Major Adverse Cardiac Events, Ventricular Dysfunction, Left
Conditions
Keywords
echocardiography, hemodynamic management
Brief summary
Elderly patients are the fastest growing surgical population and have an increased risk of postoperative cardiac problems. Diastolic dysfunction, or the reduced ability of the heart' s ventricles to fill completely, is common in the elderly population and increases the risk of major adverse cardiac events after surgery. This study will measure diastolic filling and implement fluid and drug management during surgery to determine whether this reduces serious cardiac events related to diastolic dysfunction after surgery in this high-risk population.
Detailed description
Elderly patients are the fastest growing surgical population and present with increased risk of postoperative cardiac problems, especially congestive heart failure. Diastolic dysfunction is common in the elderly population and increases the risk of major adverse cardiac events after surgery. This project will use dynamic measurements of diastolic filling pressures by echocardiography for goal-directed fluid and drug management during surgery to determine whether this reduces serious cardiac events related to diastolic dysfunction after surgery in this high-risk population.
Interventions
PROCEDUREEGHEM
Echocardiography guided hemodynamic management. Subjects in this arm will undergo intraoperative transesophageal echocardiography as part of the study.
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Arm 1 receives normal saline per the standard of care determined by the anesthesiologist. Arm 2 receives normal saline or furosemide per the results of the intraoperative echocardiogram.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 70 years and older * Echocardiographic Evidence of Grade I, II or III LVDD on Preoperative Transthoracic Echocardiography (TTE) examination * Undergoing Vascular Surgery including but not limited to : Lower extremity bypass,Open abdominal aortic aneurysm repair
Exclusion criteria
* Patients with expected hospital stay \< 24 hours * Inability to undergo TEE and Transesophageal Echocardiography(TTE) * Clinical evidence/suspicion of elevated Intercranial Pressure (ICP) * Preoperative shock or systemic sepsis * Emergency operation * American Society of Anesthesiologists Status V * Participation in another clinical trial * General Anesthesia not planned for procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients who undergo dynamic heart function changes during surgery | 2 years | We will test the hypothesis that Left Ventricular Diastolic Dysfunction (LVDD) undergoes dynamic changes perioperatively. A. We will preoperatively identify 200 elderly subjects to provide 80% power to detect a change in LVDD undergoing noncardiac surgery using a 0.01 level two-sided paired t-test. B. We will assess changes in LVDD in these subjects based on hourly intraoperative echocardiography data points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Echo-Guided Hemodynamic Management during surgery | 1 year | We will test the hypothesis that goal-directed Echocardiography Guided Hemodynamic Management (EGHEM) used in elderly subjects with LVDD improves postoperative clinical outcomes. A. We will determine the ability of goal-directed EGHEM to maintain or improve intraoperative LVDD. B. We will determine the ability of goal-directed EGHEM to reduce postoperative Major Adverse Cardiac Event (MACE) |
Countries
United States
Outcome results
None listed