Tight Glycaemic Control During Cardiac Surgery (TGC)

This study has been terminated.
(Hypoglycaemia is significantly higher in TGC)
Sponsor:
Information provided by (Responsible Party):
Panthila Rujirojindakul, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01225159
First received: July 29, 2010
Last updated: November 15, 2015
Last verified: November 2015
  Purpose
To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality

Condition Intervention
Nosocomial Infection
External Causes of Morbidity and Mortality
Hypoglycemia
Drug: TGC
Drug: Conventional glycaemic control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Tight Glycaemic Control During Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • Nosocomial Infection [ Time Frame: within the first 30 day after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 200
Study Start Date: September 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Other Name: intensive glycaemic control
Placebo Comparator: 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%.
Drug: 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%.
Other Name: Control group

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.
  Eligibility

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 15 years
  • cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

  • active infection
  • insulin allergy
  • off-pump cardiopulmonary bypass procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225159

Locations
Thailand
Songklanagarind Hospital, Faculty of Medicine, PSU
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Panthila Rujirojindakul, M.D. Faculty of Medicine, Prince of Songkla University
  More Information

Responsible Party: Panthila Rujirojindakul, Assistant Professor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01225159     History of Changes
Other Study ID Numbers: SUB.EC 51-1008-08-1-1 
Study First Received: July 29, 2010
Results First Received: April 14, 2014
Last Updated: November 15, 2015
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
tight glycemic control
cardiac surgery

Additional relevant MeSH terms:
Hypoglycemia
Cross Infection
Glucose Metabolism Disorders
Metabolic Diseases
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Insulin
Magnesium Sulfate
Hypoglycemic Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 26, 2016