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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
Last Update Posted : June 13, 2014
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
The Cleveland Clinic

August 19, 2010
August 24, 2010
June 13, 2014
October 2010
August 2013   (Final data collection date for primary outcome measure)
Myocardial function [ Time Frame: end of surgery, closure ]
Myocardial function measured echocardiographically by global longitudinal systolic strain and strain rate using speckle tracking imaging at end of surgery.
Myocardial function [ Time Frame: end of surgery, closure ]
Myocardial function measured echocardiographically by global longitudinal systolic strain using speckle tracking imaging at end of surgery.
Complete list of historical versions of study NCT01187329 on ClinicalTrials.gov Archive Site
  • diastolic function [ Time Frame: end of surgery, closure ]
    Echocardiographic measures of diastolic function, including transmitral deceleration time (EDT) and velocity of propagation (vp).
  • myocardial systolic function [ Time Frame: Day 3 - Day 5, post operative, end of surgery, closure. ]
    Additional echocardiographic measures of myocardial systolic function, such as myocardial velocities measured by tissue Doppler imaging and left ventricular ejection fraction (LVEF), and postoperative strain and strain rate.
  • right ventricular function [ Time Frame: end of surgery, closure ]
    right ventricular function as assessed by right ventricular longitudinal strain and strain rate
  • activation of glucose metabolic pathways [ Time Frame: intraoperative ]
    assessment of the activation of glycolysis, pyruvate oxidation pathway, and hexosamine biosynthetic pathway.
  • diastolic function [ Time Frame: end of surgery, closure ]
    Echocardiographic measures of diastolic function, including transmitral deceleration time (EDT), velocity of propagation (vp) and intraventricular pressure gradients (IVPG).
  • myocardial systolic function [ Time Frame: Day 3 - Day 5, post operative ]
    Additional echocardiographic measures of myocardial systolic function, such as myocardial velocities measured by tissue Doppler imaging and left ventricular ejection fraction (LVEF).
Not Provided
Not Provided
 
The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
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.

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).

Specific Aim #2 and #3 To determine the mechanism of HNC by laboratory analysis of right atrial tissue.

Specific Aim #2 To determine if HNC decreases flux via HBP and cellular markers of injury.

Specific Aim #3 To determine if HNC augments glucose uptake and utilization.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Hyperglycemia
  • Aortic Valve Replacement
  • Aortic Stenosis
  • 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.
  • 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
  • Experimental: hyperinsulinemic normoglycemic clamp (HNC)
    Patients will be randomized to receive treatment with HNC during cardiac surgery.
    Intervention: Other: hyperinsulinemic normoglycemic clamp (HNC)
  • Placebo Comparator: standard glucose management
    Patients will be randomized to receive treatment with standard glucose management during cardiac surgery.
    Intervention: Other: control group
Duncan AE, Sarwar S, Kateby Kashy B, Sonny A, Sale S, Alfirevic A, Yang D, Thomas JD, Gillinov M, Sessler DI. Early Left and Right Ventricular Response to Aortic Valve Replacement. Anesth Analg. 2017 Feb;124(2):406-418. doi: 10.1213/ANE.0000000000001108.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Same as current
December 2013
August 2013   (Final data collection date for primary outcome measure)

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.)
Sexes Eligible for Study: All
40 Years to 84 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01187329
10-526
Yes
Not Provided
Not Provided
The Cleveland Clinic
The Cleveland Clinic
National Institutes of Health (NIH)
Principal Investigator: Andra Duncan, MD The Cleveland Clinic
The Cleveland Clinic
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP