Echocardiography Management for Patients Requiring Care for Non-Cardiac Surgery (EGHEM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01050361|
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : May 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Risk Factors||Procedure: Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Echocardiography-Guided Hemodynamic Management Strategy for Patients Requiring Perioperative Care for Non-Cardiac Surgery|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
The intervention group will be called EGHEM - Echo Guided HEmodyanmic Management - and will receive their intraoperative maintenance fluid and possible drug therapy (furosemide) based on their hourly intraoperative LVDD grade.
Procedure: Transthoracic Echocardiogram (TTE)/Transesophageal Echocardiogram (TEE)
Duration lasts the entire operation.
No Intervention: SHEM
The control group will be
called SHEM - Standard HEmodynamic Management - and will NOT receive the study intervention, but will receive standard anesthesia and hemodynamic management based on current standards within the institution.
- To use standard cardiac ultrasound-generated data points in addition to systemic blood pressure and ECG signal to assess, manage, modify, and optimize the patient cardiac preload, afterload, heart rate and contractility in the perioperative period. [ Time Frame: 3 Years ]
- To reduce perioperative morbidity and mortality associated with congestive heart failure for non-cardiac surgeries. [ Time Frame: 3 years ]
- To evaluate and support the conclusion that echocardiography is a superior technology for identifying these changes and managing the unique cardiovascular challenges of the UNMC patient population. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050361
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Tara R Brakke, MD||University of Nebraska|