Cardiac Surgery Clinical Trial
Official title:
The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
NCT number | NCT01187329 |
Other study ID # | 10-526 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2010 |
Est. completion date | December 2013 |
Verified date | October 2018 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall research plan is to test the hypothesis that intraoperative treatment of hyperinsulinemic normoglycemic clamp (HNC) in cardiac surgical patients improves myocardial function and short-term outcomes compared with standard glucose management.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 84 Years |
Eligibility |
Inclusion Criteria: - Age 40 - 84 years old, Aortic stenosis, Scheduled for Aortic valve replacement. Exclusion Criteria: - Poor quality echocardiographic images unsuitable for analysis - Off -pump surgical procedure - Anticipated deep hypothermic circulatory arrest - Any contraindications to transesophageal echocardiogram (TEE) or other proposed intervention - Unable to give written informed consent (non-English speaking, vulnerable patients, etc.) |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myocardial Function: Left Ventricular Global Longitudinal Strain (%) | Left ventricular global longitudinal strain measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography. higher values (%) mean a worse outcome. |
end of surgery (closure), an average of 5 minutes | |
Primary | Intraoperative Left Ventricular (LV) Global Longitudinal Strain Rate | Left ventricular global longitudinal strain rate measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography. higher values mean a worse outcome |
end of surgery (closure) an average of 5 minutes | |
Secondary | Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain | Right ventricular global longitudinal strain measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography. higher values mean a worse outcome. |
end of surgery (closure) an average of 5 minutes | |
Secondary | Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain Rate | Right ventricular global longitudinal strain rate measured by intraoperative transesophageal echocardiography at end of surgery and assessed using off-line speckle-tracking echocardiography. higher values mean a worse outcome |
end of surgery (closure) an average of 5 minutes |
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