Trial Outcomes & Findings for The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose (NCT NCT01187329)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

end of surgery (closure), an average of 5 minutes

Results posted on

2018-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	50	50
Overall Study COMPLETED	49	48
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hyperinsulinemic Normoglycemic Clamp (HNC) n=49 Participants 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 n=48 Participants 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 n=97 Participants Total of all reporting groups
Age, Continuous	70 years STANDARD_DEVIATION 9 • n=5 Participants	70 years STANDARD_DEVIATION 11 • n=7 Participants	70 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	31 Participants n=7 Participants	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: end of surgery (closure), an average of 5 minutes

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

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.

Outcome measures

Outcome measures
Measure	Hyperinsulinemic Normoglycemic Clamp (HNC) n=36 Participants 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 n=36 Participants 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.
Myocardial Function: Left Ventricular Global Longitudinal Strain (%)	-16.8 percentage of myocardial shortening Standard Deviation 4.6	-15.9 percentage of myocardial shortening Standard Deviation 4.6

PRIMARY outcome

Timeframe: end of surgery (closure) an average of 5 minutes

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

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

Outcome measures

Outcome measures
Measure	Hyperinsulinemic Normoglycemic Clamp (HNC) n=33 Participants 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 n=34 Participants 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.
Intraoperative Left Ventricular (LV) Global Longitudinal Strain Rate	-1.1 Percent / sec Standard Deviation 0.3	-1.0 Percent / sec Standard Deviation 0.3

SECONDARY outcome

Timeframe: end of surgery (closure) an average of 5 minutes

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

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.

Outcome measures

Outcome measures
Measure	Hyperinsulinemic Normoglycemic Clamp (HNC) n=26 Participants 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 n=28 Participants 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.
Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain	-17.2 percentage of myocardial shortening Standard Deviation 4.3	-17.3 percentage of myocardial shortening Standard Deviation 3.7

SECONDARY outcome

Timeframe: end of surgery (closure) an average of 5 minutes

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

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

Outcome measures

Outcome measures
Measure	Hyperinsulinemic Normoglycemic Clamp (HNC) n=26 Participants 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 n=28 Participants 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.
Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain Rate	-1.1 Percent / sec Standard Deviation 0.3	-1.1 Percent / sec Standard Deviation 0.4

Adverse Events

Hyperinsulinemic Normoglycemic Clamp (HNC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Glucose Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andra E. Duncan, M.D

Cleveland Clinic

Phone: 216-445-2372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place