Brief Title
The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
Official Title
The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
Brief Summary
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.
Detailed Description
Specific Aim #1:To determine whether intraoperative use of HNC affords cardioprotective benefits measured by improved echocardiographic measures of myocardial function, serum markers of cardiomyocyte injury, and hemodynamic indices measured immediately (at end of surgery) and during the short-term (initial hospitalization).
Study Type
Interventional
Primary Outcome
Myocardial Function: Left Ventricular Global Longitudinal Strain (%)
Secondary Outcome
Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain
Condition
Hyperglycemia
Intervention
hyperinsulinemic normoglycemic clamp (HNC)
Study Arms / Comparison Groups
hyperinsulinemic normoglycemic clamp (HNC)
Description: Patients will be randomized to receive treatment with HNC during cardiac surgery.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
100
Start Date
October 2010
Completion Date
December 2013
Primary Completion Date
August 2013
Eligibility Criteria
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.)
Gender
All
Ages
40 Years - 84 Years
Accepts Healthy Volunteers
No
Contacts
Andra Duncan, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01187329
Organization ID
10-526
Responsible Party
Sponsor
Study Sponsor
The Cleveland Clinic
Collaborators
National Institutes of Health (NIH)
Study Sponsor
Andra Duncan, MD, Principal Investigator, The Cleveland Clinic
Verification Date
October 2018