Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin
Keywords: Insulin
Perioperative period
Blood glucose
Heart protection
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 74
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the coronary sinus blood flow spectrum
timeFrame: from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery
measure: Changes in left ventricular diastolic function
timeFrame: 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 outcomes:
measure: Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)
timeFrame: into ICU 30 minutes
measure: Changes in the level of Cardiac output
timeFrame: into ICU 30 minutes
measure: Changes in the level of Heart Rate
timeFrame: into ICU 30 minutes
measure: Changes in the level of SVR
timeFrame: into ICU 30 minutes
measure: Changes in the level of SVRI
timeFrame: into ICU 30 minutes
measure: Changes in the level of Cardiac index
timeFrame: into ICU 30 minutes
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: the Affiliated Hospital of Yangzhou University, Yangzhou University
state: Jiangsu
Study officials:
References: