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

Ventricular Dysfunction, Left Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01780727
• Other study ID #: 0630-12-FB
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: August 27, 2018

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 27, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Secondary	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)	1 year