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NCT Number: NCT05464966

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 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.

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Key information

Conditions

Insulin Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

included

  • age 55-80 years, ASA grade II-III, regardless of gender,
  • BMI 18.5-28.0 kg/m2,
  • scheduled for elective coronary artery bypass grafting (CABG), valve repair or replacement, or a combination of these procedures with cardiopulmonary bypass.

Exclusion criteria

  • non-first cardiac surgery;
  • emergency cardiac surgery;
  • severe heart failure with preoperative left ventricular ejection fraction <30%;
  • contraindication to TEE;
  • kidney disease requiring replacement therapy;
  • combined with multi-organ insufficiency;
  • Severe infection requiring continuous antibiotic treatment;
  • use of large doses of hormone or nonsteroidal anti-inflammatory drugs within the last 2 weeks.
  • 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

  • unplanned secondary CPB;
  • need for intra-aortic balloon pump technical support during the study period;
  • TEE image acquired with poor quality.

Treatment and study plan

Glucose insulin potassium

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

Primary outcomes

  1. Changes in the coronary sinus blood flow spectrum

    Time frame: 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

  2. Changes in left ventricular diastolic function

    Time frame: 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 outcomes

  1. Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)

    Time frame: 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

  2. Changes in the level of Cardiac output

    Time frame: 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

  3. Changes in the level of Heart Rate

    Time frame: 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

  4. Changes in the level of SVR

    Time frame: 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

  5. Changes in the level of SVRI

    Time frame: 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

  6. Changes in the level of Cardiac index

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2022
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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