eligibility

About

To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 15 years
• cardiac surgery with cardiopulmonary bypass

Exclusion criteria

• active infection
• insulin allergy
• off-pump cardiopulmonary bypass procedures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Tight glycaemic control (TGC)

Experimental group

Description:

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.

Treatment:

Drug: TGC

Conventional glycaemic control (Control)

Placebo Comparator group

Description:

Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.

Treatment:

Drug: Conventional glycaemic control