Trial Outcomes & Findings for Tight Glycaemic Control During Cardiac Surgery (NCT NCT01225159)
NCT ID: NCT01225159
Last Updated: 2015-12-18
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
within the first 30 day after surgery
Results posted on
2015-12-18
Participant Flow
Participant milestones
| Measure |
Tight Glycaemic Control (TGC)
Allocated to intensive group (n = 100)
* Received allocated intervention (n = 99)
* Did not receive allocated intervention: change operation (n = 1)
|
Conventional Glycaemic Control (Control)
Allocated to control group (n = 100)
• Received allocated intervention (n = 100)
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
99
|
100
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Tight Glycaemic Control (TGC)
Allocated to intensive group (n = 100)
* Received allocated intervention (n = 99)
* Did not receive allocated intervention: change operation (n = 1)
|
Conventional Glycaemic Control (Control)
Allocated to control group (n = 100)
• Received allocated intervention (n = 100)
|
|---|---|---|
|
Overall Study
Change operation
|
1
|
0
|
Baseline Characteristics
Tight Glycaemic Control During Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Tight Glycaemic Control (TGC)
n=99 Participants
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)
n=100 Participants
Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
New York Heart Association (NYHA) class
4
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
54 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Mean body mass index (SD), kg/m^2
|
22.7 kg/m^2
STANDARD_DEVIATION 3.9 • n=5 Participants
|
23.3 kg/m^2
STANDARD_DEVIATION 4.4 • n=7 Participants
|
22.8 kg/m^2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
|
Smoking status
Current
|
21 participants
n=5 Participants
|
11 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Smoking status
Former
|
28 participants
n=5 Participants
|
32 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Smoking status
Never
|
48 participants
n=5 Participants
|
53 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
Smoking status
No data
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
New York Heart Association (NYHA) class
1
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
New York Heart Association (NYHA) class
2
|
55 participants
n=5 Participants
|
65 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
New York Heart Association (NYHA) class
3
|
32 participants
n=5 Participants
|
25 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) class
3
|
86 participants
n=5 Participants
|
87 participants
n=7 Participants
|
173 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) class
4
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) class
5
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Operation
Valve replacement / repairment
|
39 participants
n=5 Participants
|
43 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Operation
Coronary artery bypass graft
|
37 participants
n=5 Participants
|
37 participants
n=7 Participants
|
74 participants
n=5 Participants
|
|
Operation
Closure of septal defects
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Operation
Bentall's operation
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Operation
Aneurysmectomy of thoracic aortic aneurysm (TAA)
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Operation
More than 1 operation
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Operation
Others
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Case status
Elective
|
76 participants
n=5 Participants
|
72 participants
n=7 Participants
|
148 participants
n=5 Participants
|
|
Case status
Emergency
|
23 participants
n=5 Participants
|
28 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Underlying disease:DM
Yes
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Underlying disease:DM
No
|
81 participants
n=5 Participants
|
83 participants
n=7 Participants
|
164 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within the first 30 day after surgeryInfection 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.
Outcome measures
| Measure |
Tight Glycaemic Control (TGC)
n=99 Participants
Allocated to control group (n = 100)
* Received allocated intervention (n = 99)
* Did not receive allocated intervention: change operation (n = 1)
|
Conventional Glycaemic Control (Control)
n=100 Participants
Allocated to intensive group (n = 100)
• Received allocated intervention (n = 100)
|
|---|---|---|
|
Nosocomial Infection
|
17 participants
|
13 participants
|
SECONDARY outcome
Timeframe: within the first 30 days after surgerymorbidities 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)
Outcome measures
| Measure |
Tight Glycaemic Control (TGC)
n=99 Participants
Allocated to control group (n = 100)
* Received allocated intervention (n = 99)
* Did not receive allocated intervention: change operation (n = 1)
|
Conventional Glycaemic Control (Control)
n=100 Participants
Allocated to intensive group (n = 100)
• Received allocated intervention (n = 100)
|
|---|---|---|
|
Morbidities and All Causes Mortality
Hypoglycemia
|
23 participants
|
3 participants
|
|
Morbidities and All Causes Mortality
Stroke
|
6 participants
|
3 participants
|
|
Morbidities and All Causes Mortality
New atrial fibrillation
|
17 participants
|
21 participants
|
|
Morbidities and All Causes Mortality
Acute kidney injury
|
5 participants
|
6 participants
|
|
Morbidities and All Causes Mortality
Cardiac arrest
|
3 participants
|
1 participants
|
|
Morbidities and All Causes Mortality
Death
|
6 participants
|
8 participants
|
Adverse Events
Tight Glycaemic Control (TGC)
Serious events: 23 serious events
Other events: 17 other events
Deaths: 0 deaths
Conventional Glycaemic Control (Control)
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tight Glycaemic Control (TGC)
n=99 participants at risk
Allocated to control group (n = 100)
* Received allocated intervention (n = 99)
* Did not receive allocated intervention: change operation (n = 1)
|
Conventional Glycaemic Control (Control)
n=100 participants at risk
Allocated to intensive group (n = 100)
• Received allocated intervention (n = 100)
|
|---|---|---|
|
Endocrine disorders
Hypoglycemia
|
23.2%
23/99 • 30 days postoperative
|
3.0%
3/100 • 30 days postoperative
|
Other adverse events
| Measure |
Tight Glycaemic Control (TGC)
n=99 participants at risk
Allocated to control group (n = 100)
* Received allocated intervention (n = 99)
* Did not receive allocated intervention: change operation (n = 1)
|
Conventional Glycaemic Control (Control)
n=100 participants at risk
Allocated to intensive group (n = 100)
• Received allocated intervention (n = 100)
|
|---|---|---|
|
Infections and infestations
Infection rate
|
17.2%
17/99 • Number of events 17 • 30 days postoperative
|
13.0%
13/100 • Number of events 13 • 30 days postoperative
|
Additional Information
Dr.Panthila Rujirojindakul, Staff
Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand
Phone: +66 74 45 1651
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place