Tight Glycaemic Control During Cardiac Surgery

Hypoglycemia Clinical Trial

— TGC  

Official title:

Safety and Efficacy of Tight Glycaemic Control During Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01225159
• Other study ID #: SUB.EC 51-1008-08-1-1
• Status: Terminated
• Phase: N/A
• First received: July 29, 2010
• Last updated: November 15, 2015
• Start date: September 2008
• Est. completion date: March 2009

Study information

• Verified date: November 2015
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• age > 15 years

• cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

• active infection

• insulin allergy

• off-pump cardiopulmonary bypass procedures

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cross Infection
• External Causes of Morbidity and Mortality
• Hypoglycemia
• Nosocomial Infection

Intervention

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.
• 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%.

Locations

Country	Name	City	State
Thailand	Songklanagarind Hospital, Faculty of Medicine, PSU	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within the first 30 day after surgery	Yes
Secondary	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)	within the first 30 days after surgery	Yes