Clinical trial NCT01187329: The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
Official title: The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Aortic Valve Replacement
Aortic Stenosis
Cardiac Surgery
Keywords: Hyperglycemia
open heart surgery
bypass
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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.)

Primary outcomes:
measure: Myocardial Function: Left Ventricular Global Longitudinal Strain (%)
timeFrame: end of surgery (closure), an average of 5 minutes
measure: Intraoperative Left Ventricular (LV) Global Longitudinal Strain Rate
timeFrame: end of surgery (closure) an average of 5 minutes
Secondary outcomes:
measure: Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain
timeFrame: end of surgery (closure) an average of 5 minutes
measure: Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain Rate
timeFrame: end of surgery (closure) an average of 5 minutes
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Andra Duncan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.