Echo-guided Hemodynamic Management Strategy in Elderly Patients Undergoing Noncardiac Surgery
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|ClinicalTrials.gov Identifier: NCT01780727|
Recruitment Status : Recruiting
First Posted : January 31, 2013
Last Update Posted : July 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Dysfunction, Left Major Adverse Cardiac Events||Procedure: EGHEM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Arm 1 receives normal saline per the standard of care determined by the anesthesiologist.
Arm 2 receives normal saline or furosemide per the results of the intraoperative echocardiogram.
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||January 2019|
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.
- 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.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|