Tight Glycaemic Control During Cardiac Surgery

Prince of Songkla University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

200

Conditions

Nosocomial Infection External Causes of Morbidity and Mortality Hypoglycemia

Interventions

TGCDRUG

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 controlDRUG

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

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age \> 15 years * cardiac surgery with cardiopulmonary bypass Exclusion Criteria: * active infection * insulin allergy * off-pump cardiopulmonary bypass procedures

Locations (1)

Songklanagarind Hospital, Faculty of Medicine, PSU

Hat Yai, Changwat Songkhla, Thailand

Outcomes

Primary Outcomes

Nosocomial Infection

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.

Time frame: within the first 30 day after surgery

Secondary Outcomes

Morbidities and All Causes Mortality

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)

Time frame: within the first 30 days after surgery

Data from ClinicalTrials.gov

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