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Hypoglycaemia is significantly higher in TGC
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To determine whether intraoperative tight glycaemic control can reduce postoperative infection, morbidity and mortality
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Panthila Rujirojindakul, M.D. | Faculty of Medicine, Prince of Songkla University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Songklanagarind Hospital, Faculty of Medicine, PSU | Hat Yai | Changwat Songkhla | 90110 | Thailand |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tight Glycaemic Control (TGC) | Allocated to intensive group (n = 100)
|
| FG001 | Conventional Glycaemic Control (Control) | Allocated to control group (n = 100) • Received allocated intervention (n = 100) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline and clinical characteristics of the study patients did not significantly differ between the two groups. There were 18 diabetic patients in the intensive group and 17 diabetic patients in the control group, and there was no difference in terms of the diabetic treatment given (P = 0.77).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | within the first 30 day after surgery |
|
30 days postoperative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tight Glycaemic Control (TGC) | Allocated to control group (n = 100)
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Serious | Non-systematic Assessment | Hypoglycemia was defined as blood glucose < 60 mg/dl ( 3.3 mmol / l). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection rate | Infections and infestations | Serious | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Panthila Rujirojindakul, Staff | Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand | +66 74 45 1651 | rpanthi@medicine.psu.ac.th |
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| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
|
| 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%. |
|
|
| BG001 | 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%. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Mean body mass index (SD), kg/m^2 | Mean | Standard Deviation | kg/m^2 |
|
| Smoking status | Number | participants |
|
| New York Heart Association (NYHA) class | Class I: Cardiac disease, but no symptoms and no limitation in ordinary physical activity, Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity, Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity, Class IV: Severe limitations. Experiences symptoms even while at rest. | Number | participants |
|
| American Society of Anesthesiologists (ASA) class | ASA classification defined according to American Society of Anesthesiologists that divided into 4 classes: ASA class 1: healthy patient ASA class 2: mild systemic disease ASA class 3: uncontrolled systemic disease ASA class 4: incapacitated patient ASA class 5: moribund | Number | participants |
|
| Operation | Number | participants |
|
| Case status | Number | participants |
|
| Underlying disease:DM | Number | participants |
|
Allocated to intensive group (n = 100)
• Received allocated intervention (n = 100)
|
|
| 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) | Posted | Number | participants | within the first 30 days after surgery |
|
|
|
| 23 |
| 99 |
| 17 |
| 99 |
| EG001 | Conventional Glycaemic Control (Control) | Allocated to intensive group (n = 100) • Received allocated intervention (n = 100) | 3 | 100 | 13 | 100 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008722 | Methods |
| New atrial fibrillation |
|
| Acute kidney injury |
|
| Cardiac arrest |
|
| Death |
|