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

NCT ID: NCT05464966

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-06-30

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.

Conditions

Insulin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Glucose-insulin-potassium

Group Type: EXPERIMENTAL

Glucose insulin potassium

Intervention Type: DRUG

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

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yangzhou University

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

20220515

Identifier Type: -

Identifier Source: org_study_id