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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187329
• Other study ID #: 10-526
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: December 2013

Study information

• Verified date: October 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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.)

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Replacement
• Aortic Valve Stenosis
• Cardiac Surgery
• Hyperglycemia

Intervention

Other:
• hyperinsulinemic normoglycemic clamp (HNC)
Prior to anesthetic induction, a baseline blood glucose value will be obtained, followed by an insulin infusion of 5 mU.Kg-1.min-1. When blood glucose is <110 mg/dL, a variable continuous infusion of glucose (dextrose 20%) supplemented with potassium (40 mEq/L) and phosphate (30 mmol/L) is administered to preserve normoglycemia (80-110 mg/dL). The glucose infusion is titrated to target glucose levels by checking blood glucose every 5 - 15 min with Accu-Check (Roche Diagnostics, Switzerland) glucose monitor. At sternal closure, insulin infusion is decreased to 1 mU/Kg/min. On admission to the ICU, insulin treatment follows the ICU protocol. The dextrose infusion is slowly weaned off over 2 - 4 hrs maintaining blood glucose > 80 mg/dL. Arterial blood glucose is measured every 30 - 60 min for 2 hrs, then, as stated in ICU protocol.
• control group
Baseline arterial blood glucose will be obtained before anesthetic induction. Repeat measurements are performed every 30-90 min. Glucose >150 on CPB will receive insulin according to intraoperative protocol. After surgery, insulin is given according to ICU protocol. Target glucose < 180 mg/dL.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

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