Safety and Efficacy of Tight Glycaemic Control During Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Prince of Songkla University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Nosocomial Infection
Study Overview
Brief Summary
To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age > 15 years
- •cardiac surgery with cardiopulmonary bypass
Exclusion Criteria
- •active infection
- •insulin allergy
- •off-pump cardiopulmonary bypass procedures
Arms & Interventions
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: TGC (Drug)
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: Conventional glycaemic control (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Morbidities and All Causes Mortality(within the first 30 days after surgery)
Investigators
Panthila Rujirojindakul
Assistant Professor
Prince of Songkla University