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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01780727
Other study ID # 0630-12-FB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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