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

This study is not yet open for participant recruitment.
Verified January 2013 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01780727
First received: January 23, 2013
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  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 100 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: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: February 2015 (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 hemodynmaic 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 1 of 6 procedures listed below:

    1. Orthopedic: Hip replacement, Knee replacement
    2. Vascular : Lower extremity bypass,Open abdominal aortic aneurysm repair
    3. General: Colon cancer resection, Other abdominal cancer resections

Exclusion Criteria:

  • Patients with expected hospital stay < 24 hours
  • Inability to undergo TEE and Transesphogeal 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
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: January 30, 2013
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 May 16, 2013