Echo-guided Hemodynamic Management Strategy in Elderly Patients Undergoing Noncardiac Surgery
Ventricular Dysfunction, Left
Major Adverse Cardiac Events
|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|
- 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.
- 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)
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
No Intervention: Standard Hemodynamic Management (SHEM)
use of standard hemodynamic management
use of echocardiography guided hemodynamic management to control fluid and drug therapy.
Echocardiography guided hemodynamic management. Subjects in this arm will undergo intraoperative transesophageal echocardiography as part of the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01780727
|United States, Nebraska|
|University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198-1145|
|Contact: Sasha K Shillcutt, MD 402-559-2849 firstname.lastname@example.org|
|Contact: Lace D Petry, RN 402.559.2905 email@example.com|
|Principal Investigator:||Sasha K Shillcutt, MD||UNMC|