Echo-guided Hemodynamic Management Strategy in Elderly Patients Undergoing Noncardiac Surgery

Not Applicable

Completed

• Conditions: Ventricular Dysfunction, Left; Major Adverse Cardiac Events
• Interventions: Procedure: EGHEM

• Registration Number: NCT01780727
• Lead Sponsor: University of Nebraska

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.

Study Timeline

• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-01-31
• Study Start: 2014-09-01
• Primary Completion: 2018-05-31
• Study Completion: 2018-08-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EGHEM	EGHEM	use of echocardiography guided hemodynamic management to control fluid and drug therapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States