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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-01

Study Completion Date

2018-08-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ventricular Dysfunction, Left Major Adverse Cardiac Events

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Hemodynamic Management (SHEM)

use of standard hemodynamic management

Group Type NO_INTERVENTION

No interventions assigned to this group

EGHEM

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

Group Type EXPERIMENTAL

EGHEM

Intervention Type PROCEDURE

Echocardiography guided hemodynamic management. Subjects in this arm will undergo intraoperative transesophageal echocardiography as part of the study.

Interventions

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EGHEM

Echocardiography guided hemodynamic management. Subjects in this arm will undergo intraoperative transesophageal echocardiography as part of the study.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No