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

NeuroTherapia, Inc.

Status: Completed

Conditions: Cardiac Surgery; Aortic Valve Replacement; Hyperglycemia; Aortic Stenosis

Treatments: Other: control group; Other: hyperinsulinemic normoglycemic clamp (HNC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01187329

10-526

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 40 to 84 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

hyperinsulinemic normoglycemic clamp (HNC)

Experimental group

Description:

Patients will be randomized to receive treatment with HNC during cardiac surgery.

Treatment:

Other: hyperinsulinemic normoglycemic clamp (HNC)

standard glucose management

Placebo Comparator group

Description:

Patients will be randomized to receive treatment with standard glucose management during cardiac surgery.

Treatment:

Other: control group