InsulinNCT05464966
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
A study testing Glucose insulin potassium in people with Insulin, run by Yangzhou University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Insulin
- What is being tested?
- Glucose insulin potassium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu
About this study
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
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
- Being tested
- Glucose insulin potassium
- Keywords
- Insulin, Perioperative period, Blood glucose, Heart protection
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose insulin potassiumDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Glucose-insulin-potassium | Experimental | Not described Receives: Drug: Glucose insulin potassium |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the coronary sinus blood flow spectrum
coronary sinus blood flow spectrum changes such as SVTI、DVTI、AVTI are assessed by TEE
Measured: 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
Measured: 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 (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: into ICU 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Jun 2022
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsulinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Zhang, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464966
- Sponsor's protocol ID
- 20220515
- Status last verified
- Jan 2024
- First submitted
- 15 May 2022
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05464966
- Acronym / sponsor ID
- 20220515
- Conditions
- Insulin
- Keywords
- Insulin, Perioperative period, Blood glucose, Heart protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Yangzhou UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose-insulin-potassium | Experimental | Drug: Glucose insulin potassium |
| Control | No intervention | – |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose insulin potassiumAfter 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 | Drug | Glucose-insulin-potassium |
Primary outcome
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
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
6 secondary outcomes
Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure)
Time frame: into ICU 30 minutes
Changes in the level of Cardiac output
Time frame: into ICU 30 minutes
Changes in the level of Heart Rate
Time frame: into ICU 30 minutes
Changes in the level of SVR
Time frame: into ICU 30 minutes
Changes in the level of SVRI
Time frame: into ICU 30 minutes
Changes in the level of Cardiac index
Time frame: into ICU 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose insulin potassium in people with Insulin, run by Yangzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.