N/A
N=100
The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose
Hyperglycemia · Aortic Valve Replacement · Aortic Stenosis · Cardiac Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01187329 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Myocardial Function: Left Ventricular Global Longitudinal Strain (%) — -16.8; -15.9 percentage of myocardial shortening — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- hyperinsulinemic normoglycemic clamp (HNC) (Other); control group (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Function: Left Ventricular Global Longitudinal Strain (%) |
-16.8; -15.9 | 0.11 |
| PRIMARY Intraoperative Left Ventricular (LV) Global Longitudinal Strain Rate |
-1.1; -1.0 | 0.007 sig |
| SECONDARY Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain |
-17.2; -17.3 | 0.57 |
| SECONDARY Intraoperative Right Ventricular (RV) Systolic Longitudinal Strain Rate |
-1.1; -1.1 | 0.45 |
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.
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.)
Data sourced from ClinicalTrials.gov (NCT01187329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.