Echo-guided Hemodynamic Management Strategy in Elderly Patients Undergoing Noncardiac Surgery
This trial is active, not recruiting.
|Conditions||ventricular dysfunction, left, major adverse cardiac events|
|Sponsor||University of Nebraska|
|Start date||September 2014|
|End date||May 2017|
|Trial size||120 participants|
|Trial identifier||NCT01780727, 630-12-FB|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
Number of Patients who undergo dynamic heart function changes during surgery
time frame: 2 years
Safety of Echo-Guided Hemodynamic Management during surgery
time frame: 1 year
Male or female participants at least 70 years old.
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
|Official title||Echocardiography-guided Hemodynamic (EGHEM) Management Strategy to Improve Clinical Outcomes for Elderly Patients With Left Ventricular Diastolic Dysfunction (LVDD) Undergoing Non-cardiac Surgery|
|Principal investigator||Sasha K Shillcutt, MD|
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