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Completed

NCT Number: NCT01780727

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

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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Key information

Conditions

Ventricular Dysfunction, Left Cardiovascular Diseases Heart Diseases Major Adverse Cardiac Events Ventricular Dysfunction

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EGHEM

Procedure

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

Echocardiography-guided Hemodynamic (EGHEM) Management Strategy to Improve Clinical Outcomes for Elderly Patients With Left Ventricular Diastolic Dysfunction (LVDD) Undergoing Non-cardiac Surgery

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 31, 2013
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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