The Primary Objective of This Study Was to Investigate the Effect of Insulin on Myocardial Perfusion and Cardiac Function in Patients Undergoing Cardiac Surgery for CPB Using Transesophageal Echocardiography (TEE) to Detect CSBF

Study Overview
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Brief Summary
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Perioperative hyperglycaemia can lead to complications such as cardiac dysfunction in patients undergoing cardiac surgery. Regulating blood glucose levels too high or too low can have a detrimental effect on patients. Insulin has a cardioprotective effect. In this project, we use the low-dose insulin relaxation glucose technique to enable insulin to exert its cardioprotective effect while well regulating perioperative blood glucose levels, thus building a system for rapid recovery of perioperative cardiac function in cardiac surgery patients.

Official Title
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The Primary Objective of This Study Was to Investigate the Effect of Insulin on Myocardial Perfusion in Patients Undergoing Cardiac Surgery for CPB Using Transesophageal Echocardiography (TEE) to Detect CSBF and the Secondary Objective Was to Observe the Effect of Insulin on Cardiac Function and Markers of Myocardial Injury

Conditions
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Insulin

Intervention / Treatment
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* Drug: Glucose insulin potassium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 patients with elective first cardiac surgery, aged 45-80 years, who agreed to participate in the trial and signed an informed consent form. Patients with diabetes mellitus, if any, were regularly treated and had preoperative fasting glucose ≤180 mg/dL (10 mmol/L). No consciousness or speech impairment and able to cooperate with neurological physical examinations, cognitive function tests and other neurological functional assessments. No preoperative neurocognitive impairment, Mini Mental State Examination (MMSE) score: illiterate ≥ 17, primary school ≥ 20, secondary school and above ≥ 24, and Montreal Cognitive Assessment (MoCA) score ≥ 26. 26 points. No preoperative anxiety or depression, with a Hamilton Anxiety Scale (HAMA) score ≤ 7 and a Hamilton Depression Scale (HAMD) score ≤ 7. Pre-operative neurological physical examination National Institute of Health Stroke Scale (NIHSS) score ≤ 4, no new intracranial infarction, bleeding, tumour, inflammation, etc. within 3 months prior to surgery. Correction of anemia, hypoproteinemia and other nutritional status prior to surgery. Exclusion Criteria: Emergency cardiac surgery. Non-CPB cardiac surgery. Severe heart failure with left ventricular ejection fraction <30%. Contraindications to TEE. Renal disease requiring replacement therapy. Combined multi-organ insufficiency. Severe infection requiring continuous antibiotic therapy. Significant application of hormonal or non-steroidal anti-inflammatory agents within the last 2 weeks. Neurological or psychiatric diagnoses that could affect neurocognitive performance or neurocognitive testing, such as severe traumatic brain injury or substance abuse. Prior neurodegenerative or psychiatric disorders. Severe audiovisual impairment and inability to communicate.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glucose-insulin-potassium<br> | Drug: Glucose insulin potassium<br>* 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<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the coronary sinus blood flow spectrum | coronary sinus blood flow spectrum changes such as SVTI、DVTI、AVTI are assessed by TEE | 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 | Changes in left ventricular diastolic function are assessed by TEE, such as changes in pulmonary venous blood flow | from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure) | The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery | into ICU 30 minutes | 
| Changes in the level of Cardiac output | The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery | into ICU 30 minutes | 
| Changes in the level of Heart Rate | The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery | into ICU 30 minutes | 
| Changes in the level of SVR | The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery | into ICU 30 minutes | 
| Changes in the level of SVRI | The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery | into ICU 30 minutes | 
| Changes in the level of Cardiac index | The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery | into ICU 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin, Perioperative period, Blood glucose, Heart protection