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

Primary Purpose

Ventricular Dysfunction, Left, Major Adverse Cardiac Events

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

EGHEM

About this trial

This is an interventional treatment trial for Ventricular Dysfunction, Left focused on measuring echocardiography, hemodynamic management

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Hemodynamic Management (SHEM)

EGHEM

Arm Description

use of standard hemodynamic management

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

Outcomes

Primary Outcome Measures

Number of Patients who undergo dynamic heart function changes during surgery

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

Safety of Echo-Guided Hemodynamic Management during surgery

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)

Full Information

NCT ID

NCT01780727

First Posted

January 23, 2013

Last Updated

September 13, 2023

Sponsor

University of Nebraska

1. Study Identification

Unique Protocol Identification Number

NCT01780727

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

September 1, 2014 (Actual)

Primary Completion Date

May 31, 2018 (Actual)

Study Completion Date

August 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nebraska

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventricular Dysfunction, Left, Major Adverse Cardiac Events

Keywords

echocardiography, hemodynamic management

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Hemodynamic Management (SHEM)

Arm Type

No Intervention

Arm Description

use of standard hemodynamic management

Arm Title

EGHEM

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

EGHEM

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Patients who undergo dynamic heart function changes during surgery

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Safety of Echo-Guided Hemodynamic Management during surgery

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sasha K Shillcutt, MD

Organizational Affiliation

UNMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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