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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 : August 23, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Hyperglycemia
Aortic Valve Replacement
Aortic Stenosis
Cardiac Surgery
Interventions: Other: hyperinsulinemic normoglycemic clamp (HNC)
Other: control group

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hyperinsulinemic Normoglycemic Clamp (HNC)

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

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.

Standard Glucose Management

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

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.


Participant Flow:   Overall Study
    Hyperinsulinemic Normoglycemic Clamp (HNC)   Standard Glucose Management
STARTED   50   50 
COMPLETED   49   48 
NOT COMPLETED   1   2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hyperinsulinemic Normoglycemic Clamp (HNC)

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

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.

Standard Glucose Management

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

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.

Total Total of all reporting groups

Baseline Measures
   Hyperinsulinemic Normoglycemic Clamp (HNC)   Standard Glucose Management   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   48   97 
Age 
[Units: Years]
Mean (Standard Deviation)
 70  (9)   70  (11)   70  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  26.5%      17  35.4%      30  30.9% 
Male      36  73.5%      31  64.6%      67  69.1% 


  Outcome Measures

1.  Primary:   Myocardial Function: Left Ventricular Global Longitudinal Strain (%)   [ Time Frame: end of surgery, closure ]

2.  Primary:   Intraoperative Left Ventricular (LV) Global Longitudinal Strain Rate   [ Time Frame: end of surgery, closure ]

3.  Secondary:   Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain   [ Time Frame: end of surgery, closure. ]

4.  Secondary:   Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain Rate   [ Time Frame: end of surgery, closure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Andra E. Duncan, M.D
Organization: Cleveland Clinic
phone: 216-445-2372
e-mail: DUNCANA@ccf.org


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 Submitted: August 19, 2010
First Posted: August 24, 2010
Results First Submitted: June 4, 2018
Results First Posted: August 23, 2018
Last Update Posted: August 23, 2018