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

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

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.

Study Overview

• Status: Completed
• Conditions: Insulin
• Intervention / Treatment: Drug: Glucose insulin potassium

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China
      • the Affiliated Hospital of Yangzhou University, Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Glucose-insulin-potassium	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yangzhou University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: May 15, 2022
• First Submitted That Met QC Criteria: July 17, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Insulin; Blood glucose; Perioperative period; Heart protection
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 20220515

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No