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

NCT01187329 | Completed Results DMC

• 1 other identifier: 10-526
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperglycemia; Aortic Valve Replacement; Aortic Stenosis; Cardiac Surgery

Keywords

Hyperglycemia; open heart surgery; bypass

Outcome Measures

Primary Outcomes (2)

• 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 (2)

• Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain

  end of surgery (closure) an average of 5 minutes

• Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain Rate

  end of surgery (closure) an average of 5 minutes

Study Arms (2)

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

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.

hyperinsulinemic normoglycemic clamp (HNC)

control group OTHER

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.

Also known as: glucose, standard of care

standard glucose management

Eligibility Criteria

• Age: 40 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 - 84 years old, Aortic stenosis, Scheduled for Aortic valve replacement.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (5)

• 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.

  PMID: 37526194 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.

  PMID: 35848424 DERIVED

• Zhang K, Sheu R, Zimmerman NM, Alfirevic A, Sale S, Gillinov AM, Duncan AE. A Comparison of Global Longitudinal, Circumferential, and Radial Strain to Predict Outcomes After Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 May;33(5):1315-1322. doi: 10.1053/j.jvca.2018.10.031. Epub 2018 Oct 24.

  PMID: 30581109 DERIVED

• Sonny A, Alfirevic A, Sale S, Zimmerman NM, You J, Gillinov AM, Sessler DI, Duncan AE. Reduced Left Ventricular Global Longitudinal Strain Predicts Prolonged Hospitalization: A Cohort Analysis of Patients Having Aortic Valve Replacement Surgery. Anesth Analg. 2018 May;126(5):1484-1493. doi: 10.1213/ANE.0000000000002684.

  PMID: 29200066 DERIVED

• 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.

  PMID: 26702865 DERIVED

MeSH Terms

Conditions

Hyperglycemia; Aortic Valve Stenosis

Interventions

Control Groups; Glucose; Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Hexoses; Monosaccharides; Sugars; Carbohydrates; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Andra E. Duncan, M.D
• Organization: Cleveland Clinic

DUNCANA@ccf.org

216-445-2372

Study Officials

• Andra Duncan, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 24, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 20, 2018
• Results First Posted: August 23, 2018

Record last verified: 2018-10

Locations

US (1)