Tight Glycaemic Control During Cardiac Surgery

Not Applicable

Terminated

• Conditions: Nosocomial Infection; Hypoglycemia; External Causes of Morbidity and Mortality
• Interventions: Drug: Conventional glycaemic control; Drug: TGC

• Registration Number: NCT01225159
• Lead Sponsor: Prince of Songkla University

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 Timeline

• Study Start: 2008-09
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Results First Submitted: 2014-04-14
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-15
• Last Update Submitted: 2015-11-15
• Results First Posted: 2015-12-18
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age > 15 years
• cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional glycaemic control (Control)	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%.
Tight glycaemic control (TGC)	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.

Primary Outcome Measures

Name	Time	Method
Nosocomial Infection	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 Outcome Measures

Name	Time	Method
Morbidities and All Causes Mortality	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)

Trial Locations

Locations (1)

Songklanagarind Hospital, Faculty of Medicine, PSU; 🇹🇭 Hat Yai, Songkhla, Thailand