External Causes of Morbidity and Mortality, Hypoglycemia, Nosocomial Infection
Conditions
Keywords
tight glycemic control, cardiac surgery
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.
Interventions
DRUGTGC
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.
DRUGConventional 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%.
Sponsors
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 15 years * cardiac surgery with cardiopulmonary bypass
Exclusion criteria
* active infection * insulin allergy * off-pump cardiopulmonary bypass procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nosocomial Infection | within the first 30 day after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Morbidities and All Causes Mortality | within the first 30 days after surgery | 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) |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 99 |
| 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%. | 100 |
| Total | 199 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Change operation | 1 | 0 |
Baseline characteristics
| Characteristic | Tight Glycaemic Control (TGC) | Conventional Glycaemic Control (Control) | Total |
|---|---|---|---|
| Age, Continuous | 54 years | 54 years | 54 years |
| American Society of Anesthesiologists (ASA) class 3 | 86 participants | 87 participants | 173 participants |
| American Society of Anesthesiologists (ASA) class 4 | 12 participants | 10 participants | 22 participants |
| American Society of Anesthesiologists (ASA) class 5 | 1 participants | 3 participants | 4 participants |
| Case status Elective | 76 participants | 72 participants | 148 participants |
| Case status Emergency | 23 participants | 28 participants | 51 participants |
| Mean body mass index (SD), kg/m^2 | 22.7 kg/m^2 STANDARD_DEVIATION 3.9 | 23.3 kg/m^2 STANDARD_DEVIATION 4.4 | 22.8 kg/m^2 STANDARD_DEVIATION 4.1 |
| New York Heart Association (NYHA) class 1 | 8 participants | 5 participants | 13 participants |
| New York Heart Association (NYHA) class 2 | 55 participants | 65 participants | 120 participants |
| New York Heart Association (NYHA) class 3 | 32 participants | 25 participants | 57 participants |
| New York Heart Association (NYHA) class 4 | 4 participants | 5 participants | 9 participants |
| Operation Aneurysmectomy of thoracic aortic aneurysm (TAA) | 0 participants | 3 participants | 3 participants |
| Operation Bentall's operation | 1 participants | 1 participants | 2 participants |
| Operation Closure of septal defects | 10 participants | 5 participants | 15 participants |
| Operation Coronary artery bypass graft | 37 participants | 37 participants | 74 participants |
| Operation More than 1 operation | 7 participants | 8 participants | 15 participants |
| Operation Others | 5 participants | 3 participants | 8 participants |
| Operation Valve replacement / repairment | 39 participants | 43 participants | 82 participants |
| Sex: Female, Male Female | 44 Participants | 43 Participants | 87 Participants |
| Sex: Female, Male Male | 55 Participants | 57 Participants | 112 Participants |
| Smoking status Current | 21 participants | 11 participants | 32 participants |
| Smoking status Former | 28 participants | 32 participants | 60 participants |
| Smoking status Never | 48 participants | 53 participants | 101 participants |
| Smoking status No data | 2 participants | 4 participants | 6 participants |
| Underlying disease:DM No | 81 participants | 83 participants | 164 participants |
| Underlying disease:DM Yes | 18 participants | 17 participants | 35 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 99 | 13 / 100 |
| serious Total, serious adverse events | 23 / 99 | 3 / 100 |
Outcome results
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.
Time frame: within the first 30 day after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tight Glycaemic Control (TGC) | Nosocomial Infection | 17 participants |
| Conventional Glycaemic Control (Control) | Nosocomial Infection | 13 participants |
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)
Time frame: within the first 30 days after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tight Glycaemic Control (TGC) | Morbidities and All Causes Mortality | Hypoglycemia | 23 participants |
| Tight Glycaemic Control (TGC) | Morbidities and All Causes Mortality | Stroke | 6 participants |
| Tight Glycaemic Control (TGC) | Morbidities and All Causes Mortality | New atrial fibrillation | 17 participants |
| Tight Glycaemic Control (TGC) | Morbidities and All Causes Mortality | Acute kidney injury | 5 participants |
| Tight Glycaemic Control (TGC) | Morbidities and All Causes Mortality | Cardiac arrest | 3 participants |
| Tight Glycaemic Control (TGC) | Morbidities and All Causes Mortality | Death | 6 participants |
| Conventional Glycaemic Control (Control) | Morbidities and All Causes Mortality | Cardiac arrest | 1 participants |
| Conventional Glycaemic Control (Control) | Morbidities and All Causes Mortality | Hypoglycemia | 3 participants |
| Conventional Glycaemic Control (Control) | Morbidities and All Causes Mortality | Acute kidney injury | 6 participants |
| Conventional Glycaemic Control (Control) | Morbidities and All Causes Mortality | Stroke | 3 participants |
| Conventional Glycaemic Control (Control) | Morbidities and All Causes Mortality | Death | 8 participants |
| Conventional Glycaemic Control (Control) | Morbidities and All Causes Mortality | New atrial fibrillation | 21 participants |