The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose

Not Applicable

Completed

• Conditions: Hyperglycemia; Aortic Valve Replacement; Aortic Stenosis; Cardiac Surgery
• Interventions: Other: control group; Other: hyperinsulinemic normoglycemic clamp (HNC)

• Registration Number: NCT01187329
• Lead Sponsor: The Cleveland Clinic

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 Timeline

• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Study Start: 2010-10
• Primary Completion: 2013-08
• Study Completion: 2013-12
• Results First Submitted: 2018-06-04
• Results First Submitted QC: 2018-07-24
• Results First Posted: 2018-08-23
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard glucose management	control group	Patients will be randomized to receive treatment with standard glucose management during cardiac surgery.
hyperinsulinemic normoglycemic clamp (HNC)	hyperinsulinemic normoglycemic clamp (HNC)	Patients will be randomized to receive treatment with HNC during cardiac surgery.

Primary Outcome Measures

Name	Time	Method
Myocardial Function: Left Ventricular Global Longitudinal Strain (%)	end of surgery (closure), an average of 5 minutes	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.
Intraoperative Left Ventricular (LV) Global Longitudinal Strain Rate	end of surgery (closure) an average of 5 minutes	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

Secondary Outcome Measures

Name	Time	Method
Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain	end of surgery (closure) an average of 5 minutes	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.
Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain Rate	end of surgery (closure) an average of 5 minutes	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

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States