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Tight Glycaemic Control During Cardiac Surgery (TGC)

This study has been terminated.
(Hypoglycaemia is significantly higher in TGC)
Sponsor:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01225159
First received: July 29, 2010
Last updated: October 20, 2010
Last verified: August 2008
History of Changes
  Purpose

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


Condition Intervention
Nosocomial Infection
Interleukines
Glycemic Control
Cardiac Surgery With Cardiopulmonary Bypass Circuit
 Drug: TGC blood sugar 80-150 mg%
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:

U.S. FDA Resources

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 ]

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%), 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) Drug: TGC blood sugar 80-150 mg%
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
No Intervention: Conventional glycaemic control 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
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
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

No publications provided

Responsible Party: Faculty of Medicine, 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
Last Updated: October 20, 2010
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
Cross Infection
Infection

ClinicalTrials.gov processed this record on May 21, 2013