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

Insulin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05464966
• Other study ID #: 20220515
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin

Intervention

Drug:
• Glucose 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

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yangzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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