The Effect of the Hyperinsulinemic Normoglycemic Clamp on... | NCT01187329

NCT01187329

Status Module

Sponsor/Collaborators Module

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
hyperinsulinemic normoglycemic clamp (HNC)	Experimental	Patients will be randomized to receive treatment with HNC during cardiac surgery.	Other: hyperinsulinemic normoglycemic clamp (HNC)
standard glucose management	Placebo Comparator	Patients will be randomized to receive treatment with standard glucose management during cardiac surgery.	Other: control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Myocardial Function: Left Ventricular Global Longitudinal Strain (%)	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.	end of surgery (closure), an average of 5 minutes
Intraoperative Left Ventricular (LV) Global Longitudinal Strain Rate	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	end of surgery (closure) an average of 5 minutes

Secondary Outcomes

Measure	Description	Time Frame
Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain	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.	end of surgery (closure) an average of 5 minutes

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Andra Duncan, MD	The Cleveland Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic Foundation		Cleveland	Ohio	44195	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37526194	Derived	Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
35848424	Derived	Zhang K, Kumar N, Alfirevic A, Sale S, You J, Bauer A, Duncan AE. Left Ventricular Twist Mechanics Before and After Aortic Valve Replacement: A Feasibility Study and Exploratory Analysis. Semin Cardiothorac Vasc Anesth. 2022 Sep;26(3):226-236. doi: 10.1177/10892532221114791. Epub 2022 Jul 18.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00049 BG00148 BG00297

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-16.8± 4.6 OG001-15.9± 4.6

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		t-test, 2 sided		0.11		Mean Difference (Final Values)	-1.2			2-Sided	97.5	-2.87	0.48					Superiority

Primary

Intraoperative Left Ventricular (LV) Global Longitudinal Strain Rate

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

some patient's echocardiography were low quality and can not be used

Posted

Mean

Standard Deviation

Percent / sec

end of surgery (closure) an average of 5 minutes

ID	Title	Description
OG000	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.
OG001	Standard Glucose Management

Secondary

Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain

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.

some patient's echocardiography were low quality and can not be used

Posted

Mean

Standard Deviation

percentage of myocardial shortening

end of surgery (closure) an average of 5 minutes

ID	Title	Description
OG000	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.
OG001	Standard Glucose Management

Secondary

Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain Rate

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

some patient's echocardiography were low quality and can not be used

Posted

Mean

Standard Deviation

Percent / sec

end of surgery (closure) an average of 5 minutes

ID	Title	Description
OG000	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.
OG001	Standard Glucose Management

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	49	0	49	0	49
EG001	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.	0	48	0	48	0	48

Title	Organization	Phone	Extension	Email
Andra E. Duncan, M.D	Cleveland Clinic	216-445-2372		DUNCANA@ccf.org

ID	Term
D006943	Hyperglycemia
D001024	Aortic Valve Stenosis

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D000082862	Aortic Valve Disease
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014694	Ventricular Outflow Obstruction

ID	Term
D035061	Control Groups
D005947	Glucose
D059039	Standard of Care

Ancestor Terms

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design
D008722	Methods
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation