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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01780727
Recruitment Status : Recruiting
First Posted : January 31, 2013
Last Update Posted : July 6, 2017
Information provided by (Responsible Party):
Sasha Shillcutt MD, University of Nebraska

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ventricular Dysfunction, Left Major Adverse Cardiac Events Procedure: EGHEM Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
No Intervention: Standard Hemodynamic Management (SHEM)
use of standard hemodynamic management
Experimental: EGHEM
use of echocardiography guided hemodynamic management to control fluid and drug therapy.
Procedure: EGHEM
Echocardiography guided hemodynamic management. Subjects in this arm will undergo intraoperative transesophageal echocardiography as part of the study.

Primary Outcome Measures :
  1. Number of Patients who undergo dynamic heart function changes during surgery [ Time Frame: 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 :
  1. Safety of Echo-Guided Hemodynamic Management during surgery [ Time Frame: 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)

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01780727

United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-1145
Contact: Sasha K Shillcutt, MD    402-559-2849   
Contact: Lace D Petry, RN    402.559.2905   
Sponsors and Collaborators
University of Nebraska
Principal Investigator: Sasha K Shillcutt, MD UNMC

Responsible Party: Sasha Shillcutt MD, Principal Investigator, University of Nebraska Identifier: NCT01780727     History of Changes
Other Study ID Numbers: 630-12-FB
First Posted: January 31, 2013    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

Keywords provided by Sasha Shillcutt MD, University of Nebraska:
hemodynamic management

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases