Insulin
Conditions
Keywords
Insulin, Perioperative period, Blood glucose, Heart protection
Brief summary
The primary objective of this clinical trial was to investigate the effects of insulin on myocardial blood flow reflected by CSBF which was evaluated by TEE. The second aim was to observe the effect of insulin on cardiac function and markers of myocardial damage.
Interventions
DRUGGlucose insulin potassium
After induction of anaesthesia,cardiac systolic-diastolic function was first measured by TEE, GIK solution was continuously pumped until the end of the procedure at a dose of 30 mU/kg/h of insulin, 0.12 g/kg/h of glucose and 0.06 mmol/kg/h of potassium chloride
Sponsors
Yangzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
included 1. age 55-80 years, ASA grade II-III, regardless of gender, 2. BMI 18.5-28.0 kg/m2, 3. scheduled for elective coronary artery bypass grafting (CABG), valve repair or replacement, or a combination of these procedures with cardiopulmonary bypass.
Exclusion criteria
1. non-first cardiac surgery; 2. emergency cardiac surgery; 3. severe heart failure with preoperative left ventricular ejection fraction \<30%; 4. contraindication to TEE; 5. kidney disease requiring replacement therapy; 6. combined with multi-organ insufficiency; 7. Severe infection requiring continuous antibiotic treatment; 8. use of large doses of hormone or nonsteroidal anti-inflammatory drugs within the last 2 weeks. 9. after the patient entered the operating room, if the first blood glucose exceeded 180 mg/dl, a second test was performed 15 minutes later, and if the average of the two blood glucoses exceeded 180 mg/dl, the patient was excluded as well. Elimination criteria included 1. unplanned secondary CPB; 2. need for intra-aortic balloon pump technical support during the study period; 3. TEE image acquired with poor quality.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the coronary sinus blood flow spectrum | from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery | coronary sinus blood flow spectrum changes such as SVTI、DVTI、AVTI are assessed by TEE |
| Changes in left ventricular diastolic function | from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery | Changes in left ventricular diastolic function are assessed by TEE, such as changes in pulmonary venous blood flow |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the level of Heart Rate | into ICU 30 minutes | The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery |
| Changes in the level of SVR | into ICU 30 minutes | The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery |
| Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure) | into ICU 30 minutes | The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery |
| Changes in the level of Cardiac index | into ICU 30 minutes | The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery |
| Changes in the level of SVRI | into ICU 30 minutes | The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery |
| Changes in the level of Cardiac output | into ICU 30 minutes | The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery |
Countries
China
Outcome results
None listed