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

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ClinicalTrials.gov Identifier: NCT01187329
Recruitment Status : Completed
First Posted : August 24, 2010
Results First Posted : August 23, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hyperglycemia Aortic Valve Replacement Aortic Stenosis Cardiac Surgery Other: hyperinsulinemic normoglycemic clamp (HNC) Other: control group Not Applicable

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
Study Start Date : October 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: hyperinsulinemic normoglycemic clamp (HNC)
Patients will be randomized to receive treatment with HNC during cardiac surgery.
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.

Placebo Comparator: standard glucose management
Patients will be randomized to receive treatment with standard glucose management during cardiac surgery.
Other: 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.
Other Names:
  • glucose
  • standard of care




Primary Outcome Measures :
  1. Myocardial Function: Left Ventricular Global Longitudinal Strain (%) [ Time Frame: 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.


  2. Intraoperative Left Ventricular (LV) Global Longitudinal Strain Rate [ Time Frame: 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 :
  1. Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain [ Time Frame: 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.


  2. Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain Rate [ Time Frame: 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




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Ages Eligible for Study:   40 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187329


Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
National Institutes of Health (NIH)
Investigators
Principal Investigator: Andra Duncan, MD The Cleveland Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01187329     History of Changes
Other Study ID Numbers: 10-526
First Posted: August 24, 2010    Key Record Dates
Results First Posted: August 23, 2018
Last Update Posted: November 20, 2018
Last Verified: October 2018

Keywords provided by The Cleveland Clinic:
Hyperglycemia
open heart surgery
bypass

Additional relevant MeSH terms:
Hyperglycemia
Aortic Valve Stenosis
Glucose Metabolism Disorders
Metabolic Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction