Tight Glycaemic Control During Cardiac Surgery

NCT01225159 | Terminated Results DMC

• 1 other identifier: SUB.EC 51-1008-08-1-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nosocomial Infection; External Causes of Morbidity and Mortality; Hypoglycemia

Keywords

tight glycemic control; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Morbidities and All Causes Mortality

  within the first 30 days after surgery

Study Arms (2)

Tight glycaemic control (TGC)

EXPERIMENTAL

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.

Drug: TGC

Conventional glycaemic control (Control)

PLACEBO COMPARATOR

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

Drug: Conventional glycaemic control

Interventions

TGC DRUG

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.

Also known as: intensive glycaemic control

Tight glycaemic control (TGC)

Conventional glycaemic control DRUG

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

Also known as: Control group

Conventional glycaemic control (Control)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 15 years
• cardiac surgery with cardiopulmonary bypass

You may not qualify if:

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

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

Songklanagarind Hospital, Faculty of Medicine, PSU

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Cross Infection; Hypoglycemia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Dr.Panthila Rujirojindakul, Staff
• Organization: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand

rpanthi@medicine.psu.ac.th

+66 74 45 1651

Study Officials

• Panthila Rujirojindakul, M.D.

  Faculty of Medicine, Prince of Songkla University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: October 20, 2010
• Study Start: September 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 18, 2015
• Results First Posted: December 18, 2015

Record last verified: 2015-11

Locations

TH (1)