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

University of Nebraska

Status: Completed

Conditions: Ventricular Dysfunction, Left; Major Adverse Cardiac Events

Treatments: Procedure: EGHEM

Study type: Interventional

Funder types: Other

Identifiers

NCT01780727

0630-12-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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97 participants in 2 patient groups

Standard Hemodynamic Management (SHEM)

No Intervention group

Description:

use of standard hemodynamic management

EGHEM

Experimental group

Description:

use of echocardiography guided hemodynamic management to control fluid and drug therapy.

Treatment:

Procedure: EGHEM