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Tight Glycaemic Control During Cardiac Surgery (TGC)

Primary Purpose

Nosocomial Infection, External Causes of Morbidity and Mortality, Hypoglycemia

Status
Terminated
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
TGC
Conventional glycaemic control
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nosocomial Infection focused on measuring tight glycemic control, cardiac surgery

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 15 years
  • cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

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

Sites / Locations

  • Songklanagarind Hospital, Faculty of Medicine, PSU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tight glycaemic control (TGC)

Conventional glycaemic control (Control)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

First Posted
July 29, 2010
Last Updated
November 15, 2015
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT01225159
Brief Title
Tight Glycaemic Control During Cardiac Surgery
Acronym
TGC
Official Title
Safety and Efficacy of Tight Glycaemic Control During Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Hypoglycaemia is significantly higher in TGC
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nosocomial Infection, External Causes of Morbidity and Mortality, Hypoglycemia
Keywords
tight glycemic control, cardiac surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tight glycaemic control (TGC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional glycaemic control (Control)
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
TGC
Other Intervention Name(s)
intensive glycaemic control
Intervention Description
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 Type
Drug
Intervention Name(s)
Conventional glycaemic control
Other Intervention Name(s)
Control group
Intervention Description
Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.
Primary Outcome Measure Information:
Title
Nosocomial Infection
Description
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 Outcome Measure Information:
Title
Morbidities and All Causes Mortality
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 15 years cardiac surgery with cardiopulmonary bypass Exclusion Criteria: active infection insulin allergy off-pump cardiopulmonary bypass procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panthila Rujirojindakul, M.D.
Organizational Affiliation
Faculty of Medicine, Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Songklanagarind Hospital, Faculty of Medicine, PSU
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

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Tight Glycaemic Control During Cardiac Surgery

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