Clinical trial NCT01780727: Echo-guided Hemodynamic Management Strategy in Elderly Patients Undergoing Noncardiac Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Dysfunction, Left
Major Adverse Cardiac Events
Keywords: echocardiography
hemodynamic management
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 97
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients who undergo dynamic heart function changes during surgery
timeFrame: 2 years
Secondary outcomes:
measure: Safety of Echo-Guided Hemodynamic Management during surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: UNMC
name: Sasha K Shillcutt, MD
role: PRINCIPAL_INVESTIGATOR
References: