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Completed

NCT Number: NCT01187329

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

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.

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Key information

Age range

40 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

hyperinsulinemic normoglycemic clamp (HNC)

Other

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

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 24, 2010
Registry last updated
Nov 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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