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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01187329
First received: August 19, 2010
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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 Intervention
Hyperglycemia
Aortic Valve Replacement
Aortic Stenosis
Cardiac Surgery
Other: hyperinsulinemic normoglycemic clamp (HNC)
Other: control group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Myocardial function [ Time Frame: end of surgery, closure ] [ Designated as safety issue: No ]
    Myocardial function measured echocardiographically by global longitudinal systolic strain and strain rate using speckle tracking imaging at end of surgery.


Secondary Outcome Measures:
  • diastolic function [ Time Frame: end of surgery, closure ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    right ventricular function as assessed by right ventricular longitudinal strain and strain rate

  • activation of glucose metabolic pathways [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
    assessment of the activation of glycolysis, pyruvate oxidation pathway, and hexosamine biosynthetic pathway.


Enrollment: 100
Study Start Date: October 2010
Study Completion Date: December 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

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.

  Eligibility

Ages Eligible for Study:   40 Years to 84 Years
Genders Eligible for Study:   Both
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.)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01187329

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Andra Duncan, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01187329     History of Changes
Other Study ID Numbers: 10-526
Study First Received: August 19, 2010
Last Updated: June 12, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 26, 2014