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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01780727
First received: January 23, 2013
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Ventricular Dysfunction, Left
Major Adverse Cardiac Events
Procedure: EGHEM
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Number of Patients who undergo dynamic heart function changes during surgery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    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)



Estimated Enrollment: 120
Study Start Date: September 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780727

Locations
United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198-1145
Contact: Sasha K Shillcutt, MD    402-559-2849    sshillcu@unmc.edu   
Contact: Stacey L Therrien, BS    402.559.2905    stherrien@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Sasha K Shillcutt, MD UNMC
  More Information

No publications provided

Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT01780727     History of Changes
Other Study ID Numbers: 630-12-FB
Study First Received: January 23, 2013
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
echocardiography
hemodynamic management

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

ClinicalTrials.gov processed this record on August 01, 2014